Registration Dossier
Registration Dossier
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EC number: 211-746-3 | CAS number: 693-23-2
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: Study well documented, meets generally accepted scientific principles, acceptable for assessment, however only summary available, no GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 980
- Report date:
- 1980
Materials and methods
- Principles of method if other than guideline:
- see Test Conditions
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Dodecanedioic acid
- EC Number:
- 211-746-3
- EC Name:
- Dodecanedioic acid
- Cas Number:
- 693-23-2
- Molecular formula:
- C12H22O4
- IUPAC Name:
- dodecanedioic acid
- Details on test material:
- Dodecanedioic acid, purity 100 %
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: albino rabbits
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ORGANISMS:
- Strain: unspecified albino
- Weight at study initiation: 2.9-3.2 kg, mean 2.959 kg
- Controls: no
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- ADMINISTRATION:
- Area covered: trunk area (back) clipped free of hair; plastic collars
- Preparation of test substance: moistened with physiological saline
- Occlusion: Three 3" x 3" 12 ply gauze pads; under wrap plus gauze bandage; fixed with adhesive bandage
- Removal of test substance: 24 hours after administration washing with water and drying - Duration of exposure:
- 24 hours
- Doses:
- 6000 mg/kg bw
- No. of animals per sex per dose:
- 6
- Control animals:
- not specified
- Details on study design:
- EXAMINATIONS: 14-day recovery period
OTHER: The dose was based on a range finding study with 1 rabbit each dosed 5000 or 7500 mg/kg bw. There was difficulty adhering
7500 mg/kg bw to the rabbit's back. Both rabbits survived.
Results and discussion
Effect levels
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 6 000 mg/kg bw
- Mortality:
- MORTALITY: No animal died during the study
- Clinical signs:
- other: CLINICAL SIGNS: slight skin irritation, diarrhea and nasal discharge. Two rabbits had weight loss on the day after dosing and there was sporadic weight loss 3-13 days after dosing. .
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: other: EC Regulation 1272/2008
- Conclusions:
- no classification regarding acute dermal toxicity required
- Executive summary:
In a limit test on dermal toxicity six male albino rabbits received a dose of 6000 mg/kg bw applied to the back skin for 24 hours. No mortalities occurred and observed effects included slight skin irritation, diarrhea, nasal discharge and sporadic weight loss.
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