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Administrative data

Description of key information

A key study was available for read-across substance CAS 68784 -08 -7 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.

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:
REPORTING FORMAT FOR THE ANALOGUE APPROACH

1. HYPOTHESIS FOR THE ANALOGUE APPROACH
For details please refer to Read Across Justification Document, Section 13.2

2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
For details please refer to Read Across Justification Document, Section 13.2

3. ANALOGUE APPROACH JUSTIFICATION
For details please refer to Read Across Justification Document, Section 13.2

4. DATA MATRIX
For details please refer to Read Across Justification Document, Section 13.2
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 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

Read-across substance CAS 68784 -08 -7 (test item containing 39.80% active ingredient) was tested for its sensitising properties in the Magnusson and Kligman Maximisation Test in guinea pigs (Haferkorn, 2013c). 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.

In conclusion, 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, potential for skin sensitisation 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).

 

 

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 the EC CLP Guidance (No. 1272/2008 of 16 December 2008).