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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 293-316-5 | CAS number: 91053-50-8
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 11.75 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 150
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 1 763 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Step 1) Relevant dose-descriptor; Value: 1000 mg/kg bw/day (NOAEL); Remark: This is the concentration where no significant adverse effects were seen in a sub-chronic oral toxicity study.
Step 2) Modification of starting point for rat respiratory volume (Allometric scaling); Value: 0.38 m3/kg bw (rat 8-hour respiratory volume); Remark: A modification of starting point for rat respiratory volume was applied per REACH guidance R.8.4.2.
Step 3) Modification of starting point for differences in respiratory volumes;Value: 0.67 (6.7 m3/10 m3); Remark: A modification was applied to account for the increased respiratory volumes in active workers as compared to individuals at rest per REACH guidance R.8.4.2.
- AF for dose response relationship:
- 1
- Justification:
- A factor of 1 is appropriate since the dose descriptor is a NOAEL.
- AF for differences in duration of exposure:
- 6
- Justification:
- This is a default assessment factor for a sub-acute study per REACH Guidance R.8.4.3.1.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- A factor of 1 is appropriate since the adjusted start point was via mg/m3(inhalation) and thus this assessment factor is not applicable per REACH guidance R.8.4.3.1.
- AF for other interspecies differences:
- 2.5
- Justification:
- A default factor of 2.5 is appropriate per REACH guidance R.8.4.3.1.
- AF for intraspecies differences:
- 5
- Justification:
- This is a default assessment factor for workers per REACH Guidance R.8.4.3.1.
- AF for the quality of the whole database:
- 1
- Justification:
- A high quality, robust toxicity database exists for this substance.
- AF for remaining uncertainties:
- 2
- Justification:
- A factor of 2 is appropriate per REACH guidance R.8.4.2 (oral to inhalation).
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:
- 3.33 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 300
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
This is the concentration where no significant adverse effects were seen in a repeated dose oral toxicity study.
- AF for dose response relationship:
- 1
- Justification:
- A factor of 1 is appropriate since the dose descriptor is a NOAEL.
- AF for differences in duration of exposure:
- 6
- Justification:
- This is a default assessment factor for a sub-acute study per REACH Guidance R.8.4.3.1.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- A factor of 4 is appropriate since the adjusted start point was via mg/kg per REACH guidance 8.4.3.1.
- AF for other interspecies differences:
- 2.5
- Justification:
- A default factor of 2.5 is appropriate per REACH guidance R.8.4.3.1.
- AF for intraspecies differences:
- 5
- Justification:
- This is a default assessment factor for workers per REACH Guidance R.8.4.3.1.
- AF for the quality of the whole database:
- 1
- Justification:
- A high quality, robust toxicity database exists for this substance.
- AF for remaining uncertainties:
- 1
- Justification:
- A factor of 1 is appropriate since the animal exposure was via ingestion per REACH guidance 8.4.2.
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:
- 75 µg/cm²
- Most sensitive endpoint:
- sensitisation (skin)
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 150
- Dose descriptor starting point:
- other: EC3
- AF for dose response relationship:
- 3
- Justification:
- A factor of 3 is appropriate as an EC3 value can be considered as a LOAEL for induction of skin sensitization per REACH R.8 Appendix R.8-10.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- A factor of 1 is appropriate since local effects are independent of the basal metabolic rate, and the adjusted start point was via µg/cm2(dermal) and thus this assessment factor is not applicable per REACH guidance R.8.4.3.1.
- AF for other interspecies differences:
- 10
- Justification:
- A default factor of 10 is appropriate per REACH guidance 8.4.3 and Appendix R8-10.
- AF for intraspecies differences:
- 5
- Justification:
- This is a default assessment factor for workers per REACH Guidance R.8.4.3.1.
- AF for the quality of the whole database:
- 1
- Justification:
- A high quality, robust toxicity database exists for this substance.
- AF for remaining uncertainties:
- 1
- Justification:
- A factor of 1 is appropriate since the animal exposure was via the dermal route per REACH guidance 8.4.2.
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
Potential worker exposure would
likely occur via the dermal or inhalation routes.
Based on the rat acute oral and
dermal LD50 values of >5000 mg/kg and the
4-hour LC50 in rats of >0.89 mg/L (the
maximum practically attainable atmospheric aerosol concentration), this
substance is not classified for acute toxicity via the oral, dermal, or
inhalation routes under REACH regulations and guidance.
Male and female rats were exposed
to the test substance daily via gavage in an OECD 422 study (oral
toxicity with one generation reproduction screening study) at doses of
100, 300, and 1000 mg/kg. No evidence of systemic
toxicity was observed at the highest dose tested, therefore the NOAEL
was 1000 mg/kg.
Although the weight of evidence
suggests that this test substance is not a skin sensitizer, and the
substance is not classified as a skin sensitizer, effects were produced
in an acute exposure LLNA study; therefore a short-term DNEL for local
effects by the dermal route was derived.
In a local lymph node assay, this
substance was found to be positive for dermal sensitization with an EC3
value of 45% (11250 µg/cm2). As per REACH R.8 Appendix
R. 8-10 Skin sensitization, an EC3 value can be considered as a LOAEL
for induction (expressed in µg/cm2) and can be used for
development of a short-term DNEL for local effects.
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:
- DNEL (Derived No Effect Level)
- Value:
- 1.67 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 600
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
This is the concentration where no significant adverse effects were seen in a repeated-dose oral toxicity study.
- AF for dose response relationship:
- 1
- Justification:
- A factor of 1 is appropriate since the dose descriptor is a NOAEL.
- AF for differences in duration of exposure:
- 6
- Justification:
- This is a default assessment factor for a sub-acute study per REACH Guidance R.8.4.3.1.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- A factor of 4 is appropriate since the adjusted start point was via mg/kg per REACH guidance 8.4.3.1.
- AF for other interspecies differences:
- 2.5
- Justification:
- A default factor of 2.5 is appropriate per REACH guidance R.8.4.3.1.
- AF for intraspecies differences:
- 10
- Justification:
- This is a default assessment factor for the general population per REACH Guidance R.8.4.3.1.
- AF for the quality of the whole database:
- 1
- Justification:
- A high quality, robust toxicity database exists for this substance.
- AF for remaining uncertainties:
- 1
- Justification:
- A factor of 1 is appropriate since the animal exposure was via ingestion per REACH guidance 8.4.2.
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:
- 38 µg/cm²
- Most sensitive endpoint:
- sensitisation (skin)
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 300
- Dose descriptor starting point:
- other: EC3
- AF for dose response relationship:
- 3
- Justification:
- A factor of 3 is appropriate as an EC3 value can be considered as a LOAEL for induction of skin sensitization per REACH R.8 Appendix R.8-10.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- A factor of 1 is appropriate since local effects are independent of the basal metabolic rate, and the adjusted start point was via µg/cm2 (dermal). Thus this assessment factor is not applicable per REACH guidance R.8.4.3.1.
- AF for other interspecies differences:
- 10
- Justification:
- A default factor of 10 is appropriate per REACH guidance 8.4.3 and Appendix R.8-10.
- AF for intraspecies differences:
- 10
- Justification:
- This is a default assessment factor for the general population per REACH Guidance R.8.4.3.1
- AF for the quality of the whole database:
- 1
- Justification:
- A high quality, robust toxicity database exists for this substance.
- AF for remaining uncertainties:
- 1
- Justification:
- A factor of 1 is appropriate since the animal exposure was via the dermal route per REACH guidance 8.4.2.
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
Potential general population
exposure would likely occur via the dermal route.
Based on the rat acute oral and
dermal LD50 values of >5000 mg/kg and the
4-hour LC50 in rats of >0.89 mg/L (the maximum practically
attainable atmospheric aerosol concentration), this substance is not
classified for acute toxicity via the oral, dermal, or inhalation routes
under REACH regulations and guidance.
Male and female rats were exposed
to the test substance daily via gavage in an OECD 422 study (oral
toxicity with one generation reproduction screening study) at doses of
100, 300, and 1000 mg/kg. No evidence of systemic
toxicity was observed at the highest dose tested, therefore the NOAEL
was 1000 mg/kg.
Although the weight of evidence
suggests that this test substance is not a skin sensitizer, and the
substance is not classified as a skin sensitizer, effects were produced
in an acute exposure LLNA study; therefore a short-term DNEL for local
effects by the dermal route was derived.
In a local lymph node assay, this substance was found to be positive for dermal sensitization with an EC3 value of 45% (11250 µg/cm2). As per REACH R.8 Appendix R. 8-10 Skin sensitization, an EC3 value can be considered as a LOAEL for induction (expressed in µg/cm2) and can be used for development of a short-term DNEL for local effects.
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.
