• Toxicological Research
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• v.9 no.1
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• pp.119-123
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• 1993

LBD-007, a newly developed recombinant human interferon ${\alpha}$A, was tested for primary eye and skin irritation in male New Zealand White rabbits. In the primary eye irritation test, 0.1ml of a solution of LBD-007 was instilled into the eye. In rinsing group, the eye was washed with water 30 seconds after instillation. No reaction was observed at the cornea, iris and conjunctivae by LBD-007. In the primary skin irritation test, LBD-007 was applied to the back of rabbits for 24 hours. Primary irritation index was "0" in test and control sites of all animals. Thus LBD-007 was evaluated as a non-irritant on the basis of the criteria of Draize et al.,(1994).

• Toxicological Research
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• v.9 no.1
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• pp.125-132
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• 1993

Antigenic potential of recombinant human growth hormone (LBD-007), a newly developed drug for growth hormone deficiency, was investigated in mice and guinea pigs. 1. Mice showed production of antibodies against LBD-009 (1.5IU/kg) with aluminum hydroxide gel(alum) as an adjuvant, Judaged by the heterologous anaphylaxis (PCA) test using rats. On the other hand, antibodies against ovalbumin (OVA) inoculated with alum were definitely detected. 2. In the studies with guinea pigs, both the inoculation of LBD-009 (0.15IU/kg-1.5IU/kg) only and of LBD-009 with complete Freund's adjuvant (CFA) as an adjuvant did produce weak positive reactions in homologous passive cutaneous anaphylaxis (PCA). On the other hand, the inoculation of ovalbumin with complete Freund's adjuvant (CFA) produced positive reaction in PCA.

• Biomolecules & Therapeutics
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• v.1 no.2
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• pp.266-269
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• 1993

The acute toxicity of a recombinant human interferon $\alpha$A (code name: LBD-007) was evaluated in both sexes of ICR mice, 5 weeks old, by the oral, subcutaneous and intravenous routes of administration. Based on the results, LBD-007 was not considered to induce any toxic effect on the mice in mortalities, clinical findigs, body weights and gross findings. It is suggested that LD$_{50}$ values in mice would be $>48{\times}10^8$ IU/kg in the oral, subcutaneous or intravenous routes.s.

• Toxicological Research
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• v.9 no.1
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• pp.107-118
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• 1993

LBD-007, a newly developed recombinant human interferon alphaA, was at dose levels of 0.3 $\times$$10^6$ , 6 $\times$ $10^6$ and 12 $\times$ $10^6$ IU/kg/day administered subcutaneously to pregnant and subsequent delivered SpragueDawley rats from day 17 of gestation through day 21 of lactation. Effects of test substance on dams and growth, behaviour and mating performance of F1 offspring were examined. 1. No treatmene-related changes in clinical signs, food consumption, body weight, pregnant period and necropsy findings were observed in dams.

• Toxicological Research
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• v.9 no.1
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• pp.73-82
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• 1993

LBD-007, a newly developed recombinant human interferon alphaA, was at dose levels of 0, 3$\times$$10^6$, 6$\times$ $10^6$ and 12$\times$1$10^6$ IU/kg/day administered subcutaneously to Sprague-Dawley male rats from premating to mating period and to females from premating to early gestation period. Effects of test agent on reproductive performance of both sexes and embryonic development were examined. 1. No treatment-relared changes in food consumption, body weight and necropsy findings were observed in parent animals.

• Toxicological Research
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• v.9 no.1
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• pp.99-105
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• 1993

LBD-007, a newly developed recombinant human interferon alphaA, was at dose levels of 0.3 $\times$$10^6$ , 6 $\times$ $10^6$ and 12 $\times$ $10^6$ IU/kg/day administered subcutaneously to pregnant New Zealand White rabbits during the organogenetic period. Cyclophosphamide was used as a positive control. All pregnant females were subjected to the caesarean section on day 28 of pregnancy. Effect of test substance on dams and embryonal development of fetuses were examined. 1. No treatment-related changes in clinical signs, food consuption, body weight and necropsy findings of dams were observed.

• Toxicological Research
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• v.9 no.1
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• pp.83-98
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• 1993

LBD-007, a newly developed recombinant human interferon alpha A, was at dose levels of 0, 3 $\times$ $10^6$, 6 $\times$ $10^6$ and 12 $\times$ $10^6$ IU/kg/day administered subctaneously to pregnant Sprague-Dawley rats during the organogenetic period. Ethylenethiourea was used as a positive control. 2/3 of dams per group were subjected to caesarean section on day 20 of pregnancy and the remaining 10 dams per group were allowed to deliver. Effects of test substance on dams, embryonal development development of F1 fetuses, as well as growth, behaviour and mating performance of F1 offspring were examined. 1. No treatment-related changes in clinical signs, food consumption, body weight and necropsy findings of dams were observed.