Registration Dossier
Registration Dossier
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EC number: 617-560-2 | CAS number: 84377-83-3
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Description of key information
The solvate substance contains N,N-dimethylformamide ( Index number 616-001-00-X) which has a harmonised classification of H360D May injury the unborn child. The REACH Registration dossier expands that classification to H360FD May damage fertility or the unborn child. N,N-Dimethylformamide is present in the solvate at ~18% w/w, consequently it is a relevant substance for classification for reproductive toxicity. Based on the results obtained in a drinking water study conducted in CD-1 (Swiss) mice by the National Toxicology Program (USA), the NOAEL for fertility effects in both F0 and F1 generations is ~80 mg/kg bw/day. When applying this NOAEL based upon the concentration of N,N-formamide in the solvate substance, the overall NOAEL for fertility effects is 100/18* 80= 444 mg/kg bw/day
Link to relevant study records
- Endpoint:
- screening for reproductive / developmental toxicity
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- no further testing on fertility is necessary because the substance is known to have an adverse effect on fertility, meeting the criteria for classification as toxic for reproduction category 1A or 1B: May damage fertility (H360F), and the available data are adequate to support a robust risk assessment and classification and labelling
- Endpoint:
- screening for reproductive / developmental toxicity
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- other information
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: classification based upon component of solvate complex
- Reason / purpose for cross-reference:
- read-across source
Referenceopen allclose all
Effect on fertility: via oral route
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- NOAEL
- 444 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- mouse
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Effects on developmental toxicity
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- NOAEL
- 60 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
Effect on developmental toxicity: via inhalation route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via dermal route
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
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.
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.
