Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 203-095-9 | CAS number: 103-28-6
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Data is from peer-reviewed journal
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Acute dermal toxicity of test chemical in rabbits
- Author:
- D.L.J.Opdyke
- Year:
- 1 973
- Bibliographic source:
- Food and Cosmetics Toxicology, 1973
- Reference Type:
- publication
- Title:
- Acute dermal toxicity of test chemical in rabbits
- Author:
- D. Belsito et. al.
- Year:
- 2 012
- Bibliographic source:
- Food and Chemical Toxicology ,2012
- Reference Type:
- publication
- Title:
- Acute dermal toxicity of test chemical in rabbits
- Author:
- D. McGinty et. al.
- Year:
- 2 012
- Bibliographic source:
- Food and Chemical Toxicology,2012
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Principles of method if other than guideline:
- Acute dermal toxicity of test chemical was determined in rabbits.
- GLP compliance:
- not specified
- Test type:
- other: No data
- Limit test:
- yes
Test material
- Reference substance name:
- Benzyl isobutyrate
- EC Number:
- 203-095-9
- EC Name:
- Benzyl isobutyrate
- Cas Number:
- 103-28-6
- Molecular formula:
- C11H14O2
- IUPAC Name:
- benzyl 2-methylpropanoate
- Test material form:
- other: Liquid
- Details on test material:
- - Name of test material (as cited in study report): Benzyl isobutyrate
- Molecular formula (if other than submission substance): C11H14O2
- Molecular weight (if other than submission substance): 178.23 g/mole
- Substance type: Organic
- Physical state: Liquid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- not specified
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- No data available
Administration / exposure
- Type of coverage:
- not specified
- Vehicle:
- not specified
- Details on dermal exposure:
- TEST SITE
- Area of exposure: intact and abraded sites - Duration of exposure:
- No data available
- Doses:
- 5000 mg/kg
- No. of animals per sex per dose:
- 2 male ,2 female
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:No
- Necropsy of survivors performed:Yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: Gross pathology were examined. - Statistics:
- No data available
Results and discussion
- Preliminary study:
- No data available
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: No effect on gross pathology and gross pathology
- Mortality:
- No effect on survival of treated rabbits were observed at 5000 mg/kg bw.
- Clinical signs:
- other: Slight to moderate erythema that resolved by day eight was seen at intact and abraded sites of all animals. Edema was not observed.
- Gross pathology:
- No gross pathological changes were observed in treated male and female rabbits.
- Other findings:
- No data available
Any other information on results incl. tables
Summary of acute toxicity studies
Route |
Species |
NO. animals/dose group |
LD50 (g/kg) |
Dermal |
Rabbit |
4 |
>5.0 |
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified
- Conclusions:
- The LD50 value was considered to be >5000 mg/kg bw,when 2 male and female rabbits were treated with test chemical by dermal application following 14 days of observation period.
- Executive summary:
In acute dermal toxicity study, 2 male and female rabbits were treated withtest chemicalin the concentration of 5000 mg/kg bw which was applied on intact and abraded sites of skin.No mortality was observed in treated rabbits at dose 5000 mg/kg bw.Slight to moderate erythema that resolved by day eight was seen at intact and abraded sites of all animals. Edema was not observed.No effect on survival of treated rabbits were observed at 5000 mg/kg bw and No gross pathological changes were observed in treated male and female rabbits.Therefore, LD50 value was considered to be >5000 mg/kg bw,when rabbits were treated with test chemical by dermal application.
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.
