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Toxicological information

Toxicity to reproduction

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Administrative data

Endpoint:
screening for reproductive / developmental toxicity
Type of information:
(Q)SAR
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
2020

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 421 (Reproduction / Developmental Toxicity Screening Test)
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
GLP compliance:
no
Limit test:
no

Test material

Reference
Name:
Unnamed
Test material form:
solid: particulate/powder

Results and discussion

Results: P0 (first parental generation)

Effect levels (P0)

Key result
Dose descriptor:
NOAEL
Effect level:
>= 50 mg/kg bw/day
Based on:
not specified
Sex:
not specified
Basis for effect level:
other: N/A
Remarks on result:
other: repeated oral toxicityrepeated oral toxicity

Results: P1 (second parental generation)

Effect levels (P1)

Key result
Dose descriptor:
NOAEL
Effect level:
>= 50 mg/kg bw/day
Based on:
test mat.
Sex:
not specified
Basis for effect level:
other: N/A
Remarks on result:
other: repeated oral toxicity

Results: F1 generation

Effect levels (F1)

Dose descriptor:
NOAEL
Generation:
F1
Effect level:
>= 50 mg/kg bw/day (nominal)
Based on:
not specified
Sex:
not specified
Basis for effect level:
other: n/a
Remarks on result:
other: repeated oral toxicity

Overall reproductive toxicity

Key result
Reproductive effects observed:
no
Lowest effective dose / conc.:
50 mg/kg bw/day
Treatment related:
no

Applicant's summary and conclusion

Conclusions:
The combination of read across, QSAR analysis and QSAR database retrieval reveals that the theoretical NOAEL of reproductive / developmental toxicity for 4 - (1-ox2-propenyl) – morpholine in rats is ≥ 50 mg / kg bw / day (repeated oral toxicity).