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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
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EC number: 907-237-7 | CAS number: -
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:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 707 µg/cm²
- Most sensitive endpoint:
- sensitisation (skin)
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 3
- Dose descriptor:
- other: NOAEC 2121.0 µg/cm²
- AF for dose response relationship:
- 1
- Justification:
- As the NOAEC was taken as the dose descriptor starting point no (additional) assessment factor is needed (ECHA’s guidance, R.8.4.3.1, November, 2012).
- AF for differences in duration of exposure:
- 1
- Justification:
- Repeated exposure is taken into account in the exposure assessment by using events/day.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- An assessment factor for allometric scaling is not needed since local effects are independent of the basal metabolic rate, allometric scaling should not be applied (allometric scaling factor of 1) ECHA, 2012, Chapter R8.
- AF for other interspecies differences:
- 1
- Justification:
- The assessment factor for remaining uncertainties can be 1. For vehicle effects: an assessment factor of 1 is applied as the matrices of the substance are not intended to enhance penetration. For type of skin (skin thickness and skin integrity) it can be seen that the human skin (exposed hands) to be similarly or less sensitive compared to the skin of the mouse ear. The LLNA is selected as a model because the mouse ear is considered very thin with high blood flow and as such reflect a similar thickness and integrity compared to human skin in general.
- AF for intraspecies differences:
- 3
- Justification:
- ECETOC TR No. 110 (2010) The intraspecies variation in humans is greater than that in the more homogenous experimental animal population. Based on an evaluation of the scientific literature by ECETOC, an AF of 3 (for workers) and of 5 (for the general population is advised, after a detailed review of the literature.
- AF for the quality of the whole database:
- 1
- Justification:
- An assessment factor of 1 is applicable because the information fulfils the REACH requirements: a LLNA study according to OECD guideline was used.
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties were 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:
- 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:
- DNEL (Derived No Effect Level)
- Value:
- 424 µg/cm²
- Most sensitive endpoint:
- sensitisation (skin)
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 5
- Dose descriptor:
- other: NOAEC 2121 µg/cm²
- AF for dose response relationship:
- 1
- Justification:
- As the NOAEC was taken as the dose descriptor starting point no (additional) assessment factor is needed (ECHA’s guidance, R.8.4.3.1, November, 2012).
- AF for differences in duration of exposure:
- 1
- Justification:
- Repeated exposure is taken into account in the exposure assessment by using events/day.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- An assessment factor for allometric scaling is not needed since local effects are independent of the basal metabolic rate, allometric scaling should not be applied (allometric scaling factor of 1) ECHA, 2012, Chapter R8.
- AF for other interspecies differences:
- 1
- Justification:
- The assessment factor for remaining uncertainties can be 1. For vehicle effects: an assessment factor of 1 is applied as the matrices of the substance are not intended to enhance penetration. For type of skin (skin thickness and skin integrity) it can be seen that the human skin (exposed hands) to be similarly or less sensitive compared to the skin of the mouse ear. The LLNA is selected as a model because the mouse ear is considered very thin with high blood flow and as such reflect a similar thickness and integrity compared to human skin in general.
- AF for intraspecies differences:
- 5
- Justification:
- The intraspecies variation in humans is greater than that in the more homogenous experimental animal population. Based on an evaluation of the scientific literature by ECETOC, an AF of 3 (for workers) and of 5 (for the general population is advised, after a detailed review of the literature.
- AF for the quality of the whole database:
- 1
- Justification:
- An assessment factor of 1 is applicable because the information fulfils the REACH requirements: a LLNA study according to OECD guideline was used.
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties were 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
Sensitisation reference: Bloemen K., Verstraelen S., Schoeters G., Legiest B., Nemery B., 2009, The collection and evaluation of data on incidence and severity of skin and respiratory allergy related to exposure of chemicals from non-food sources. Annex VI, 2009/MRG/R/308. Study carried out for European Commission Health & Consumer Protection Directorate-General Directorate C – Public health and Risk Assessment Unit C – Risk Assessment
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.
