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Administrative data

Key value for chemical safety assessment

Effects on fertility

Description of key information

An assessment was undertaken based on available data on the individual constituents of the substance. It concluded that 2-ethylhexanoic acid, compound with 2-aminoethanol (1:1) should be classified as Repr. 2; H361d (Suspected of damaging the unborn child).

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:
2018
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: An assessment was undertaken based on available data on the individual constituents of the substance.
Qualifier:
no guideline required
Principles of method if other than guideline:
An assessment was undertaken based on available data on the individual constituents of the substance.
Dose descriptor:
NOAEL
Effect level:
300 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
reproductive performance
Remarks on result:
other: An assessment was undertaken based on available data on the individual constituents of the substance.
Dose descriptor:
NOAEL
Effect level:
25 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
clinical signs
mortality
body weight and weight gain
Remarks on result:
other: An assessment was undertaken based on available data on the individual constituents of the substance.
Critical effects observed:
no
Dose descriptor:
NOAEL
Generation:
F1
Effect level:
100 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: Foetal development
Remarks on result:
other: An assessment was undertaken based on available data on the individual constituents of the substance.
Critical effects observed:
no
Reproductive effects observed:
yes
Lowest effective dose / conc.:
250 mg/kg bw/day (nominal)
Treatment related:
yes
Relation to other toxic effects:
reproductive effects in the absence of other toxic effects
Dose response relationship:
not specified
Relevant for humans:
not specified
Conclusions:
2-ethylhexanoic acid, compound with 2-aminoethanol (1:1) should be classified as Repr. 2; H361d (Suspected of damaging the unborn child).
Executive summary:

An assessment was undertaken based on available data on the individual constituents of the substance. It concluded that 2-ethylhexanoic acid, compound with 2-aminoethanol (1:1) should be classified as Repr. 2; H361d (Suspected of damaging the unborn child).

Effect on fertility: via oral route
Endpoint conclusion:
adverse effect observed
Dose descriptor:
NOAEL
300 mg/kg bw/day
Study duration:
subacute
Species:
other: Not applicable. Assessment was based on studies performed on various animals.
Quality of whole database:
An assessment was undertaken based on available data on the individual constituents of the substance.
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available

Justification for classification or non-classification

2-ethylhexanoic acid, compound with 2-aminoethanol (1:1) should be classified as Repr. 2; H361d (Suspected of damaging the unborn child) based on the classification of its constituents 2-ethylhexanoic acid.

Additional information