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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Endpoint:
developmental toxicity
Data waiving:
other justification
Justification for data waiving:
other:

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed

Materials and methods

Limit test:
no

Test animals

Species:
other: Alpk:APfSD (wistar-derived)

Administration / exposure

Route of administration:
oral: unspecified
Frequency of treatment:
Dosing regime: 7 days/week
No. of animals per sex per dose:
Number of dams and doses
24 at CA 0 mg/kg or mg/l
24 at CA 100 mg/kg or mg/l
24 at CA 300 mg/kg or mg/l
24 at CA 1000 mg/kg or mg/l

Results and discussion

Results: maternal animals

Effect levels (maternal animals)

open allclose all
Dose descriptor:
NOAEL
Effect level:
21 mg/kg bw/day (nominal)
Based on:
test mat.
Basis for effect level:
other: maternal toxicity
Dose descriptor:
NOAEL
Effect level:
300 mg/kg bw/day (nominal)
Based on:
test mat.
Basis for effect level:
other: developmental toxicity

Results (fetuses)

Fetal abnormalities

Abnormalities:
not specified

Overall developmental toxicity

Developmental effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
Substance is not toxic for development