Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.

Diss Factsheets

Administrative data

Key value for chemical safety assessment

Effects on fertility

Link to relevant study records
Reference
Endpoint:
screening for reproductive / developmental toxicity
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reason / purpose for cross-reference:
read-across source
Key result
Dose descriptor:
NOAEL
Effect level:
> 2 680 mg/kg diet
Based on:
other: calculated for target substance to be registered
Sex:
male/female
Basis for effect level:
other: NOAEL = highest dose tested
Key result
Dose descriptor:
NOAEL
Effect level:
> 160 mg/kg bw/day (actual dose received)
Based on:
other: calculated for target substance to be registered
Sex:
male/female
Basis for effect level:
other: NOAEL = highest dose tested
Key result
Critical effects observed:
no
Key result
Dose descriptor:
NOAEL
Generation:
F1
Effect level:
> 2 680 mg/kg diet
Based on:
other: calculated for target substance to be registered
Remarks:
dams were dosed
Sex:
male/female
Basis for effect level:
other: NOAEL = highest dose tested
Key result
Dose descriptor:
NOAEL
Generation:
F1
Effect level:
> 160 mg/kg bw/day (actual dose received)
Based on:
other: calculated for target substance to be registered
Remarks:
dams were dosed
Sex:
male/female
Basis for effect level:
other: NOAEL = highest dose tested
Key result
Critical effects observed:
no
Key result
Reproductive effects observed:
no
Effect on fertility: via oral route
Endpoint conclusion:
no adverse effect observed
Study duration:
subacute
Species:
rat
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

Link to relevant study records
Reference
Endpoint:
developmental toxicity
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reason / purpose for cross-reference:
read-across source
Key result
Dose descriptor:
NOAEL
Effect level:
> 2 680 mg/kg diet
Based on:
test mat.
Remarks:
calculated for target substance to be registered
Basis for effect level:
other: NOAEL = highest dose tested
Key result
Dose descriptor:
NOAEL
Effect level:
> 160 mg/kg bw/day (actual dose received)
Based on:
test mat.
Remarks:
calculated for target substance to be registered
Basis for effect level:
other: NOAEL = highest dose tested
Key result
Abnormalities:
no effects observed
Key result
Dose descriptor:
NOAEL
Effect level:
> 2 680 mg/kg bw/day (nominal)
Based on:
test mat.
Remarks:
dams were dosed; calculated for target substance to be registered
Sex:
male/female
Basis for effect level:
other: NOAEL = highest dose tested
Key result
Dose descriptor:
NOAEL
Effect level:
> 160 mg/kg bw/day (nominal)
Based on:
test mat.
Remarks:
dams were dosed; calculated for target substance to be registered
Sex:
male/female
Basis for effect level:
other: NOAEL = highest dose tested
Key result
Abnormalities:
no effects observed
Key result
Developmental effects observed:
no
Effect on developmental toxicity: via oral route
Endpoint conclusion:
no adverse effect observed
Study duration:
subacute
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

In the reproduction/developmental toxicity screening study performed with the read-across source substance no adverse effects were observed on fertility of the parental animals and no effects on the offspring were observed up to and including the highest dose. Accordingly, the target substance to be registered has not to be classified for reproductive toxicity according to Regulation 1272/2008.

Additional information