Registration Dossier
Registration Dossier
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EC number: 205-550-7 | CAS number: 142-62-1
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
- Study period:
- 14 Jan - 5 Feb 1999
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- GLP-Guideline study tested with the source substance CAS 111-20-6. In accordance to the ECHA guidance document "Practical guide 6: How to report read-across and categories (March 2010)", the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Sebacic acid
- EC Number:
- 203-845-5
- EC Name:
- Sebacic acid
- Cas Number:
- 111-20-6
- Molecular formula:
- C10H18O4
- IUPAC Name:
- sebacic acid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Crl:CD(SD)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Italia S.p.A., Calco, Italy
- Age at study initiation: max. 3 months
- Weight at study initiation: males: 290-350 g; females: 247-286 g
- Housing: 5 animals/sex in grill cages (40.5 x 38.5 x 18 cm) with stainless steel feeder
- Diet: GLP 4RF21 top certificate pelleted diet (Mucedola S.r.l., Settimo Milanese, Italy), ad libitum
- Water: filtered municipal water, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 55 ± 10
- Air changes (per hr): 15-20
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 14 Jan 1999 To: 29 Jan 1999 (males); From: 21 Jan 1999 To: 5 Feb 1999 (females)
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: clipped skin of the dorsal surface (6x5 cm²)
- % coverage: 10
- Type of wrap if used: The test material was held in contact with the skin with a porous gauze dressing fixed to the skin with hypoallergenic non-irritating tape. The site was further covered in a suitable manner in order to ensure that the animals could not ingest the test substance.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Residual test substance was removed with water.
- Time after start of exposure: 24 h
TEST MATERIAL
- The test material was applied uniformely onto a porous gauze which was moistened with 0.9% NaCl solution. - Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed at 30 minutes, 2, 4 and 6 h on the first day after administration (day 1) and then twice daily until the end of the observation period. Weighing was done before administration of the test substance and on days 8 and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred during the study period.
- Clinical signs:
- other: No general or local abnormalities were observed up to the end of the 14-day observation period.
- Gross pathology:
- Necropsy revealed no appreciable changes.
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria are not met, no classification required according to Regulations (EC) No 1272/2008.
- Conclusions:
- CLP: not classified
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