Registration Dossier
Registration Dossier
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EC number: 218-076-0 | CAS number: 2049-95-8
Endpoint summary
Administrative data
Description of key information
The key study for this endpoint is a 28 days study in rat by oral administration (Reliability.1, GLP).
- The NOEL is 300 mg/kg bw/day for females based on the high values of TP and albumin, significant prolongation of APTT, high Ca value, mild centrilobular hypertrophy of hepatocytes in the liver and increased liver weight observed at 1000 mg/kg bw/day (these effects are not adverse and reversible after 14 days of recovery).
- The NOEL is 100 mg/kg bw/day for males based on the high values of TP, albumin and kidney weight at 300 mg/kg bw/day. In the 1000 mg/kg dose group, the male animals showed the low values of weight gain, rate of weight gain and Cl, high γ-GTP value and increased liver weight (these effects are not adverse and reversible after 14 days of recovery).
- The NOAEL is 300 mg/kg bw/day for male and female rats. The histopathological effects on kidneys, which were found for males at 300 mg/kg bw/day, are considered not relevant for humans. The accumulation of protein (hyaline) droplets in the kidney can also explain the increased absolute kidney weight of the males (12 %). The biochemical findings showed a statistically significant increase of total protein (TP) (4,6 %) and albumin (5,1 %) for the male rats but this increase is not very high and was observed for male rats only.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 300 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- Guideline and GLP study (Reliability.1).
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
Based on the results of the key study (OECD 407, Reliability 1, GLP), the NOEL is 300 mg/kg bw/day for female and 100 mg/kg bw/day for male rats. No adverse effects were observed, the NOAEL: 300 mg/kg bw/day was identified (expert judgment). Therefore, tert-pentylbenzene is not classified for repeat-dose toxicity 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.
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