Registration Dossier
Registration Dossier
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EC number: 262-634-6 | CAS number: 61167-58-6
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 13 Jan - 22 Mar 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- adopted in Oct 2017
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- 2-(1,1-dimethylethyl)-6-[[3-(1,1-dimethylethyl)-2-hydroxy-5-methylphenyl]methyl]-4-methylphenyl acrylate
- EC Number:
- 262-634-6
- EC Name:
- 2-(1,1-dimethylethyl)-6-[[3-(1,1-dimethylethyl)-2-hydroxy-5-methylphenyl]methyl]-4-methylphenyl acrylate
- Cas Number:
- 61167-58-6
- Molecular formula:
- C26H34O3
- IUPAC Name:
- 2-tert-butyl-6-[(3-tert-butyl-2-hydroxy-5-methylphenyl)methyl]-4-methylphenyl prop-2-enoate
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories Japan (Hino Breeding Center), Japan
- Age at study initiation: 7 weeks (males); 9 weeks (females)
- Weight at study initiation: 251.9 - 266.7 g (males); 209.8 - 224.6 g (females)
- Housing: animals were individually housed in stainless steel cages with mesh-floor (260W x 380D x 180H mm).
- Diet: pelleted diet (MF, lot No. 160915, Oriental Yeast), ad libitum
- Water: chorinated water (3 - 5 ppm by adding sodium hypochlorite to Hita City supply water), ad libitum
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 - 25
- Humidity (%): 40 - 70
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 13 Jan 2017 To: 22 Mar 2017
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- CMC (carboxymethyl cellulose)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: 5 x 5 cm clipped skin of the dorsal are of the trunk
- Type of wrap if used: The test material was held in contact with the skin with a non-woven gauze covered and fixed by elastic adhesive bandage
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The non-woven gauze and elastic adhesive bandage were removed and residual test substance was removed using purified water and absorbent cotton
- Time after start of exposure: 24 h
TEST MATERIAL
- Amount(s) applied: 10 mL/ kg bw
- Concentration: 20% (w/v)
- Constant volume or concentration used: yes - Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were observed for signs of toxicity or mortality continuously for 10 min after the application, and were observed once 30 min and 3 h after the application. Thereafter, the animals were observed once daily from 1 to 14 days after the application.
- Necropsy of survivors performed: yes, all animals were subjected to a gross necropsy 14 days after application
- Other examinations performed: body weights were recorded prior to the application, and on day 7 and 14 after the application.
Results and discussion
Effect levels
- Key result
- 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: 2000 mg/kg bw: slight decreased spontaneous locomotion was sporadically observed in all animals of both sexes from 5 min to 3 h after the application, and disappeared after removal of the non-woven gauze and elastic adhesive bandage on the next day of the
- Gross pathology:
- Necropsy and revealed no substance-related findings.
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation(EC) No. 1272/2008
- Conclusions:
- CLP: not classified
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