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Diss Factsheets

Administrative data

Description of key information

Skin sensitisation in vivo (OECD 406): not sensitising

Study performed with the analogue source substance fatty acids C20-22 (even numbered), C18-22 (even numbered) alkyl esters (EC 701-233-7)

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:
negative control
Dose level:
50% in PEG 300
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
No signs of toxicity observed
Remarks on result:
no indication of skin sensitisation
Remarks:
Source: EC 701-233-7, NOF, 2008, GPMT
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
50% in PEG 300
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
No signs of toxicity observed
Remarks on result:
no indication of skin sensitisation
Remarks:
Source: EC 701-233-7, NOF, 2008, GPMT
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
50% in PEG 300
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No signs of toxicity observed
Remarks on result:
no indication of skin sensitisation
Remarks:
Source: EC 701-233-7, NOF, 2008, GPMT
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
50% in PEG 300
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No signs of toxicity observed
Remarks on result:
no indication of skin sensitisation
Remarks:
Source: EC 701-233-7, NOF, 2008, GPMT
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
3% in PEG 300
No. with + reactions:
2
Total no. in group:
10
Clinical observations:
No signs of toxicity observed
Remarks on result:
positive indication of skin sensitisation
Remarks:
RCC Study B59455; Source: EC 701-233-7, NOF, 2008, GPMT
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
3% in PEG 300
No. with + reactions:
6
Total no. in group:
10
Clinical observations:
No signs of toxicity observed
Remarks on result:
positive indication of skin sensitisation
Remarks:
RCC Study B59455; Source: EC 701-233-7, NOF, 2008, GPMT
Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008
Conclusions:
A reliable study conducted in accordance with OECD guideline 406 and GLP found the test material to be non-sensitising to the skin of guinea pigs in a maximisation test based on Magnusson and Kligman. No signs of toxicity were evident in the guinea pigs of the control or test group and no deaths occurred.
Executive summary:

The potential of the target substance docosyl docosanoate (CAS 17671-27-1) to induce skin sensitisation is estimated based on an adequate and reliable in vivo study with an analogue source substance. In this study the test substance did not induce skin sensitisation in guinea pigs as determined in a maximisation test according to Magnusson and Kligman. No signs of toxicity were evident in the guinea pigs of the control or test group and no deaths occurred. Therefore, the lack of a skin sensitisation potential is taken forward to the hazard assessment and the determination of the classification of the target substance. As explained in the Analogue Justification, the differences in molecular structure between the target and the source substances are unlikely to lead to differences in the skin sensitisation potential.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

No data on skin sensitisation are available for docosyl docosanoate (CAS 17671-27-1). An adequate and reliable study performed with an analogue source substance is, therefore, used to assess the endpoint skin sensitisation.

A Guinea Pig Maximisation Test was performed with fatty acids C20-22 (even numbered), C18-22 (even numbered) alkyl esters (EC 701-233-7) in 15 female albino Dunkin Hartley guinea pigs under GLP conditions (NOF, 2008, GPMT). The study was conducted in accordance with OECD guideline 406 and under GLP conditions. The intradermal induction of sensitisation was performed in the nuchal (flank) region with a 1% dilution of the test substance in polyethylene glycol (PEG 300) and in an emulsion of Freund's Complete Adjuvant (FCA)/physiological saline on Day 1. The epidermal induction was conducted for 48 h under occlusion with a 50% solution of the test substance in PEG 300 one week after the intradermal induction (Day 8) and following pre-treatment of the test areas with 10% sodium lauryl sulfate (SLS) approximately 24 h prior to application of the test substance. The animals of the control group were intradermally induced with PEG 300 and FCA/physiological saline and epidermally with PEG 300 under occlusion following pre-treatment with 10% SLS. Two weeks after epidermal induction the control and test animals were challenged by epidermal application of the test item at 50% in PEG 300 and PEG 300 alone, under an occlusive dressing. Cutaneous reactions were evaluated 24 and 48 h after removal of the dressing. Reliability checks were performed regularly to confirm the sensitivity and reliability of the test. The positive control group was exposed to alpha-hexylcinnamaldehyde, which led to signs of skin sensitisation in 6/10 animals. No skin reactions indicative of skin sensitisation were observed in the animals treated with fatty acids C20-22 (even numbered), C18-22 (even numbered) alkyl esters. Therefore, the test substance is not considered to exhibit a skin sensitising potential.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

The available data on skin sensitisation for an adequate analogue source substance do not meet the criteria for classification according to Regulation (EC) No. 1272/2008 (CLP). Data are conclusive but not sufficient for classification. Based on an analogue read-across approach, the target substance docosyl docosanoate (CAS 17671-27-1) is, therefore, also not classified for skin sensitisation.