Registration Dossier
Registration Dossier
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EC number: 202-943-5 | CAS number: 101-43-9
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Cyclohexyl methacrylate
- EC Number:
- 202-943-5
- EC Name:
- Cyclohexyl methacrylate
- Cas Number:
- 101-43-9
- Molecular formula:
- C10H16O2
- IUPAC Name:
- cyclohexyl 2-methylprop-2-enoate
Constituent 1
- Specific details on test material used for the study:
- - Lot/batch No.: CHMA Verkaufstank 14 v.23.02.2010 PBG-Charge 010117eda0
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Wiga GmbH, Sulzfeld (Germany)
- Age at study initiation: young adult animals ( male animals approx. 8 weeks, female animals approx. 12 weeks)
- Weight at study initiation: animals of comparable weight ( +/- 20 % of the mean weight)
- Housing: single housing
- Diet: ad libitum ( VRF1(P); SDS Special Diets Services, Altrip, Germany)
- Water: ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: 40 cm²
- % coverage: 10 %
- Type of wrap if used: semi occlusive
REMOVAL OF TEST SUBSTANCE
- Washing: yes
- Time after start of exposure: 24 hours - Duration of exposure:
- 24 hours
- 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: weekly
- Other examinations performed: clinical signs
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.
- Clinical signs:
- other: Systemic effects: No systemic clinical signs were observed during clinical examination. Local effects: No local effects were observed.
- Gross pathology:
- No macrosopic pathologic abnomalities were noted in the animals (5 males and 5 females) examined on the last day of observation.
Any other information on results incl. tables
Mortality |
||
Dose (mg/kg bw): |
2000 |
2000 |
Sex: |
Male |
Female |
Administration: |
1 |
1 |
No. of animals: |
5 |
5 |
Mortality (animals): |
No mortality |
No mortality |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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