Reaction products of “Fatty Acids, C16-18 and C18-unsatd., Me esters; sulfuric acid and sodium hydroxide

Endpoint summary

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Reference

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Justification for type of information:

Both source and target substances are sodium salts of sulfonated methyl esters. The only difference is the chain length (C14 for source substance and C16-18 for the target substance). It is hypothized that the common functional groups (sulfon group and methyl-ester group) are driving the behaviour and effects of the substance and that the difference in chain length (C14 vs C16-18) has a negligible impact on the toxicity.
Available data for acute oral toxicity and mutagenicity for both substances show a slightly lower hazard potential for oral toxicity of the target substance compared to the source substance. Therefore, the source substance can be considered as worst-case for the target substance and the read-across approach can be considered as conservative. Both source and target substances are classified as H315 (causes skin irritation) and H319 (causes serious eye irritation).

Reason / purpose for cross-reference:

read-across source

Qualifier:

according to guideline

Guideline:

OECD Guideline 406 (Skin Sensitisation)

GLP compliance:

not specified

Species:

guinea pig

Strain:

Hartley

Sex:

male

Group:

test chemical

Remarks on result:

other: The substance showed no allergenic potency in the male guinea pig under the experimental conditions.

Interpretation of results:

GHS criteria not met

Conclusions:

The substance under investigation (C14-MES) showed no allergenic potency in the male guinea pig under the experimental conditions.
The same conclusion is drawn for Reaction products of “Fatty Acids, C16-18 and C18-unsatd., Me esters; sulfuric acid and sodium hydroxide".

Executive summary:

A skin sensitization test on the substance under investigation according to the OECD guideline (OECD, 1992; Magnusson and Kligman, 1969) was performed on albino Hartley guinea pigs.

The substance under investigation showed no allergenic potency in the male guinea pig under the experimental conditions.

The same conclusion is drawn for Reaction products of “Fatty Acids, C16-18 and C18-unsatd., Me esters; sulfuric acid and sodium hydroxide".

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

A skin sensitization test on tetradecanoic acid, 2-sulfo-, 1-methylester, sodium salt (C14-MES) according to the OECD 406 guideline (OECD, 1992) was performed on albino Hartley guinea pigs. The substance under investigation showed no allergenic potency in the male guinea pig under the experimental conditions.

Following a read-across approach, the same conclusion is drawn for Reaction products of “Fatty Acids, C16-18 and C18-unsatd., Me esters; sulfuric acid and sodium hydroxide" due to the structural similarity of the source and target substances.