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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Toxicity to reproduction

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Administrative data

Endpoint:
screening for reproductive / developmental toxicity
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Cross-reference
Reason / purpose for cross-reference:
read-across source
Reference
Endpoint:
reproductive toxicity, other
Remarks:
summary of different reproductive toxicity studies
Type of information:
other: collection of data
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 416 (Two-Generation Reproduction Toxicity Study)
Key result
Dose descriptor:
NOAEL
Effect level:
> 350 mg/kg bw/day
Based on:
test mat.
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:
> 350 mg/kg bw/day (nominal)
Based on:
test mat.
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

Data source

Materials and methods

Test material

Test material form:
solid

Results and discussion

Results: P0 (first parental generation)

Effect levels (P0)

Key result
Dose descriptor:
NOAEL
Effect level:
> 350 mg/kg bw/day
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: NOAEL = highest dose tested

Target system / organ toxicity (P0)

Key result
Critical effects observed:
no

Results: F1 generation

Effect levels (F1)

Key result
Dose descriptor:
NOAEL
Generation:
F1
Effect level:
> 350 mg/kg bw/day (nominal)
Based on:
test mat.
Remarks:
dams were dosed
Sex:
male/female
Basis for effect level:
other: NOAEL = highest dose tested

Overall reproductive toxicity

Key result
Reproductive effects observed:
no

Applicant's summary and conclusion