Reaction products of amines, dicoco alkyl and glycollic acid

Endpoint summary

Additional information

Gene Mutation Assays

A Bacterial Reverse mutation Assays (Ames test) was performed according to the OECD 471 test guideline with the substance. The study (2005) was selected as a key study. No significant increases in the frequency of revertant colonies were recorded for any of the bacterial strains in both experiments, with any dose of the test material, either with or without metabolic activation. The study results indicate that the substance does not induce gene mutations in bacteria, whereas all positive control chemicals (with and without metabolic activation) induced a significant increase in the number of of colonies.The substance is therefore considered as non-mutagenic according in the Ames test.

A mammalian cell gene mutation assay in L5178Y cells was performed according to the OECD 476 test guideline with the substance. The study (2012) was selected as a keyy study. No significant increases in the frequency of mutant colonies was recorded, either in the absence or presence of metabolic activation.

The substance does not induce gene mutations in L5178Y cells under activation and non-activation conditions, whereas both positive control chemicals (with and without metabolic activation) induced significant increases in the frequency of mutations.The substance is therefore considered as negative for inducing gene mutations in L5178Y cells under the activation and non-activation conditions used in this assay.

 

Chromosomal aberration

The clastogenic potential of the substance was determined using an in vitro chromosome aberration test in Chinese Hamster Lung cells, which measures the potential of a substance to increase the incidence the of structural chromosome aberrations in cultured cells.

None of the test substance dose levels, up to the cytotoxicity limit, either with or without metabolic activation, induced significant increases in the frequency of cells with aberrations in either of two experiments. The substance does not induce structural aberrations in the chromosomes of CHL cells under activation and non-activation conditions, whereas both positive control chemicals (with and without metabolic activation) induced significant increases in the frequency of aberrant cells.The substance is therefore considered as negative for inducing chromosomal mutations in CHL cells under the activation and non-activation conditions used in this assay.

Micronucleus Test

The study was performed to assess the potential of the test item to produce damage to chromosomes or aneuploidy when administered to mice.

The micronucleus test was conducted using the intraperitoneal (i.p.) route in groups of seven mice (males) at the maximum tolerated dose (MTD) of 1200 mg/kg with 600 and 300 mg/kg as the two lower dose levels. Animals were killed 24 or 48 hours later, the bone marrow extracted, and smear preparations made and stained. Polychromatic (PCE) and normochromatic (NCE) erythrocytes were scored for the presence of micronuclei. Additional groups of mice were given a single ip dose of Arachis oil (7 male mice) or dosed orally with cyclophosphamide (5 male mice), to serve as vehicle and positive controls respectively. Vehicle and positive control animals were killed after 24 hours. There were no premature deaths at any dose level. The clinical signs of hunched posture and ptosis were observed at 1200 mg/kg in both the 48 and 24 hour dose groups. No statistically significant decreases in the PCE/NCE ratio were observed in any dose groups. The observation of clinical signs was taken to indicate that systemic absorption had occurred and exposure to the target tissue had been achieved. There was no evidence of any statistically significant increases in the incidence of micronucleated polychromatic erythrocytes in animals dosed with the test item when compared to the vehicle control group. The positive control group showed a marked increase in the incidence of micronucleated polychromatic erythrocytes hence confirming the sensitivity of the system to the known mutagenic activity of cyclophosphamide under the conditionsof the test. The test item was considered to be non-mutagenic under the conditions of the test.

Short description of key information:
- Ames Test 2005 (OECD 471, GLP, K, rel. 1): non mutagenic up to 5000 µg/plate in S. typhimurium TA 1535, TA 1537, TA 98, TA 100 & WP2uvrA-
- Human lymphocyte chromosome aberration test 2006 (OECD 473, GLP, K, rel. 1): non clastogenic up to cytotoxic limit
- Gene mutation assay in mouse lymphoma L5178Y cells (OECD 476, GLP, K rel1): non mutagenic up to maximum achievable exposure level
- Micronucleus study in the mouse (OECD 474, GLP, K rel1): non mutagenic up to the maximum tolerated dose level.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Harmonized classification:

The substance has no harmonized classification for human health according to the Regulation (EC) No. 1272/2008 including the ATP2.

Self classification:

Based on the available data, no additional classification is proposed according to the Annex VI of the Regulation (EC) No. 1272/2008 (CLP) and of the Directive 67/548/EEC.