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Description of key information

Based on the results of the study conducted with the read-across source substance, the test item is considered to be a potentially strong skin sensitizer.

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:
refer to analogue justification provided in IUCLID section 13
Reason / purpose for cross-reference:
read-across source
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
Induction: 1% in sesame oil, 1% in 50% Freund`s Adjuvants and 50% Freund`s Adjuvant, repectively (intradermal), 25% in sesame oil (epicutaneous); challenge: 25% in sesame oil
No. with + reactions:
6
Total no. in group:
10
Clinical observations:
No signs of systemic toxicity were observed. Discrete or patchy erythema (5/10) and moderate to confluent erythema (1/10) were noted.
Remarks on result:
positive indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
Induction: 1% in sesame oil, 1% in 50% Freund`s Adjuvants and 50% Freund`s Adjuvant, repectively (intradermal), 25% in sesame oil (epicutaneous); challenge: 25% in sesame oil
No. with + reactions:
10
Total no. in group:
10
Clinical observations:
No signs of systemic toxicity occured. Discrete to patchy erythema (1/10), moderate to confluent erythema (6/10) and intense erythema and swelling (3/10) were observed. Dry, rough and scaly skin (10/10) and skin induration (9/10) were noted.
Remarks on result:
positive indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
Induction: sesame oil, 50% Freund`s Adjuvants and sesame oil in 50% Freund`s Adjuvant, repectively (intradermal), sesame oil (epicutaneous); challenge: 25% in sesame oil
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
No skin reactions and signs of systemic toxicity were observed
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
Induction: sesame oil, 50% Freund`s Adjuvants and sesame oil in 50% Freund`s Adjuvant, repectively (intradermal), sesame oil (epicutaneous); challenge: 25% in sesame oil
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
No skin reactions and signs of systemic toxicity were observed
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
Challenge: 25% α-hexylcinnamaldehyde in polyethylene glycole 400
No. with + reactions:
8
Total no. in group:
10
Clinical observations:
Discrete to patchy erythema (1/10), moderate to confluent erythema (2/10) and intense erythema and swelling (5/10) were observed.
Remarks on result:
positive indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
Challenge: 25% α-hexylcinnamaldehyde in polyethylene glycole 400
No. with + reactions:
9
Total no. in group:
10
Clinical observations:
Discrete to patchy erythema (1/10), moderate to confluent erythema (2/10) and intense erythema and swelling (6/10) were observed.
Remarks on result:
positive indication of skin sensitisation
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

No study data with the test item is available for skin sensitisation. Therefore, a read-across to the read-across substance with a very similar chemical structure and comparable physico-chemical parameters is used to evaluate the potential for skin senitisation potential of the test item.


A study according to OECD TG 406 was conducted to evaluate the skin sensitisation potential of the test material. Female guinea pigs received intradermal induction with 1 % test item in sesame oil, while dermal induction and challenge treatment was carried out with 25 % test item in sesame oil. No systemic toxicity was observed and the mean value for body weight and the body weight gain were comparable between the treatment group and control group. Intradermal injections with Freund's Adjuvant (with and without test substance) caused severe erythema and edema as well as indurations and encrustations. The administration sites treated with the test substance in sesame oil showed slight erythema and edema. Intradermal injections of the sesame oil alone exhibited no signs of irritation. Due to these strong irritation reactions of the skin, 10 % sodium dodecylsulfate was not administered at day 7. Severe erythema and edema, indurated, scabbed and encrusted skin as well as necrosis were observed after dermal induction treatment at the sites previously treated with Freund's Adjuvant after the removal of the patches on day 10. The administration sites treated with the test substance or the sesame oil alone showed no signs of irritation. After the dermal challenge no skin reactions were observed in the control group 24 and 48 hours after removal of the occlusive bandage. Six animals in the main test group showed very slight up to slight erythema 24 hours after removal of the occlusive bandage. 48 hours after removal of the occlusive bandage all animals showed positive skin reactions ranging from slight erythema to intense erythema and swelling. Additionally, induration, dry, rough and scally skin were observed. Under the conditions of the present study, all of ten animals of the treatment group showed a positive skin response after the challenge procedure. Based on the results of this study the test item may cause sensitization by skin contact.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008
The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. Based on available data on skin sensitisation, the test item requires classification for skin sensitisation potential Category 1 (H317: May cause an allergic skin reaction) according to Regulation (EC) No 1272/2008 (CLP).