Butanedioic acid, sulfo-, C-[2-[(1-oxododecyl)amino]ethyl] ester, monosodium salt

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

Justification for type of information:

see attached read-across justification

Reason / purpose for cross-reference:

read-across source

Positive control results:

Animals of the same strain treated with α-hexyl cinnamic aldehyde in sesame oil exhibited a sensitising reaction in all animals in form of a moderate and confluent erythema (grade 2).

Key result

Reading:

1st reading

Hours after challenge:

48

Group:

test chemical

Dose level:

10% suspension of the test item in aqua ad iniectabilia (2mL)

No. with + reactions:

0

Total no. in group:

10

Key result

Reading:

2nd reading

Hours after challenge:

72

Group:

test chemical

Dose level:

10% suspension of the test item in aqua ad iniectabilia (2mL)

No. with + reactions:

0

Total no. in group:

10

Reading:

1st reading

Hours after challenge:

48

Group:

negative control

Dose level:

aqua ad iniectabilia (2mL)

No. with + reactions:

0

Total no. in group:

5

Remarks on result:

other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: aqua ad iniectabilia (2mL). No with. + reactions: 0.0. Total no. in groups: 5.0.

Reading:

2nd reading

Hours after challenge:

72

Group:

negative control

Dose level:

aqua ad iniectabilia (2mL)

No. with + reactions:

0

Total no. in group:

5

Remarks on result:

other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: negative control. Dose level: aqua ad iniectabilia (2mL). No with. + reactions: 0.0. Total no. in groups: 5.0.

Reading:

1st reading

Hours after challenge:

48

Group:

positive control

Dose level:

0.01% α-hexyl cinnamic aldehyde

No. with + reactions:

20

Total no. in group:

20

Clinical observations:

moderate and confluent erythema left flank

Remarks on result:

other: Reading: 1st reading. . Hours after challenge: 48.0. Group: positive control. Dose level: 0.01% α-hexyl cinnamic aldehyde . No with. + reactions: 20.0. Total no. in groups: 20.0. Clinical observations: moderate and confluent erythema left flank.

Reading:

2nd reading

Hours after challenge:

72

Group:

positive control

Dose level:

0.01% α-hexyl cinnamic aldehyde

No. with + reactions:

20

Total no. in group:

20

Clinical observations:

moderate and confluent erythema left flank

Remarks on result:

other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: positive control. Dose level: 0.01% α-hexyl cinnamic aldehyde . No with. + reactions: 20.0. Total no. in groups: 20.0. Clinical observations: moderate and confluent erythema left flank.

Interpretation of results:

GHS criteria not met

Conclusions:

Under the present test conditions, read-across test item containing 39.80% active ingredient, was found to be not sensitising to guinea pigs in a test model according to MAGNUSSON and KLIGMAN.

Executive summary:

The purpose of this study was to determine the potential of the read-across test item, containing 39.80% active ingredient, in guinea pigs in a test model according to MAGNUSSON and KLIGMAN.

From a preliminary experiment, it was decided to use a 0.5% concentration in aqua ad iniectabilia for the 1st (intracutaneous) stage, a 25% suspension in aqua ad iniectabilia for the 2nd (topical) induction stage and a 10% suspension in aqua ad iniectabilia for the challenge.

A 0.5% suspension in aqua ad iniectabilia chosen for the 1st (intracutaneous) induction stage revealed a discrete or patchy erythema in all 10 animals 24 and 48 hours after administration. 2 mL of a 25% suspension of the test item in aqua ad iniectabilia/animal chosen for the 2nd (topical) induction stage revealed a moderate and confluent erythema 48 hours and a discrete or patchy erythema 72 hours after start of exposure in all 10 animals. The challenge with 2 mL of a 10% suspension of the test item in aqua ad iniectabilia /animal - the maximum non-irritating concentration - revealed no skin irritation in any animal and, thus, the read-across test item had no sensitising properties.

The vehicle control revealed no skin reactions.

Animals of the same strain treated with α-hexyl cinnamic aldehyde in sesame oil exhibited a sensitising reaction in all animals in form of a moderate and confluent erythema (grade 2).

Behaviour of the animals remained unchanged. Body weights were not affected

Under the present test conditions, read-across test item containing 39.8% active ingredient, was found to be not sensitising to guinea pigs in a test model according to MAGNUSSON and KLIGMAN.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

Guinea-pig maximisation testing

No data were available for the registered substance, however a study was available for read across substance 'Butanedioic acid, 2 (or 3) - sulfo-, 4 - [2- [(1-oxo (C12 - C18 (even numbered) and C18unsaturated) alkyl)) amino] ethyl] esters', disodium salts (test item containing 39.80% active ingredient) for its sensitising properties in the Magnusson and Kligman Maximisation Test in guinea pigs (Haferkorn, 2013d). A 0.5% suspension in aqua ad iniectabilia chosen for the 1st (intracutaneous) induction stage revealed a discrete or patchy erythema in all 10 animals 24 and 48 hours after administration. 2 mL of a 25% suspension of the test item in aqua ad iniectabilia/animal chosen for the 2nd (topical) induction stage revealed a moderate and confluent erythema 48 hours and a discrete or patchy erythema 72 hours after start of exposure in all 10 animals. The challenge with 2 mL of a 10% suspension of the test item in aqua ad iniectabilia /animal - the maximum non-irritating concentration - revealed no skin irritation in any animal and, thus, the test item had no sensitising properties. The vehicle control revealed no skin reactions. Animals of the same strain treated with α-hexyl cinnamic aldehyde in sesame oil exhibited a sensitising reaction in all animals in form of a moderate and confluent erythema (grade 2).

Behaviour of the animals remained unchanged. Body weights were not influenced.

Under the present test conditions, test item containing 39.80% active ingredient, was found to be not sensitising to guinea pigs in a test model according to MAGNUSSON and KLIGMAN.

 

Conclusion

- Based on the negative findings in the guinea-pig maximisation test with read-across substances, potential for skin sensitisation with registered substance can be excluded.

- Further information supporting the absence of sensitisation potential is also provided in the read across justification for the N2 subgroup, showing that other guinea-pig maximisation was also negative (justification with data matrix separately attached in Section 13).

A key study was available for read across substance 'Butanedioic acid, 2 (or 3) - sulfo-, 4 - [2- [(1-oxo (C12 - C18 (even numbered) and C18unsaturated) alkyl)) amino] ethyl] esters, disodium salts' according to the Magnusson and Kligman Maximisation Test in guinea pigs. Induction with 0.5% suspension (intracutaneous) and 2 mL of a 25% suspension , followed by challenge with 2 mL of a 10% suspension of the test item - the maximum non-irritating concentration - revealed no skin irritation in any animal and, thus, the test item had no sensitising properties. 

Justification for classification or non-classification

As there was no indication for sensitisation from the Guinea-pig Maximisation test, classification for skin sensitisation is not needed according to CLP (No. 1272/2008 of 16 December 2008).