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Toxicological information

Genetic toxicity: in vitro

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Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Remarks:
Type of genotoxicity: gene mutation
Type of information:
read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Justification for type of information:
See category justification attached in Section 13 for more information. Evaluating alkyl phenate sulfides (“phenates”) as a category is appropriate based on similar chemical structures and starting materials, manufacturing processes, physical and chemical properties, functional uses as a lubricating oil additive, and toxicological data. Regarding the ECHA Read-Across Assessment Framework (2017), the alkyl phenate category fit into Scenario 6 (different compounds with the same effect and no variation in the strength of that effect across substances).

Phenates in this category are manufactured in a similar way and from the same staring alkylphenol, tetrapropenyl phenol (“TPP”, EC 310-154-3; AKA phenol, dodecyl-, branched (PDB, PDDP)). The primary difference among the phenates is if they have calcium carbonate basing; the amount of overbasing may also differ. However, based on the trends observed with the robust toxicology data for the category, the amount of calcium carbonate overbasing is not expected to alter the hazards, especially as the core phenate functionality does not change and calcium carbonate has a low hazard potential.

Based on the data and consistent trends observed among category members, phenates have low hazard for human health and the environment. The registered (target) substance, EC 701-208-0 is very similar to EC 701-251-5 and this substance can be used as direct read across (and is used as the test material in the target record, where data exists for this source substance); EC 701-249-4 and 272-388-1 serve to bracket EC 701-208-0 with EC 701-251-5 regarding different levels of calcium carbonate overbasing.

Data source

Materials and methods

Test material

Constituent 1
Chemical structure
Reference substance name:
Phenol, paraalkylation products with C10-15 branched olefins ( C12 rich) derived from propene oligomerization, calcium salts, sulfurized, including distillates (petroleum), hydrotreated, solvent-refined, solvent-dewaxed, or catalyc dewaxed, light or heavy paraffinic C15-C50
EC Number:
701-249-4
Molecular formula:
A molecular formula for this substance does not exist because it is a UVCB. The molecular formula for a theoretical representative structure is C36H58Ca2O4Sx where x = 1-3.
IUPAC Name:
Phenol, paraalkylation products with C10-15 branched olefins ( C12 rich) derived from propene oligomerization, calcium salts, sulfurized, including distillates (petroleum), hydrotreated, solvent-refined, solvent-dewaxed, or catalyc dewaxed, light or heavy paraffinic C15-C50
Details on test material:

Phenol, dodecyl-, sulfurized, calcium salts
Testing was performed on a commercial sample of this material. Typical purity of this material as distributed in commerce is 60% alkyl phenol sulfide and 40% highly refined lubricant base oil.

Method

Metabolic activation:
with and without
Metabolic activation system:
S9 mix

Results and discussion

Test results
Key result
Species / strain:
other: S. typhimurium TA 98, TA 100, TA 1535, TA 1537 and E. coli WP2 uvrA
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid

Any other information on results incl. tables

All test validity criteria were satisfied. There was no evidence of cytotoxicity based on condition of the background lawn or revertants/plate data at doses up to 10,000 µg/plate. The greatest mean number of revertants/plate over concurrent controls among all test doses, all strains and for both assays was 100% (TA 1537, next highest 81%) with S-9 and 100% (TA 1535 and 1537, next highest 47%) without S-9. There was no indication of a dose-related decrease or increase of mean revertants/plate.

Applicant's summary and conclusion

Conclusions:
Not mutagenic with or without metabolic activation

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