Registration Dossier

Administrative data

Description of key information

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).

 Migrated from Short description of key information: 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 selection of skin sensitisation endpoint: Key study

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).