Registration Dossier
Registration Dossier
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EC number: 278-031-6 | CAS number: 74931-55-8
Toxicity to reproduction
Administrative data
- Endpoint:
- screening for reproductive / developmental toxicity
- Type of information:
- other: Expert assessment
- Adequacy of study:
- key study
- Study period:
- 2022
- 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.
Data source
Reference
- Reference Type:
- other: expert assessment
- Title:
- Unnamed
- Year:
- 2 022
- Report date:
- 2022
Materials and methods
Test guideline
- 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.
Test material
- Reference substance name:
- 2-ethylhexanoic acid, compound with 2-aminoethanol (1:1)
- EC Number:
- 278-031-6
- EC Name:
- 2-ethylhexanoic acid, compound with 2-aminoethanol (1:1)
- Cas Number:
- 74931-55-8
- Molecular formula:
- C10H23NO3
- IUPAC Name:
- 2-ethylhexanoic acid, compound with 2-aminoethanol (1:1)
- Test material form:
- liquid
- Details on test material:
- - Density: 0.999 g/cm3
Constituent 1
Results and discussion
Results: P0 (first parental generation)
Effect levels (P0)
open allclose all
- 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.
Target system / organ toxicity (P0)
- Critical effects observed:
- no
Results: F1 generation
Effect levels (F1)
- 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.
Target system / organ toxicity (F1)
- Critical effects observed:
- no
Overall reproductive toxicity
- 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
Applicant's summary and conclusion
- Conclusions:
- 2-ethylhexanoic acid, compound with 2-aminoethanol (1:1) should be classified as Repr. 1B; H360d (May damage the unborn child) based on the classification of its constituent 2-ethylhexanoic acid adopted on 16.02.2022.
- Executive summary:
The toxicity to reproduction of 2-ethylhexanoic acid, compound with 2-aminoethanol (1:1) via the oral route is expected to be driven by the toxicity to reproduction of its constituents, namely 2-ethylhexanoic acid and 2-aminoethanol.
An assessment was undertaken based on available data on the individual constituents of the substance and 2-ethylhexanoic acid was identified as the most hazardous constituent in regards to the toxicity to reproduction.
A classification as Repr. 1B; H360d (May damage the unborn child) for 2- ethylhexanoic acid and its salts was adopted on 16.02.2022 as reported in the 18th "Adaptation to Technical Progress (ATP)" document C(2022) 846.
It is concluded that 2-ethylhexanoic acid, compound with 2-aminoethanol (1:1) should be classified as Repr. 1B; H360d
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