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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 218-076-0 | CAS number: 2049-95-8
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 29 December 2009 - 20 January 2010 (in-life phase)
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Recent GLP and 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:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- tert-pentylbenzene
- EC Number:
- 218-076-0
- EC Name:
- tert-pentylbenzene
- Cas Number:
- 2049-95-8
- Molecular formula:
- C11H16
- IUPAC Name:
- (2-methylbutan-2-yl)benzene
- Details on test material:
- Batch number: BV1114
Expiry date: 31 December 2010
Purity: 98.2 %
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Young adult animals (approx. 9 weeks old) were selected. Body weight variation did not exceed +/- 20% of the sex mean.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- - Method: Oral gavage, using plastic feeding tubes.
- Fasting: Animals were deprived of food overnight prior to dosing and until 3-4 hours after administration of the test substance. Water was available.
- Frequency: Single dosage, on Day 1. - Doses:
- 2000 mg/kg (2.051 mL/kg) body weight.
- No. of animals per sex per dose:
- 6
- Control animals:
- no
- Details on study design:
- Tertiary-amylbenzene was administered by oral gavage to two subsequent groups of three female Wistar rats at 2000 mg/kg body weight. Animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed after terminal sacrifice (Day 15).
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred.
- Clinical signs:
- other: On Day 1, uncoordinated movements, piloerection and/or salivation was seen among the animals. Rales and tremors were displayed by one animal. Hunched posture was noted in all animals on Days 1 and 2.
- Gross pathology:
- No abnormalities were found at macroscopic post mortem examination of the animals.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the test conditions of this study, the oral LD50 value of tertiary-amylbenzene in Wistar rats was established to exceed 2000 mg/kg body weight. Therefore, no classification is required according to EU criteria.
- Executive summary:
The acute oral toxicity of tertiary-amylbenzene for rats was determined according to the Acute Toxic Class Method.
The study was carried out based on the guidelines described in:
- OECD No.423 (2001) "Acute Oral Toxicity, Acute Toxic Class Method"
- Commission Regulation (EC) No 440/2008, B1 tris: "Acute Oral Toxicity, Acute Toxic Class Method"
- EPA, OPPTS 870.1100 (2002), "Acute Oral Toxicity"
- JMAFF guidelines (2000) including the most recent partial revisions.
Tertiary-amylbenzene was administered by oral gavage to two subsequent groups of three female Wistar rats at 2000 mg/kg body weight. Animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed after terminal sacrifice (Day 15).
No mortality occurred. On Day 1, uncoordinated movements, piloerection and/or salivation was seen among the animals. Rales and tremors were displayed by one animal. Hunched posture was noted in all animals on Days 1 and 2. The body weight gain shown by the animals over the study period was considered to be normal. No abnormalities were found at macroscopic post mortem examination of the animals.
The oral LD50 value of Tertiary-amylbenzene in Wistar rats was established to exceed 2000 mg/kg body weight. According to the OECD 423 test guideline and considering the clinical signs noted, the LD50 cut-off value was considered to be 5000 mg/kg body weight. Based on these results, no classification is required according to EU criteria.
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.
