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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Developmental toxicity / teratogenicity

Currently viewing:

Administrative data

Endpoint:
developmental toxicity
Type of information:
read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Justification for type of information:
Please refer to the category justification provided in the category object.

Data source

Materials and methods

Test material

Constituent 1
Chemical structure
Reference substance name:
Alcohols, C12-13, branched and linear, ethoxylated
EC Number:
500-457-0
EC Name:
Alcohols, C12-13, branched and linear, ethoxylated
Cas Number:
160901-19-9
Molecular formula:
not applicable; UVCB
IUPAC Name:
Alcohols, C12-13, branched and linear, ethoxylated

Test animals

Species:
rat

Results and discussion

Results: maternal animals

Effect levels (maternal animals)

Key result
Dose descriptor:
NOAEL
Effect level:
300 mg/kg bw/day (actual dose received)
Based on:
test mat.
Basis for effect level:
clinical signs

Maternal abnormalities

Key result
Abnormalities:
effects observed, treatment-related
Localisation:
other: clinical signs of systemic toxicity

Results (fetuses)

Effect levels (fetuses)

Key result
Dose descriptor:
NOAEL
Effect level:
300 mg/kg bw/day (actual dose received)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: reduced pup weights as a secondary effect to systemic maternal toxicity

Fetal abnormalities

Key result
Abnormalities:
effects observed, treatment-related
Localisation:
other: reduced pup weights as a secondary effect to systemic maternal toxicity

Overall developmental toxicity

Key result
Developmental effects observed:
yes
Lowest effective dose / conc.:
300 mg/kg bw/day (actual dose received)
Treatment related:
yes
Relation to maternal toxicity:
developmental effects as a secondary non-specific consequence of maternal toxicity effects
Dose response relationship:
yes
Relevant for humans:
no

Any other information on results incl. tables

For a detailed assessment of the developmental toxicity of the Alcohol Ethoxylates (AE) category, please refer to the category justification attached to the category object.

Applicant's summary and conclusion

Conclusions:
Applying read-across based on grouping of substances (category approach), reduced pup weights and a NOAEL for developmental toxicity of 300 mg/kg bw/day are predicted for the registered substance. Reduced pup weights are considered to be a secondary effect to systemic maternal toxicity.
Executive summary:

The available data on developmental toxicity in the 'branched & linear' subgroup of the Alcohol Ethoxylates (AE) category indicate reduced pup weights for the registered substance. Reduced pup weights are considered to be a secondary effect to systemic maternal toxicity. As explained in the category justification, the differences in molecular structure and composition between the registered substance and the members of the 'branched & linear' subgroup of the AE category are unlikely to lead to differences with respect to developmental toxicity.

Pursuant to compliance check final decision for several branched & linear AE substances, prenatal developmental toxicity studies in a first (rat) and/or a second (rabbit) species according to OECD guideline 414 are currently ongoing. The NOAEL for developmental toxicity established for alcohols, C12-13, branched and linear, ethoxylated, < 2.5 EO (CAS No. 160901-19-9, EC No. 500-457-0) will be re-evaluated once the results of the OECD 414 studies conducted with other branched & linear AE substances are available.