Registration Dossier

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

Referenceopen allclose all

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:
read-across source
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