Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Description of key information

 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.

Link to relevant study records
Reference
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.
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.
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.
Critical effects observed:
not specified
Remarks on result:
not measured/tested
Critical effects observed:
no
Remarks on result:
not measured/tested
Critical effects observed:
no
Remarks on result:
not measured/tested
Critical effects observed:
no
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
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.

Effect on fertility: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
1 290 mg/kg bw/day
Study duration:
subacute
Species:
rat
Quality of whole database:
An assessment was performed based on literature data on the substance and literature data on an analogous substance.
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available

Effects on developmental toxicity

Effect on developmental toxicity: via oral route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via inhalation route
Endpoint conclusion:
no study available

Justification for classification or non-classification

The toxicity to reproduction of the registered substance was investigated using information on the effects on reproductive organs induced by the registered substance and data on an analogous substance. No significant adverse effects were identified.

It is concluded that the registered substance does not meet the criteria for classification according to Regulation (EC) No.1272/2008 on the Classification, Labelling and Packaging of Substances and Mixtures.