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Developmental toxicity / teratogenicity

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developmental toxicity
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
Justification for type of information:
Based on the non-toxic profile of the substance, it is not considered scientifically justified on animal welfare grounds to propose an OECD guideline 408 test. The arguments for waiving such a test are: 1) Due to the results from the available tests, Sodium N-(2-carboxyethyl)-N-(2-ethylhexyl)-β-alaninate, CAS No 94441-92-6, does not have to be classified as dangerous in accordance with Directive 67/548/EEC and has no obligatory labelling requirement on any endpoint. As stated in Article 14 of the REACH legislation, the chemical safety assessment on a non-classified substance does not need to include an exposure assessment nor risk characterization. It is therefore not needed to perform any 90-day oral toxicity study in order to refine any DNEL derivations. 2) According to OECD guideline 408 at least 20 animals (10 females and 10 males) are to be used at each dose level, and at least three dose groups and a concurrent control shall be used in the 90-day oral toxicity study, resulting in the use of 80 animals in total. Based on animal welfare grounds, it is not considered ethically justified to perform a test using 80 animals to perform an additional test on a non-toxic substance. The possibility to perform a limit test is given in the guidance with one dose level of at least 1000 mg/kg bw for substances with low toxicity. The lack of any effects at 1000 mg/kg bw in the 28 day oral toxicity study makes it implausible to expect effects in a prolonged study, since a LOAEL could not be identified in the already performed repeated dose study. A 90-day oral toxicity study is therefore not expected to add any further relevant knowledge on this endpoint. 3) In Directive 67/548/EEC, the EU CLP (GHS) criteria for classification for Specific Target Organ Toxicity (STOT) are given based on data from a 90 day study. For classifying a substance according to STOT Category 2, the range for such effects is 10-<100 mg/kg/day. Performing a limited 90-day test on Sodium N-(2-carboxyethyl)-N-(2-ethylhexyl)-β-alaninate, CAS No 94441-92-6, with the proposed dose level of 1000 mg/kg bw would therefore not provide any additional data for classification and labeling purposes. Considering the above mentioned arguments, it is not regarded relevant from a scientific point, nor justified on animal welfare grounds, to perform a 90 Day Toxicity, oral (gavage) in rat according to OECD guideline 408

Data source

Materials and methods

Test animals

other: Not relevant

Results and discussion

Results (fetuses)

Fetal abnormalities

not specified

Overall developmental toxicity

Developmental effects observed:
not specified

Applicant's summary and conclusion

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