Registration Dossier

Administrative data

Description of key information

The read-across substance showed no skin sensitisation potential in a GPMT (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
Key result
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
10 g/L
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
no signs of toxicity
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
Dose level:
10 g/L
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no signs of toxicity
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
10 g/L
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
no signs of toxicity
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
72
Group:
negative control
Dose level:
10 g/L
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no signs of toxicity
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
48
Group:
positive control
Dose level:
10 g/L
No. with + reactions:
7
Total no. in group:
10
Key result
Reading:
2nd reading
Hours after challenge:
72
Group:
positive control
Dose level:
10 g/L
No. with + reactions:
4
Total no. in group:
10
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 substance with a very similar chemical structure and comparable physico-chemical parameters is used to evaluate the skin sensitisation potential of the test item.

An in vivo study in guinea pigs according to OECD 406 was conducted to evaluate the skin sensitsation potential of the read-across substance. 10 females were treated with the vehicles liquid paraffin (group 1) and 20 females were treated with the read-across substance (group 2). The induction included intradermal injection of read-across substance preparation in liquid paraffin (5 g/L with and without Freund's complete adjuvant) on experimental day 1, and topical application of read-across substance preparation in liquid paraffin (50 g/L) for 48 hours on experimental day 8. The challenge was performed by topical application of the read-across substance preparation (10 g/L) for 24 hours, two weeks after topical induction and readings were taken at 48 hours and 72 hours after start of treatment. After challenge no positive reactions were seen 48 or 72 hours after treatment with the read-across substance. Based on the study results the read-across substance showed no skin sensitization potential.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Classification, Labeling, and Packaging Regulation (EC) No 1272/2008

The available data for skin sensitization is reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. Based on this data, the substance is considered to be not classified for skin sensitisation (UN GHS: No category) under Regulation (EC) No 1272/2008, as amended for the twelfth time in Regulation (EC) 2019/521.