Registration Dossier
Registration Dossier
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EC number: 806-509-1 | CAS number: 1393571-42-0
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
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:
- 3.3 mg/kg bw/day
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 300
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- NOAEL derived from oral study. Route-to-route extrapolation based on 10% absorption via the oral and dermal route.
- AF for dose response relationship:
- 1
- Justification:
- highest dose tested NOAEL
- AF for differences in duration of exposure:
- 6
- Justification:
- sub-acute to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- allometric scaling rat versus human
- AF for other interspecies differences:
- 2.5
- Justification:
- standard factor
- AF for intraspecies differences:
- 5
- Justification:
- worker exposure considered
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 1
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:
- DNEL (Derived No Effect Level)
- Value:
- 50 µg/cm²
- Most sensitive endpoint:
- sensitisation (skin)
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 15
- Dose descriptor starting point:
- other: EC3
- AF for dose response relationship:
- 3
- Justification:
- EC3 is considered to be a LOAEL for induction
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- local effect
- AF for other interspecies differences:
- 1
- Justification:
- local effect
- AF for intraspecies differences:
- 5
- Justification:
- extrapolation to workers
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 1
- Justification:
- potential influence of the matrix is limited
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
In view of the low volatility and the high viscosity of the test substance, the inhalation route is expected irrelevant for exposure. Route to route extrapolation from the oral study is performed to the systemic dermal DNEL. This DNEL is expected to protect workers for short exposure duration as well as for not identified long-term local effects.
The test substance is a skin sensitizer and protective measures will be taken based on classification and labelling. In addition a DNEL has been derived based on the EC3 from the LLNA test.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
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
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
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
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - General Population
No consumer exposure is anticipated. Therefore the consumer DNELs were not derived.
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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