Registration Dossier

Administrative data

Description of key information

In conclusion, the test substance IPPD showed a practically non-irritating potential to rabbit skin (Monsanto Co. 1974). This finding is supported by earlier studies with human volunteers (Bayer AG 1963). A rather slight and transient eye irritation potential is noted in an eye irritation study (Monsanto Co. 1974). 

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

Skin

Non-human information

The skin irritation potential of the test substance IPPD was evaluated in a skin irritation study with six New Zealand Albino rabbits (Monsanto Co.1974). The test substance (0.5 g) was applied as finely ground powder moistened with water under semi-occlusive dressings to clipped intact and abraded skin of 6 New Zealand albino rabbits for 24 hours. A 7-day observation period followed the test substance application. The test substance IPPD was practically non-irritating to rabbit skin (mean irritation score intact and abraded skin: 0).

Human information

In an early and limited documented study the skin irritating effect of IPPD was evaluated with human volunteers. Test material purchased from different companies was applied on the forearm of six male volunteers for four hours (Bayer AG 1963). The tested material was either slightly or not irritating to human skin.

Eye

Non-human information

The eye irritating potential of the test substance IPPD was evaluated in an eye irritation study with six New Zealand albino rabbits (Monsanto Co 1974). The finely ground test substance (100 mg) was placed into eyes of six rabbits. A 7-day observation period followed the application of the test substance. Eye response were scored in accordance with the Federal Hazardous substances Act (F.H.S.A.), 21 CFR, § 191.12 (1964). The test substance was very slightly irritating to the rabbit eye (irritation score 24, 48, and 72 hours: 1.3/110.0). Effects on the conjunctivae were noted in all animals at 24 hours (mean score 24 h: 4.0/110) but were reversible within 48 hours. The test substance was not classified as eye irritating.

Justification for classification or non-classification

No classification is required according to regulation no. 1272/2008 (GHS).