Registration Dossier
Registration Dossier
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EC number: 215-553-5 | CAS number: 1330-86-5
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study with acceptable restrictions. Limited details on experimental conditions and test animals. Insufficient number of test animals. Mixed genders at each dose level. Occlusive dressing was used.
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 972
- Report date:
- 1972
- Reference Type:
- secondary source
- Title:
- ECB IUCLID set dihexyl adipate
- Author:
- ECB
- Year:
- 2 000
- Bibliographic source:
- EUROPEAN COMMISION – European Chemicals Bureau
- Report date:
- 2000
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- yes
- Remarks:
- limited details on experimental conditions and test animals; insufficient number of test animals; mixed genders at each dose level; occlusive dressing was used
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- Dihexyl adipate
- EC Number:
- 203-757-7
- EC Name:
- Dihexyl adipate
- Cas Number:
- 110-33-8
- Molecular formula:
- C18H34O4
- IUPAC Name:
- dihexyl adipate
- Details on test material:
- - Name of test material (as cited in study report): Di-m-Hexyl adipate
- Physical state: liquid
- Analytical purity: no data
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 1.9 and 2.1 kg (males), 1.9 and 2.2 kg (females)
- Housing: Animals were housed individually during the observation period.
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: closely clipped area of the skin
- Type of wrap if used: The treated areas were covered with plastics strips and animals were held in wooden stocks during the exposure period. - Duration of exposure:
- up to 24 h
- Doses:
- 3160, 5010 and 7940 mg/kg bw
- No. of animals per sex per dose:
- 3160 mg/kg bw: 1 female
5010 mg/kg bw: 1 male
7940 mg/kg bw: 1 male and 1 female - Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 7 940 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred during the 14-day observation period.
- Clinical signs:
- other: Clinical signs involved reduced appetite and decreased activity 2 to 4 days after test substance application.
- Gross pathology:
- At necropsy, no macroscopic findings were observed in the viscera.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classified
DSD: not classified
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