Registration Dossier

Administrative data

Endpoint:
screening for reproductive / developmental toxicity
Type of information:
other: expert judgement
Adequacy of study:
key study
Study period:
2017
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: data derived from expert judgement.

Data source

Reference
Reference Type:
other: expert judgement.
Title:
Unnamed
Year:
2017

Materials and methods

Principles of method if other than guideline:
Expert judgement
GLP compliance:
no

Test material

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

Results and discussion

Results: P0 (first parental animals)

Effect levels (P0)

Dose descriptor:
NOAEL
Effect level:
ca. 1 mg/kg bw/day (nominal)
Remarks on result:
other: RA based on expert judgement.

Target system / organ toxicity (P0)

Critical effects observed:
no

Results: F1 generation

Effect levels (F1)

Dose descriptor:
NOAEL
Generation:
F1
Effect level:
ca. 1 mg/kg bw/day (nominal)
Remarks on result:
other: RA based on expert judgement.

Target system / organ toxicity (F1)

Key result
Critical effects observed:
no

Overall reproductive toxicity

Reproductive effects observed:
no

Applicant's summary and conclusion

Conclusions:
Estimated NOAEL (reproductive toxicity)= 1 mg/kg bw/day based on the results of preliminary OECD TG 422.
Executive summary:

Estimated NOAEL (reproductive toxicity)= 1 mg/kg bw/day based on the results of preliminary OECD TG 422.