Registration Dossier
Registration Dossier
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EC number: 272-599-9 | CAS number: 68892-13-7
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1 mg/kg bw/day
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 100
- Dose descriptor starting point:
- NOAEL
- Value:
- 100 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
No modification of the dose descriptor is applied. In the absence of toxicokinetics data, the dermal absorption is considered to be 100% and therefore the NOAEL dermal is assumed to be equivalent to the NOAEL oral.
- AF for dose response relationship:
- 1
- Justification:
- NOAEL as starting point
- AF for differences in duration of exposure:
- 1
- Justification:
- No correction is applied for the duration of exposure since the animals were exposed thoughout the gestation period which would be also the case for women in contact with the substance in the worse case situation.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default value from rat to human
- AF for other interspecies differences:
- 2.5
- Justification:
- Defaut value recommended by ECHA (guidance R8)
- AF for intraspecies differences:
- 5
- Justification:
- Defaut value recommended by ECHA for worker (guidance R8)
- AF for the quality of the whole database:
- 2
- Justification:
- Factor recommended by ECHA for Reproduction/Developmental Toxicity Screening Test to take account of the lower sensitivity of the study.
- AF for remaining uncertainties:
- 1
- Justification:
- study fully compliant with OECD guideline and GLP
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
- Route of original study:
- Dermal
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
The substance is classified as Category 1B skin sensitizer and thus falls in the moderate hazard band according to the Guidance on information requirements and chemical safety assessment (Part E). Handling of such substances should be well-controlled in order to avoid dermal contact and inhalation exposure.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.5 mg/kg bw/day
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 200
- Dose descriptor starting point:
- NOAEL
- Value:
- 100 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
No modification of the dose descriptor is applied. In the absence of toxicokinetics data, the dermal absorption is considered to be 100% and therefore the NOAEL dermal is assumed to be equivalent to the NOAEL oral.
- AF for dose response relationship:
- 1
- Justification:
- NOAEL as starting point
- AF for differences in duration of exposure:
- 1
- Justification:
- No correction is applied for the duration of exposure since the animals were exposed thoughout the gestation period which would be also the case for women in contact with the substance in the worse case situation.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default value from rat to human
- AF for other interspecies differences:
- 2.5
- Justification:
- Defaut value recommended by ECHA (guidance R8)
- AF for intraspecies differences:
- 10
- Justification:
- Defaut value recommended by ECHA for consumer (guidance R8)
- AF for the quality of the whole database:
- 2
- Justification:
- Factor recommended by ECHA for Reproduction/Developmental Toxicity Screening Test to take account of the lower sensitivity of the study.
- AF for remaining uncertainties:
- 1
- Justification:
- study fully compliant with OECD guideline and GLP
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
- Route of original study:
- Dermal
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Oral
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.
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.
