Registration Dossier
Registration Dossier
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EC number: 211-185-4 | CAS number: 632-79-1
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.64 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Dose descriptor starting point:
- NOAEL
- Value:
- 94 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Explanation for the modification of the dose descriptor starting point:
TBPA has caused skin sensitization in the Buehler guinea pig test. Using the criteria in REACH Guidance R.8, Table R.8-24, TBPA would be considered "moderate". Quantiation of this endpoint for purposes of a DNEL was not attempted. Rather, the DNEL for inhalation was based on an oral 90-d study of tetrachlorophthalic anhydride in rats. The rat NOAEL in that study was 94 mg/kg bw administered by gavage, based on renal toxicity. Mice did not experience renal toxicity at any of the doses tested. This study was selected for derivation of the DNEL over the rat 21 d inhalation study due to the serious nature of the effects seen in rats in the 13 wk tetrachlorophthalic anhydride study and repeated dose studies by the dermal and oral routes of TBPA indicating similar effects. The NOAEL of 94 mg/kg bw was corrected to an inhalatory NOAEC by multiplying the NOAEL of 94 mg/kg by (1/0.38 m3/kg/d)(1/1)(6.7 m3 (8h)/10 m3 (8h) as indicated in the REACH Guidance Figure R.8-3. The corrected inhalatory NOAEC-worker = 166. Assessment factors were 2.5 for remaining species differences, 5 for worker intraspecies differences, 2 for subchronic to chronic, 1 for dose-response and quality of database. AF=25. The DNEL worker inhalation was calculated to be 0.64 mg/m3 This value is highly conservative.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 7 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- exposure based waiving
Acute/short term exposure
- Hazard assessment conclusion:
- exposure based waiving
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- exposure based waiving
Acute/short term exposure
- Hazard assessment conclusion:
- exposure based waiving
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- exposure based waiving
Acute/short term exposure
- Hazard assessment conclusion:
- exposure based waiving
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- exposure based waiving
Acute/short term exposure
- Hazard assessment conclusion:
- exposure based waiving
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- exposure based waiving
Acute/short term exposure
- Hazard assessment conclusion:
- exposure based waiving
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - General Population
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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