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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 225-193-0 | CAS number: 4707-47-5
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:
- 2 500 µg/cm²
- Most sensitive endpoint:
- sensitisation (skin)
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 1
- Dose descriptor:
- NOAEC
- Value:
- 2 500 µg/m³
- AF for dose response relationship:
- 1
- Justification:
- Value is NOEC
- AF for differences in duration of exposure:
- 1
- Justification:
- No assessment factor as duration not relevant for skin sensitisation
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- No difference in metabolic rate has to be included for sensitisers as it is the parent substance which causes the sensitization.
- AF for other interspecies differences:
- 1
- Justification:
- No remaining differences
- AF for intraspecies differences:
- 1
- Justification:
- A reliable HRIPT test, carried out with 10% substance and using 100 subjects, can be used to adjust the AF for intraspecies differences because the healthy subjects in this test are similar susceptible compared to workers. In addition, the 10% concentration can be converted into a dose of 8000 ug/cm2 (0.2 ml on 25 mm2 human skin in a 10% solution) and exceeds the dose in the LLNA.
- AF for the quality of the whole database:
- 1
- Justification:
- Reliable studies used
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties
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
In deriving the DNELs for hazard identification for inhalation and the dermal route of exposure mostly ECHA's guidance is used, which is generally conservative by using default values in absence of data outside the requirements of REACH regulation Annex VII to Annex XI. In addition, the used assessment factors used have been adequately documented. For inter and intraspecies assessment factors have been used which were conducted to be scientifically sound by ECETOC (TR 110, 2010) and which are based on a thorough review of the scientific literature. Therefore the DNELs for all human health endpoints relevant for workers are considered sufficiently conservative to be used in risk characterization.
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:
- 1 250 µg/cm²
- Most sensitive endpoint:
- sensitisation (skin)
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 2
- Dose descriptor:
- NOAEC
- Value:
- 1 250 µg/m³
- AF for dose response relationship:
- 1
- Justification:
- In the LLNA test an EC3 of 19% and a NOEC of 10% is derived. The starting point for the DNEL derivation is this NOEC. The conversion from the NOEC to the ug/cm2 results in 2500 ug/cm2 (25ul on 1cm is 25000 ug/cm2*0.1 (fraction of the substance in the test solution).
- AF for differences in duration of exposure:
- 1
- Justification:
- No assessment factor as duration not relevant for skin sensitisation
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- No difference in metabolic rate has to be included for sensitisers as it is the parent substance which causes the sensitisation
- AF for other interspecies differences:
- 1
- Justification:
- No remaining differences
- AF for intraspecies differences:
- 2
- Justification:
- A reliable HRIPT test, carried out with 10% substance and using 100 subjects, can be used to adjust the AF for intraspecies differences because the healthy subjects in this test are similar susceptible compared to workers. In addition, the 10% concentration can be converted into a dose of 8000 ug/cm2 (0.2 ml on 25 mm2 human skin in a 10% solution) and exceeds the dose in the LLNA.
The general population is expected to be twice as sensitive as workers (ECHA guidance) and therefore a factor of two is used for intraspecies differences. - AF for the quality of the whole database:
- 1
- Justification:
- Reliable studies used
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties
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
In deriving the DNELs for hazard identification for inhalation, dermal route and oral exposure mostly ECHA's guidance is used, which is generally conservative by using default values in absence of data outside the requirements of REACH regulation Annex VII to Annex XI. In addition, the used assessment factors used have been adequately documented. For inter and intraspecies assessment factors have been used which were conducted to be scientifically sound by ECETOC (TR 110, 2010) and which are based on a thorough review of the scientific literature. Therefore the DNELs for all human health endpoints relevant for the general population are considered sufficiently conservative to be used in risk characterization.
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.
