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REACH

Esterification products of 2,2-dimethylpropane-1,3-diol with n-heptanoic acid and n-octanoic acid and n-decanoic acid

EC number: 816-315-9 | CAS number: 70024-75-8

Life Cycle description
Uses advised against

Toxicological information

Endpoint summary

Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

Not mutagenic; based on read-across from supporting substance (structural analogue or surrogate).

Link to relevant study records

Reference

Endpoint:: in vitro gene mutation study in bacteria
Remarks:: Type of genotoxicity: gene mutation
Type of information:: migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:: weight of evidence
Study period:: 01 Mar - 11 Mar 1988
Reliability:: 2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:: other: GLP-Guideline study with acceptable restrictions (no analytical purty reported; no E.coli strain tested)
Qualifier:: equivalent or similar to guideline
Guideline:: OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Version / remarks:: adopted in 1983
Deviations:: yes
Remarks:: no analytical purty reported; no E.coli strain tested
GLP compliance:: yes
Type of assay:: bacterial reverse mutation assay
Target gene:: his operon
Species / strain / cell type:: S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Additional strain / cell type characteristics:: not specified
Species / strain / cell type:: S. typhimurium TA 1538
Additional strain / cell type characteristics:: not specified
Metabolic activation:: with and without
Metabolic activation system:: S9-mix
Test concentrations with justification for top dose:: First and second experiment: 8, 40, 200, 1000 and 5000 µg/plate
Vehicle / solvent:: - Vehicle(s)/solvent(s) used: Tween 80 / water
Untreated negative controls:: no
Negative solvent / vehicle controls:: yes
True negative controls:: no
Positive controls:: yes
Positive control substance:: other: With and Without S9: sodium azide (2 µg/plate) for TA100 and TA1535; 9-aminoacridine (80 µg/plate) for TA1537; 4-nitro-o-phenylendiamine (40 µg/plate) for TA98 and TA1538. With and without S9: 2 aminoanthracene (2-AA; 2.5 or 5 µg/plate) for all strains
Details on test system and experimental conditions:: METHOD OF APPLICATION: in agar (plate incorporation)

DURATION
- Exposure duration: 48 h

NUMBER OF REPLICATIONS: triplicates each in two independent experiments
Rationale for test conditions:: In accordanec with test guidelines
Evaluation criteria:: The test material was considered positive in this test system if the following criteria were met:
- The plate background from the non revertant bacteria showed no growth reduction in comparison to the correspondent negative control.
- The spontaneous mutation rate of the strains tested was within the characteristic range of the spontaneous mutation.
- The positive controls showed mutation rates that exceeded the control values of the TA100 at least by a factor 2.0 and the other tester strains, at least by a factor 3.0.
- For the test item, two-fold increases in mean revertant numbers were observed at more then one dose level in TA 100. For the other strains, an increase in the mutation rate greater than three-fold in comparison to the correspondent negative control was observed.
Statistics:: Mean values and standard deviation were calculated.
: Key result
Species / strain:: S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:: with and without
Genotoxicity:: negative
Cytotoxicity / choice of top concentrations:: no cytotoxicity
Vehicle controls validity:: valid
Untreated negative controls validity:: not examined
Positive controls validity:: valid
: Key result
Species / strain:: S. typhimurium TA 1538
Metabolic activation:: with and without
Genotoxicity:: negative
Cytotoxicity / choice of top concentrations:: no cytotoxicity
Vehicle controls validity:: valid
Untreated negative controls validity:: not examined
Positive controls validity:: valid
Remarks on result:: other: all strains/cell types tested
Remarks:: Migrated from field 'Test system'.
Conclusions:: Interpretation of results (migrated information):
negative

Endpoint conclusion

Endpoint conclusion:: no adverse effect observed (negative)

Genetic toxicity in vivo

Endpoint conclusion

Endpoint conclusion:: no study available

Additional information

Justification for classification or non-classification

According to the Regulation (EC) No 1272/2008 on classification, labelling and packaging of items and mixtures, the substance does not have to be classified and has no obligatory labelling requirement for genetic toxicity.

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