Registration Dossier
Registration Dossier
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EC number: 247-987-6 | CAS number: 26762-92-5
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Effect on fertility: via oral route
- Endpoint conclusion:
- no study available
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Additional information
1)As the substance is used in industrial settings by professional users only, no oral exposure is expected. The dermal route is considered the most relevant route of exposure.
2) The critical effect found in repeated dose studies with structurally related chemicals is related to the corrosiveness of these substances. The test substance is corrosive as well and expected to exhibit local corrosive effects in the dose range of interest for the reproduction study. For reasons of animal welfare such studies should be avoided (Annex XI Section 2).
3)In addition the test substance is known to hydrolyse under acid conditions. These conditions will be fulfilled after oral application, but not after dermal or inhalation exposure, which will hamper the extrapolation from oral to other routes of exposure .
4) For local effects no route to route extrapolation can be applied.
Therefore the performance of a test with the oral route is considered not adequate to fulfil the requirements, while the test via dermal or inhalation exposure is not possible based on animal welfare/ethical reasons.
It is expected that the DNEL for local effects after single and repeated exposure will be sufficient to protect for any systemic effects including effects on the reproduction.
Justification for selection of Effect on fertility via oral route:
Waiver based on relevance of the oral exposure route for extrapolation to the relevant routes of occupational exposure (dermal (and inhalation))
Justification for selection of Effect on fertility via inhalation route:
waiver based on the local effects that are expected based on the corrosiveness of the test substance. For ethical reasons no repeated dose study should be performed.
Justification for selection of Effect on fertility via dermal route:
waiver based on the local effects that are expected based on the corrosiveness of the test substance. For ethical reasons no repeated dose study should be performed.
Effects on developmental toxicity
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via inhalation route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via dermal route
- Endpoint conclusion:
- no study available
Additional information
1)As the substance is used in industrial settings by professional users only, no oral exposure is expected. The dermal route is considered the most relevant route of exposure.
2) The critical effect found in repeated dose studies with structurally related chemicals is related to the corrosiveness of these substances. The test substance is corrosive as well and expected to exhibit local corosive effects in the dose range of interest for the developmental toxicity study. For reasons of animal welfare such studies should be avoided (Annex XI Section 2).
3)In addition the test substance is known to hydrolyse under acid conditions. These conditions will be fulfilled only after oral application, but not after dermal or inhalation exposure, which will hamper the extrapolation from the oral route to other routes of exposure .
4) For local effects no route to route extrapolation can be applied.
Therefore the performance of a test with the oral route is considered not adequate to fulfil the requirements, while the test via dermal or inhalation exposure is not possible based on animal welfare/ethical reasons.
It is expected that the DNEL for local effects after single and repeated exposure will be sufficient to protect for any systemic effects including effects on the development.
Justification for selection of Effect on developmental toxicity: via oral route:
Waiver based on relevance of the oral exposure route for extrapolation to the relevant routes of occupational exposure (dermal (and inhalation))
Justification for selection of Effect on developmental toxicity: via inhalation route:
waiver based on the local effects that are expected based on the corrosiveness of the test substance. For ethical reasons no repeated dose study should be performed.
Justification for selection of Effect on developmental toxicity: via dermal route:
waiver based on the local effects that are expected based on the corrosiveness of the test substance. For ethical reasons no repeated dose study should be performed.
Justification for classification or non-classification
No classification for reproduction or developmental effects is considered necessary.
Additional information
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.
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