Registration Dossier

Diss Factsheets

Administrative data

Description of key information

Acute oral toxicity:

LD50(rat): > 5000 mg/kg bw /day (OECD 401, limit test).

Acute dermal toxicity:

LD50(rabbit): >2000mg/kg bw /day (16 CFR 1500).

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Dose descriptor:
LD50
Value:
5 000 mg/kg bw

Acute toxicity: via dermal route

Endpoint conclusion
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Additional information

Acute oral toxicity

The acute oral toxicity was evaluated in a well conducted GLP and OECD guideline 401 study (limit study) with Sprague-Dawley Albino rats.10 rats (5 male rats and 5 female rats) were administrated at dose of 5000mg/kg bw/day. All animals survived. Signs seen on the day of dosing in a few animals included wet rales and soft stool. A few animals had decreased food consumption on the day of dosing; this continued in some animals through Day 2. One male had swollen nose on Days 3 and 4. All surviving animals were free of significant abnormalities from Day 3 through termination of the study. The LD50(rat) > 5000mg/kg bw/day was established in this study.(1995) 

Acute dermal toxicity

The acute dermal toxicity was evaluated in a key study according to 16 CFR 1500 with albino new Zealand white rabbits. 10 rabbits (6 male rabbits and 4 female rabbits) were administrated at dose of 2000 mg/kg bw/day. Only one male rabbit died on day 4 of the study. Most animals were free of significant signs of systemic toxicity on the day of dosing. LD50(rabbit)>2000kg/kg bw/day was established in this study.(1995)

 

Justification for classification or non-classification

Based on the available information in the dossier, the substance Chiguard 380/Chiguard 380W (CAS# 18600-59-4) does not need to be classified for acute toxicity when considering the criteria outlined in Annex I of 1272/2008/EC and Annex VI of 67/548/EEC.