Registration Dossier
Registration Dossier
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EC number: 211-746-3 | CAS number: 693-23-2
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1989-02-21 to 1989-03-07
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- 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 of Hüls AG, purity ca. 99 %; impurities: homologous dicarboxylic acids, total 1 %
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ORGANISMS:
- Strain: Bor: WISW (SPF TNO)
- Source: F. Winkelmann, Borchen (Germany)
- Weight at study initiation: total mean 113 g
- Controls: no
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- ADMINISTRATION:
- Preparation of test substance: grinding in mortar, suspension in corn oil (30 %) with ultra turrax
- Doses per time period: single dose (gavage)
- Volume administered or concentration: 10 ml/kg bw
- Post dose observation period: 14 days - Doses:
- 3000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- EXAMINATIONS:
- Body weights: before, and 1, 7, 14 days after treatment
- Clinical signs and mortality: within 6 hours after treatment, thereafter daily
- Necropsy: all animals (macroscopic)
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 3 000 mg/kg bw
- Mortality:
- MORTALITY: No deaths occurred
- Clinical signs:
- other: CLINICAL SIGNS: - 30 minutes after treatment: piloerection and slight sedation in all animals - 2 hours after treatment: no more sedation - 3 hours after treatment: no more signs of toxicity
- Gross pathology:
- NECROPSY FINDINGS: No evidence of macroscopically discernible organ changes was found.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: other: EC Regulation 1272/2008
- Executive summary:
In a acute oral limit test according to TG OECD 401 five rat per sex received a dose of 3000 mg/kg bw. There were no mortalities and no adverse effects other than initial slight sedation and piloerection which subsided after two hours.
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