Registration Dossier

Administrative data

Endpoint:
screening for reproductive / developmental toxicity
Type of information:
other: Expert assessment
Adequacy of study:
key study
Study period:
October 04, 2017
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: An assessment was undertaken based on literature data on the substance and on structural analogues.

Data source

Reference
Reference Type:
other: Expert assessment
Title:
Unnamed
Year:
2017
Report Date:
2017

Materials and methods

Test guideline
Qualifier:
no guideline required
Principles of method if other than guideline:
An assessment was undertaken based on literature data on the substance and on structural analogues.

Test material

Reference
Name:
Unnamed
Type:
Constituent

Results and discussion

Results: P0 (first parental animals)

Effect levels (P0)

open allclose all
Key result
Dose descriptor:
LOAEL
Effect level:
3 870 other: mg/kg/day
Based on:
test mat.
Sex:
female
Basis for effect level:
body weight and weight gain
food consumption and compound intake
reproductive performance
Remarks on result:
other: An assessment was undertaken based on literature data on the substance and on structural analogues.
Key result
Dose descriptor:
NOAEL
Effect level:
1 290 other: mg/kg/day
Based on:
test mat.
Sex:
female
Basis for effect level:
body weight and weight gain
food consumption and compound intake
reproductive performance
Remarks on result:
other: An assessment was undertaken based on literature data on the substance and on structural analogues.

Target system / organ toxicity (P0)

Critical effects observed:
not specified

Results: P1 (second parental generation)

Effect levels (P1)

Remarks on result:
not measured/tested

Target system / organ toxicity (P1)

Critical effects observed:
no

Results: F1 generation

Effect levels (F1)

Remarks on result:
not measured/tested

Target system / organ toxicity (F1)

Critical effects observed:
no

Results: F2 generation

Effect levels (F2)

Remarks on result:
not measured/tested

Target system / organ toxicity (F2)

Critical effects observed:
no

Overall reproductive toxicity

Key result
Reproductive effects observed:
yes
Lowest effective dose / conc.:
3 870 other: mg/kg/day
Treatment related:
yes
Relation to other toxic effects:
not specified
Dose response relationship:
not specified
Relevant for humans:
not specified

Applicant's summary and conclusion

Conclusions:
An assessment was undertaken based on literature data on the substance and on structural analogues. It was concluded that the substance was not toxic to reproduction.
Executive summary:

 An assessment was undertaken based on literature data on the substance and on structural analogues. It was possible to establish a read-across between the registered substance and an analogue those toxicity to reproduction is expected to represent a worst-case scenario.

From the available data on this analogue it was concluded that that the LOAEL for maternal and developmental toxicity is 3,870 mg/kg/day while the NOAEL is 1,290 mg/kg/day. No additional animal testing is considered necessary for the purpose of assessing the reproductive/developmental toxicity of 1-[(2-hydroxyethyl)thio]propan-2-ol.