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Diss Factsheets

Administrative data

Description of key information

In an experimental study under GLP conditions according to OECD Test Guideline 406 with guinea pigs, the read-across source substance did not induce any skin sensitisation (reference 7.4.1-1).

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:
Please refer to section 13 for the read-across justification.
Reason / purpose for cross-reference:
read-across source
Reading:
2nd reading
Hours after challenge:
72
Group:
positive control
Dose level:
10 g/L
No. with + reactions:
3
Total no. in group:
10
Remarks on result:
positive indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
48
Group:
positive control
Dose level:
10 g/L
No. with + reactions:
5
Total no. in group:
10
Remarks on result:
positive indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
400 g/L
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
400 g/L
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
Dose level:
0 g/L
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
72
Group:
negative control
Dose level:
0 g/L
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
no indication of skin sensitisation
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

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


 


Guinea Pig Maximisation Test


The read-across test material was evaluated for skin sensitizing properties in the guinea pig maximization test (GPMT) according to OECD TG 406. Five female guinea pigs in the negative control group (group 1) treated with the vehicle (NaCl solution) and ten females in the test material group (group 2) were investigated (strain: Dunkin Hartley). Induction included intradermal injection of test material preparation in NaCl solution (25 g/L with and without Freund's complete adjuvant) on day 1, and topical application of test material preparation (25 g/L) for 48 hours starting on experimental day 8. Challenge by topical application of test material preparation in NaCl solution for 24 hours (400 g/L) was performed two weeks after topical induction. Readings were done at 48 and 72 hours.


 























Induction with



Challenge with



Positive/ animals


(after start of the challenge)



Positive/ animals overall



48h



72h



Test item



Test item



0/10



0/10



0/10



 


After challenge no positive reactions in the test material treated skin sites at both readings were seen. Under the given experimental conditions, the read-across substance showed no positive response. Thus, it can be regarded as non-sensitising to the skin.

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 does not require classification according to Regulation (EC) No 1272/2008 (CLP), as amended for seventeenth time in Regulation (EU) No 2021/849.