Registration Dossier
Registration Dossier
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EC number: 214-068-6 | CAS number: 1076-97-7
Acute Toxicity: dermal
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:
- 1 983
- 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 substance name:
- Cyclohexane-1,4-dicarboxylic acid
- EC Number:
- 214-068-6
- EC Name:
- Cyclohexane-1,4-dicarboxylic acid
- Cas Number:
- 1076-97-7
- Molecular formula:
- C8H12O4
- IUPAC Name:
- cyclohexane-1,4-dicarboxylic acid
- Details on test material:
- solid moistened with water
Constituent 1
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.
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.
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