Registration Dossier
Registration Dossier
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EC number: 916-533-5 | CAS number: -
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- insufficient hazard data available (further information necessary)
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- insufficient hazard data available (further information necessary)
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
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Additional information - workers
The substance is not acutely toxic following oral administration or dermal application and therefore acute DNELs for systemic effects are not required. The substance was not irritating to the skin and did not show any sensitising potential therefore DNELs for local effects on skin are not required. The substance is irritating to eye and could be considered to be irritating also to the mucous membranes of the respiratory system; although inhalation DNELs for local effects (acute and long-term) would be required, no data on dose response are available and therefore DNELs cannot be derived.
Based on the available studies used to support the registration, the substance is considered to not be genotoxic.
The key value to be used for DNEL derivation is likely to be obtained from the OECD 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test) study. However, the study report was provided by the testing laboratory very close to the registration deadline and the content is still under discussion. As such, it is currently not possible to set DNELs for this substance. This issue will be revisited once the key values are finalised and a registration update containing the DNEL values will be submitted as soon as possible.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- insufficient hazard data available (further information necessary)
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- insufficient hazard data available (further information necessary)
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:
- insufficient hazard data available (further information necessary)
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Additional information - General Population
The substance is not acutely toxic following oral administration or dermal application and therefore acute DNELs for systemic effects are not required. The substance was not irritating to the skin and did not show any sensitising potential therefore DNELs for local effects on skin are not required. The substance is irritating to eye and could be considered to be irritating also to the mucous membranes of the respiratory system; although inhalation DNELs for local effects (acute and long-term) would be required, no data on dose response are available and therefore DNELs cannot be derived.
Based on the available studies used to support the registration, the substance is considered to not be genotoxic.
The key value to be used for DNEL derivation is likely to be obtained from the OECD 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test) study. However, the study report was provided by the testing laboratory very close to the registration deadline and the content is still under discussion. As such, it is currently not possible to set DNELs for this substance. This issue will be revisited once the key values are finalised and a registration update containing the DNEL values will be submitted as soon as possible.
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.
