Octamethylenediamine

Endpoint summary

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (sensitising)

Additional information:

skin sensitisation:

The test substance Octamethylenediamine was investigated upon its skin sensitising potential on young Dunkan-Hartley albino guinea pigs according to the procedure of the Haskell Laboratory, Newark, Delaware (Henry, 1987). The study was conducted according to CPA Good Laboratory Practice Regulations on shaved, intact skin of 10 male animals. p-Phenylenediamine was used as positive control. The test substance concentrations in the challenge phase were 0.4 % and 4 % (w/v) as suspensions in distilled water. The primary irritation phase was conducted by applying and lightly rubbing of the test suspensions and scoring was done 24 and 48 h after this dermal application. Two days later the induction phase was initiated with the same animals and consisted of a series of 4 sacral intradermal injections (1 time per week) of 0.1 mL of a 1.0 % (w/v) test suspension. After about 24 h skin responses were evaluated. The challenge started two weeks later by applying and lightly rubbing 4 % and 0.4 % of the test material suspension onto separate sites of shaved, intact shoulder skin. In 6 of 10 animals moderate erythema was recorded and 2 of 10 guinea pigs had mild erythema at the 4 % concentration site by 24 hours. After 48 hours, 1 guinea pig exhibited erythema and edema and 6 guinea pigs had moderate erythema. Positive control substance produced a significant response in 10 of 10 animals which is evident for valid test system. As overall result, at challenge, the test substance produced a significant score increase in 7 animals over the reponse observed during the induction phase. The study results clearly show the skin sensitizing potential of the test substance but are not suited for subclassification into skin sensitization Category 1A or 1B.

Migrated from Short description of key information:
dermal sensitisation study in guinea pigs, Hasekell Laboratories 1987: sensitising

Justification for classification or non-classification

Octamethylenediamine was classified as skin sensitizer Category 1 (EU: R43; H317) according to the criteria of EU Directive 67/548/EEC and EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No 1272/2008.