Registration Dossier
Registration Dossier
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EC number: 810-760-2 | CAS number: 149855-64-1
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:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
Test material
- Reference substance name:
- 2-propylheptyl methacrylate
- EC Number:
- 810-760-2
- Cas Number:
- 149855-64-1
- Molecular formula:
- C14 H26 O2
- IUPAC Name:
- 2-propylheptyl methacrylate
- Reference substance name:
- 2-Propylheptyl methacrylate
- IUPAC Name:
- 2-Propylheptyl methacrylate
- Details on test material:
- - Name of test material (as cited in study report): 2-propylheptyl methacrylate
- Physical state: liquid/ colorless, clear
- Analytical purity: 99.4 g/100g
- Lot/batch No.: S731900107
Constituent 1
Constituent 2
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
- Age at study initiation: male approx. 8 weeks; female approx. 12 weeks
- Weight at study initiation: animals of comparable weight (+/- 20%)
- Housing: single housing (Makrolon cage, type III)
- Diet (e.g. ad libitum): ad libitum (VRF1(P); SDS Special Diets Services, 67122 Altrip, Germany)
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days before
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 30 - 70
- Air changes (per hr): approx. 10
- 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 dressing (air-permeable dressing (4 layers of absorbent gauze (Ph. Eur.) and stretch bandage (Fixomull® Stretch (adhesive fleece)
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: after 24 hours, with warm water - Duration of exposure:
- 24 hours
- Doses:
- 5000 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
- Other examinations performed: clinical signs, body weight,pathology
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Mortality:
- No mortality occurred.
- Clinical signs:
- No signs of systemic toxicity or skin effects were observed.
- Body weight:
- The mean body weight of the animals increased within the normal range throughout the study period with two exceptions in the female group. One female lost weight and another one stagnated during the first week, but body weights were within the normal range during the second week.
- Gross pathology:
- No macroscopic pathologic abnormalities were noted in the animals examined at the end of the study.
Applicant's summary and conclusion
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
