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Diss Factsheets

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP guideline study with acceptable restrictions (purity: 76%)
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes
Type of study:
Buehler test
Justification for non-LLNA method:
Valid study report available before REACh came into force, therefore no new LLNA test was performed.
Species:
guinea pig
Strain:
Hartley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Elm Hill Breeding Labs, Chelmsford, Massachusetts, USA
- Age at study initiation: young adults
- Weight at study initiation: 382 - 508 g
- Housing: group housed in suspended stainless steel caging
- Diet: Pelleted Purina Guinea Pig Chow #5025, ad libitum
- Water: tap water, ad libitum
- Acclimation period: 19 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 23
- Photoperiod (hrs dark / hrs light): 12/12
Route:
epicutaneous, occlusive
Vehicle:
other: mineral oil
Concentration / amount:
- Induction: 100%
- Challenge: 75%
Route:
epicutaneous, occlusive
Vehicle:
other: mineral oil
Concentration / amount:
- Induction: 100%
- Challenge: 75%
No. of animals per dose:
- Preliminary irritation group: 4
- Test group: 20
- Test naive control group: 10
Details on study design:
RANGE FINDING PRETEST
A group of animals was used to determine the highest non-irritating concentration (HNIC) of the test substance to establish the challenge dose. The fur was removed by clipping (Oster model #A5-small) the dorsal area and flanks of each guinea pig. This area was divided into four test sites (two sites on each side of the midline) on each animal. The test substance was applied neat (100%) and also diluted with mineral oil to yield concentrations of 75%, 50% and 25% w/w. Each concentration was applied to a test site using an occlusive 25 mm Hilltop Chamber. The sites were wrapped with non-allergenic Durapore adhesive tape. After 6 hours of exposure, the chambers were removed and the test sites were cleaned. Approximately 24 hours after application, each site was evaluated for local reactions (erythema). Based on the observed results, a concentration of 75% was defined as HINC used for challenge (in 4 guinea pigs, 2/4 animals showed local skin reactions scored with 0.5 and the remaining animals were free of local effects (score 0)).

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 h (after every exposure period the test sites were cleaned of residual test substance).
- Test groups: 20 animals, treated with test item
- Site: left side
- Frequency of applications: Once each week for three weeks.
- Duration: 3 weeks
- Concentrations: 100%
- Pretreatment: On the day before initiation, the fur of a group of animals was removed by clipping the dorsal area and flanks.

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 27 days after the first induction dose
- Exposure period: 24 h
- Test groups: 20 animals, treated with test item
- Control group: 10, treated with test item
- Site: naive site on the right side
- Concentrations: 75%
- Evaluation (hr after challenge): 24 and 48 h
Challenge controls:
In addition to the test animals, 10 guinea pigs from the same shipment were maintained under identical environmental conditions and were treated with the HNIC of the test substance at challenge only. These animals constituted the "naive" group.
Positive control substance(s):
yes
Remarks:
alpha-Hexylcinnamaldehyde, technical grade (85% active ingredient)
Positive control results:
periodically tested, last test with acceptable level of response: September 6, 2002
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
induction: neat substance; challenge: 75%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
Very faint erythema (score 0.5) were observed in 12/20 test animals.
Remarks on result:
other: see Remark
Remarks:
Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: induction: neat substance; challenge: 75%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: Very faint erythema (score 0.5) were observed in 12/20 test animals..
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
challenge: 75%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
Very faint erythema (score 0.5) were observed in 7/10 naive control animals.
Remarks on result:
other: see Remark
Remarks:
Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: challenge: 75%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: Very faint erythema (score 0.5) were observed in 7/10 naive control animals..
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
induction: neat substance; challenge: 75%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
none
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: induction: neat substance; challenge: 75%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
challenge: 75%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: challenge: 75%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.

Individual challenge readings:

Animal No.

Hours after Dosing

24

48

Test Group

1

0

0

2

0.5

0

3

0

0

4

0

0

5

0.5

0

6

0.5

0

7

0

0

8

0.5

0

9

0

0

10

0.5

0

11

0.5

0

12

0.5

0

13

0.5

0

14

0.5

0

15

0.5

0

16

0.5

0

17

0.5

0

18

0

0

19

0

0

20

0

0

Test Naive Control Group

1

0.5

0

2

0.5

0

3

0.5

0

4

0.5

0

5

0

0

6

0.5

0

7

0

0

8

0

0

9

0.5

0

10

0.5

0

Historical Positive Control Validation Study

Positive Control

1

0.5

0.5

2

1

1

3

0.5

0.5

4

0.5

0

5

0.5

0.5

6

0.5

0.5

7

0.5

0.5

8

0.5

0

9

1

0.5

10

1

0.5

Naive Control

1

0.5

0.5

2

0.5

0.5

3

0.5

0.5

4

0

0

5

0.5

0.5

After challenge with the test substance, the sensitisation rate at 24 h and 48 h was 0%.

No deaths occurred. No significant difference in body weight gain was observed between treated and control group.

Regarding the historical positive controls, the sensitisation rate at 24 h was 30% and at 48 h 10%. This result validates the test system used in this study.

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not classified
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

Sensitisation

There are data regarding skin sensitisation available for Fatty acids, C18 unsaturated, ethyl & methyl esters.

A Buehler Test was performed with EC 941-981-3 (purity: 76%) according to OECD Guideline 406 (Wnorowski, 2003). 20 male and female Hartley guinea pigs were treated with the test substance and compared with 10 naive control animals. In a range-finding study a 75% dilution of the test substance in mineral oil was found to be the maximally non-irritating test substance concentration. Three epidermal inductions were performed with undiluted test substance in weekly intervals for 6 hours under occlusive conditions. 27 days after the first induction treatment, all animals were challenged for 24 hours epicutaneously with 75% test substance diluted in mineral oil under occlusive conditions. 24 h after challenge 12/20 test animals and 7/10 negative control animals showed weak dermal reactions which recovered 48 h after challenge. Thus, the test substance itself was proven to be a non-sensitizer on the skin of guinea pigs. A positive control group treated with alpha-Hexylcinnamaldehyde was included in the study and proved the validity of the test.

 

Conclusion on skin sensitising properties

The available data point to non-sensitising properties of Fatty acids, C18 unsaturated, ethyl & methyl esters. Thus, Fatty acids, C18 unsaturated, ethyl & methyl esters is not considered as skin sensitiser.


Migrated from Short description of key information:
No sensitsing potential (OECD 406 (Buehler)).

Justification for selection of skin sensitisation endpoint:
The reliable GLP compliant OECD Guideline study was taken.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

The available data on skin sensitisation do not meet the classification criteria according to Regulation (EC) 1272/2008 and are therefore conclusive but not sufficient for classification.