Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: summary data

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
1983
Report Date:
1984

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Three female guinea pigs were utilized for this acute dermal toxicity study. Hair was clipped from the animals' back and the material was applied at a dosage of 1.0 g/kg to the entire back area under occlusion created by application oa a woven pat and a rubber dental dam over the application site. The material was left in contact with the skin for 24 hours, then washed off. Animals were assessed for skin irritation upon patch removel and for the next few days. Dermal toxicity and lethality were assessed by recording any clinical signs which subsequently evolved over a period of 10 days. As with the oral studies, weight loss was considered a sign of toxicity and an indication of absorption of the test chemical.
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
solid moistened with water

Test animals

Species:
guinea pig
Sex:
female

Administration / exposure

Type of coverage:
occlusive
Vehicle:
water
Duration of exposure:
2 weeks
Doses:
1.0 g/kg
No. of animals per sex per dose:
3
Control animals:
no
Details on study design:
material applied under rubber dan cuff

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 1 000 mg/kg bw
Based on:
test mat.
Body weight:
weight gain in 1 of 3 animals at week 1 and 2 of 3 animals at week 2

Applicant's summary and conclusion

Conclusions:
slight skin irritation at 24/48 hours; no mortality at 2 weeks after treatment; dermal LD50 > 1 g/kg; no evidence of percutaneous absorption
Executive summary:

After a 24 -hour exposure to the test article (1,4 - cyclohexane dicarboxylic acid; CHDA) at a concentration of 1 g/kg, there was slight skin irritation observed during the following 24 hour observation period. For up to 2 weeks following a 24 -hour exposure, there was no mortality and no evidence of percutaneous absorption. From these studies, it was concluded that the dermal LD50 was greater than 1 g/kg.