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Diss Factsheets

Administrative data

Description of key information

The sensitization potential of decyl octadec-9-enoate and octadec-9-en-1-yl docos-13-enoate, structural analogues of the registration substance, were tested for their sensitisation potential according to OECD 429 and 406, respectively.

Based on the reported observations with these analogues, the registration substance is regarded as not sensitising.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Study period:
01 Feb - 03 Apr 1995
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Justification for type of information:
REPORTING FORMAT FOR THE ANALOGUE APPROACH
Please refer to cread across justification justification setcion 13.2

1. HYPOTHESIS FOR THE ANALOGUE APPROACH
Please refer to cread across justification justification setcion 13.2

2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
Please refer to cread across justification justification setcion 13.2

3. ANALOGUE APPROACH JUSTIFICATION
Please refer to cread across justification justification setcion 13.2

4. DATA MATRIX
Please refer to cread across justification justification setcion 13.2
Reason / purpose for cross-reference:
read-across source
Positive control results:
A reliability check is carried out at regular intervals with alpha-hexyl cinnamic aldehyde to check the sensitivity of the test system and the reliability of the experimental methods used by the test laboratory. An independent study was performed in October-December 1994 (report No. R 9400844), according to the Buehler method. During the first challenge with 25% alpha-hexyl cinnamic aldehyde, a sensitisation reaction was induced in 25% (5/20) of the Dunkin Hartley guinea pigs, while the second challenge did not lead to conclusive sensitisation reactions. In the negative control group, the first challenge induced sensitisation in 20% (2/10) of the animals, and the second challenge did not caused any sensitisation reactions. The 50% solution in peanut oil that was used for the topical inductions, caused weak to moderate skin irritation. A 25% solution was applied in the first challenge, while a 25% solution was applied to the left flank and 15, 20 and 25% solutions were applied to the right flank during the second challenge. As 20% of the animals in the negative control group reacted, the results of the reliability check are inconclusive.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
60 %
No. with + reactions:
1
Total no. in group:
10
Clinical observations:
1/10 animals showed slight, patchy erythema on the right flank only
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 60 %. No with. + reactions: 1.0. Total no. in groups: 10.0. Clinical observations: 1/10 animals showed slight, patchy erythema on the right flank only.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
60 %
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 60 %. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
60 %
No. with + reactions:
1
Total no. in group:
10
Clinical observations:
1/10 animals showed slight, patchy erythema on the left flank only
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 60 %. No with. + reactions: 1.0. Total no. in groups: 10.0. Clinical observations: 1/10 animals showed slight, patchy erythema on the left flank only.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
60 %
No. with + reactions:
2
Total no. in group:
20
Clinical observations:
2/20 animals showed slight, patchy erythema on the left flank only
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 60 %. No with. + reactions: 2.0. Total no. in groups: 20.0. Clinical observations: 2/20 animals showed slight, patchy erythema on the left flank only.
Reading:
other: 3rd reading
Hours after challenge:
72
Group:
negative control
Dose level:
60%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: other: 3rd reading. . Hours after challenge: 72.0. Group: negative control. Dose level: 60%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
other: 3rd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
60%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: other: 3rd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 60%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
25%
No. with + reactions:
5
Total no. in group:
20
Reading:
rechallenge
Hours after challenge:
24
Group:
positive control
Dose level:
25%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: no conclusive sensitisation reactions

Skin rections, induction phases

The 3rd induction with a 70% solution caused slight skin irritation in 2/20 treatment animals.

Skin reactions, challenge phase

At the first reading, 1/10 control animals had slight, patchy erythema on the challenge site on the left flank. 1/10 in the control group had slight, patchy erythema on the right flank at the second reading, while 2/20 treatment animals had slight, patchy erythema on the left flank at the second reading. All skin irritation effects had cleared within 72 hours after exposure ended.

Table 1: Skin reactions 24, 48 and 72 hours after challenge

 

24 hours

48 hours

72 hours

group

(# of animals)

flank

control

(10)

l/r

treatment

(20)

l/r

control

(10)

l/r

treatment

(20)

l/r

control

(10)

l/r

treatment

(20)

l/r

none

10/9

20/20

9/10

18/20

10/10

20/20

slight

0/1

0/0

1/0

2/0

0/0

0/0

weak

0/0

0/0

0/0

0/0

0/0

0/0

moderate

0/0

0/0

0/0

0/0

0/0

0/0

strong

0/0

0/0

0/0

0/0

0/0

0/0

l: left flank, induction site and challenge site

r: right flank, challenge site

Mortality and body weight

There was no mortality during the study period and the animals in the treatment group showed a similar gain in body weight compared with the control group.

Interpretation of results:
not sensitising
Conclusions:
Based on the reported observations the test substance is regarded as not sensitising.
Executive summary:

Testing for sensitising properties of octadec-9-en-1yl docos-13-enoate (CAS No 17673 -56 -2), a structural analogue, was performed in female guinea pigs according to the Bühler Method.Topical induction with 70% substance in peanut oil. The challenge was carried out with 60% test substance (epidermal).

Based on the reported observations the test substance is regarded as not sensitising.

Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Study period:
26 May - 23 Jun 2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
REPORTING FORMAT FOR THE ANALOGUE APPROACH
Please refer to cread across justification justification setcion 13.2

1. HYPOTHESIS FOR THE ANALOGUE APPROACH
Please refer to cread across justification justification setcion 13.2

2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
Please refer to cread across justification justification setcion 13.2

3. ANALOGUE APPROACH JUSTIFICATION
Please refer to cread across justification justification setcion 13.2

4. DATA MATRIX
Please refer to cread across justification justification setcion 13.2
Reason / purpose for cross-reference:
read-across source
Positive control results:
A reliability check with a positive control substance was performed every 6 months to demonstrate that the LLNA test system, as used by the test laboratory, is reliable and sufficiently sensitive. In the test performed in April 2010 (project No. 494039), 5, 10 and 25% alpha-hexylcinnamaldehyde, technical grade in acetone/olive oil (4:1 v/v) was used as the positive control. The SI values calculated for the substance concentrations 5, 10 and 25% were 1.7, 2.7 and 8.8 respectively. The SI-value for the vehicle control was 1.0. An EC3 value of 10.7% was calculated using linear interpolation. The calculated EC3 value was found to be in the acceptable range of 2 and 20%. The results of the 6 -monthly HCA reliability checks in CBA/J female mice of the recent years were 14.1, 13.8, 13.9, 16.0, 11.9 and 16.9%. Based on the results, it was concluded that the Local Lymph Node Assay in the mouse as supplied by Janvier performed at NOTOX is an appropriate model for testing for contact hypersensitivity.
Key result
Parameter:
SI
Value:
1.2
Test group / Remarks:
25% test item
Key result
Parameter:
SI
Value:
2
Test group / Remarks:
50% test item
Key result
Parameter:
SI
Value:
2.1
Test group / Remarks:
100% test item

Effects on the lymph nodes:

The right auricular node was enlarged in 1/5 mice in the highest dose group. As this was a single case, it is not considered to be a sensitivity reaction. No macroscopic abnormalitites were observed in the surrounding area.

Table 1: Individual values for radioactivity measurements (disintegrations per minute) and mean stimulation indices

Group

Animal No.

Concentration (% w/w)

DPM/animal

Stimulation index (mean± SEM)

1

1

0

480

-

 

2

0

629

-

 

3

0

367

-

 

4

0

447

-

 

5

0

515

-

Mean ± SEM

 

 

488 ± 43

1.0 ± 0.1

 

 

 

 

 

2

6

25

514

-

 

7

25

516

-

 

8

25

519

-

 

9

25

817

-

 

10

25

491

-

Mean ± SEM

 

 

571 ± 62

1.2 ± 0.2

 

 

 

 

 

3

11

50

928

-

 

12

50

778

-

 

13

50

589

-

 

14

50

1084

-

 

15

50

1376

-

Mean ± SEM

 

 

951 ± 134

1.0 ± 0.3

 

 

 

 

 

4

16

100

637

-

 

17

100

796

-

 

18

100

1137

-

 

19

100

1013

-

 

20

100

1483

-

Mean ± SEM

 

 

1013 ± 146

1.1 ± 0.1

DPM = disintegrations per minute

SEM = standard error of the mean

Skin irritation effects:

Slight erythema was observed at the test site on both ears in 5/5 mice exposed to 100% test substance. This was not considered to have affected the activity of the lymph nodes.

Systemic effects:

There was no mortality. No clinical signs were observed during the study period and there were no effects on body weight.

Interpretation of results:
GHS criteria not met
Conclusions:
The test item was found to be not a skin sensitiser.
Executive summary:

The sensitization potential of decyl octadec-9-enoate, a structural analogue, was investigated according to OECD Guideline 429.

The test item concentrations choosen for the LLNA test were 25, 50 and 100 %.

No deaths occurred during the study period. Slight erythema was observed at the test site on both ears in 5/5 mice exposed to 100% test substance.

In this study Stimulation Indices of 1.2, 2.0 and 2.1 were determined with the test item at concentrations of 25, 50 and 100.0 % in Acetone:Olive oil, 4:1 (v/v). The test item was found to be not a skin sensitiser.

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

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Structural analogues of the registration substance did not show skin sensitising properties in the Local Lymph Node Assay according to OECD 429 and the Bühler Test according to OECD 406. Therefore, the registration substance does not have to be classified as a skin sensitiser.