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Diss Factsheets

Administrative data

Description of key information

RA-A 16260-09-6 and 13276-08-9, skin sensitisation (OECD 406): not sensitising

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)
Remarks:
Summary of available data used for the endpoint assessment of the target substance
Adequacy of study:
key study
Justification for type of information:
refer to the analogue justification provided in IUCLID section 13
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across source
Key result
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
25%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other:
Remarks:
Source: CAS 16260-09-6, Notox C.V., 1986h
Key result
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
5%
No. with + reactions:
1
Total no. in group:
20
Clinical observations:
Moderate and diffuse reaction; two other animals demonstrated red spots (scattered reaction) which were not considered positive.
Remarks on result:
other:
Remarks:
Source: CAS 16260-09-6, Notox C.V., 1986h
Key result
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
1%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other:
Remarks:
Source: CAS 16260-09-6, Notox C.V., 1986h
Key result
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other:
Remarks:
Source: CAS 16260-09-6, Notox C.V., 1986h
Reading:
2nd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
25%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other:
Remarks:
Source: CAS 16260-09-6, Notox C.V., 1986h
Reading:
2nd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
5%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other:
Remarks:
Source: CAS 16260-09-6, Notox C.V., 1986h
Reading:
2nd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
1%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other:
Remarks:
Source: CAS 16260-09-6, Notox C.V., 1986h
Reading:
2nd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
0%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other:
Remarks:
Source: CAS 16260-09-6, Notox C.V., 1986h
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
Dose level:
25%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other:
Remarks:
Source: CAS 16260-09-6, Notox C.V., 1986h
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
Dose level:
5%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other:
Remarks:
Source: CAS 16260-09-6, Notox C.V., 1986h
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
Dose level:
1%
No. with + reactions:
0
Total no. in group:
9
Remarks on result:
other:
Remarks:
Source: CAS 16260-09-6, Notox C.V., 1986h
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
Dose level:
0%
No. with + reactions:
0
Total no. in group:
9
Remarks on result:
other:
Remarks:
Source: CAS 16260-09-6, Notox C.V., 1986h
Reading:
1st reading
Hours after challenge:
48
Group:
positive control
Remarks on result:
other: not determined
Remarks:
Source: CAS 16260-09-6 and 13276-08-9, Notox C.V., 1986g,h
Key result
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
25%
No. with + reactions:
0
Total no. in group:
18
Remarks on result:
other:
Remarks:
Source: CAS 13276-08-9, Notox C.V., 1986g
Key result
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
5%
No. with + reactions:
0
Total no. in group:
18
Remarks on result:
other:
Remarks:
Source: CAS 13276-08-9, Notox C.V., 1986g
Key result
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
1%
No. with + reactions:
0
Total no. in group:
18
Remarks on result:
other:
Remarks:
Source: CAS 13276-08-9, Notox C.V., 1986g
Key result
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0%
No. with + reactions:
0
Total no. in group:
18
Remarks on result:
other:
Remarks:
Source: CAS 13276-08-9, Notox C.V., 1986g
Reading:
2nd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
25%
No. with + reactions:
0
Total no. in group:
18
Remarks on result:
other:
Remarks:
Source: CAS 13276-08-9, Notox C.V., 1986g
Reading:
2nd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
5%
No. with + reactions:
0
Total no. in group:
18
Remarks on result:
other:
Remarks:
Source: CAS 13276-08-9, Notox C.V., 1986g
Reading:
2nd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
1%
No. with + reactions:
0
Total no. in group:
18
Remarks on result:
other:
Remarks:
Source: CAS 13276-08-9, Notox C.V., 1986g
Reading:
2nd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
0%
No. with + reactions:
0
Total no. in group:
18
Remarks on result:
other:
Remarks:
Source: CAS 13276-08-9, Notox C.V., 1986g
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
Dose level:
25%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other:
Remarks:
Source: CAS 13276-08-9, Notox C.V., 1986g
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
Dose level:
5%
No. with + reactions:
0
Total no. in group:
9
Clinical observations:
Skin reddening observed at this site should be attributed to mechanical injury (probably shaving). Site excluded from evaluation.
Remarks on result:
other:
Remarks:
Source: CAS 13276-08-9, Notox C.V., 1986g
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
Dose level:
1%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other:
Remarks:
Source: CAS 13276-08-9, Notox C.V., 1986g
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
Dose level:
0%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other:
Remarks:
Source: CAS 13276-08-9, Notox C.V., 1986g
Reading:
2nd reading
Hours after challenge:
72
Group:
negative control
Dose level:
25%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other:
Remarks:
Source: CAS 13276-08-9, Notox C.V., 1986g
Reading:
2nd reading
Hours after challenge:
72
Group:
negative control
Dose level:
5%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other:
Remarks:
Source: CAS 13276-08-9, Notox C.V., 1986g
Reading:
2nd reading
Hours after challenge:
72
Group:
negative control
Dose level:
1%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other:
Remarks:
Source: CAS 13276-08-9, Notox C.V., 1986g
Reading:
2nd reading
Hours after challenge:
72
Group:
negative control
Dose level:
0%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other:
Remarks:
Source: CAS 13276-08-9, Notox C.V., 1986g
Interpretation of results:
other: CLP/EU GHS criteria are not met, no classification required according to Regulations (EC) No 1272/2008.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

There is no data available on the skin sensitisation potential of (Z)-N-octadecyldocos-13-enamide (CAS 10094-45-8). In order to fulfil the standard information requirements set out in Annex VII, 8.3, in accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006, read-across from structurally related substances was conducted in accordance with the Read-Across Assessment Framework (RAAF) (ECHA, 2017).

A detailed justification for the grouping of chemicals and read-across is provided in the technical dossier (see IUCLID section 13.2).

 

Reliable studies on skin sensitisation are available for the structurally related substances (Z)-N-octadec-9-enylhexadecan-1-amide (CAS 16260-09-6) and N-octadecylstearamide (CAS 13276-08-9), which are used for read-across based on the analogue approach.

The skin sensitising potential of (Z)-N-octadec-9-enylhexadecan-1-amide (CAS 16260-09-6) was evaluated in a Split Adjuvant Test performed according to OECD 406 due to the low solubility of the test substance (Notox C.V., 1986h). In the induction phase of the study, test substance in corn oil was applied epicutaneously to the skin of 20 female Dunkin-Hartley guinea pigs under occlusive conditions on Days 0, 2, 4 and 7. The concentration of the test substance in vehicle was 25% (w/v) on Days 0 and 2 as well as 5% (w/v) on Days 4 and 7 of induction treatment. In addition, 2 intradermal injections of 0.1 mL Freund's Complete Adjuvant (FCA) were performed on Day 4 on either side of sensitisation area in both the treatment group and the control group (consisting of 10 further female animals). For challenge exposure on Day 21, the test substance at 25, 5, 1 and 0% (w/v) concentration in corn oil was applied for 24 h to the skin of the left flank of treated and control animals. Skin reactions were evaluated 24 and 48 h after removal of the dressing. Except for one animal showing moderate and diffuse reaction after challenge treatment with 5% of the test substance in corn oil, no positive reactions were observed after challenge application. Therefore, a sensitisation rate of 5% was obtained, which, however, did not fulfil the criteria for a positive result in this study. The reliability of the study was limited since no positive control was included in the assay. However, the animals of the negative control group, which actually were challenge controls, did not show skin reactions attributed to skin sensitisation. Under the conditions of this assay, it was concluded that the test substance was not sensitising to skin.

In a Split Adjuvant Test with N-octadecylstearamide (CAS 13276-08-9) according to OECD 406 performed under identical conditions as described above, no skin sensitisation reactions were observed in any of the treated Dunkin-Hartley guinea pigs after challenge exposure to the test substance in corn oil on Day 21 (Notox C.V., 1986g). However, similar to the aforementioned skin sensitisation study, the reliability of the test was limited since no positive control was included in the assay. However, the animals of the negative control group, which actually were challenge controls, did not show skin reactions attributed to skin sensitisation. Under the conditions of this assay, the test substance was not considered to be a skin sensitiser.

 

Based on the results of the available studies on the skin sensitisation potential of the structural analogues, it can be concluded that (Z)-N-octadecyldocos-13-enamide (CAS 10094-45-8) is not skin sensitising.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

The available data on the skin sensitisation potential of (Z)-N-octadec-9-enylhexadecan-1-amide (CAS 16260-09-6) and N-octadecylstearamide (CAS 13276-08-9), which are structurally related substances to (Z)-N-octadecyldocos-13-enamide (CAS 10094-45-8) according to the criteria of Regulation (EC) No 1907/2006, Annex XI, 1.5, do not meet the criteria for classification according to Regulation (EC) No 1272/2008; therefore, (Z)-N-octadecyldocos-13-enamide (CAS 10094-45-8) is not expected to exert a skin sensitisation potential, either, and the data are conclusive but not sufficient for classification.