Reaction product of 2-Hexyldecan-1-ol, 2-Octyldodecan-1-ol and Lauric acid

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study according to OECD protocol no. 406 with acceptable restrictions, GLP compliant

Data source

Reference

Title:

Unnamed

Year:

1990

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 406 (Skin Sensitisation)

Deviations:

yes

Remarks:

no data on reliability check given

GLP compliance:

yes (incl. QA statement)

Type of study:

Freund's complete adjuvant test

Test material

Test material information

Constituent 1

Reference substance name:

135800-37-2

EC Number:

603-931-6

Cas Number:

135800-37-2

IUPAC Name:

135800-37-2

Details on test material:

- Name of test material (as cited in study report): 2-ethyl-hexylester with fatty acids C8-C14
- Physical state: clear liquid
- Analytical purity: 100%
- Lot/batch No.: 8 of 1990
- Expiration date of the lot/batch: May 1992
- Storage condition of test material: RT

In vivo test system

Test animals

Species:

guinea pig

Strain:

other: Pirbright white (Bor:DHPW)

Sex:

female

Study design: in vivo (non-LLNA)

Induction

Induction 1

Route:

intradermal and epicutaneous

Vehicle:

paraffin oil

Induction 2

Concentration / amount:

intradermal induction: 0.5% test substance plus Freund's adjuvants
epicutaneous induction: 40%
challenge: 20% test substance

Challenge

Challenge 1

Route:

epicutaneous, occlusive

Vehicle:

paraffin oil

Challenge 2

Concentration / amount:

intradermal induction: 0.5% test substance plus Freund's adjuvants
epicutaneous induction: 40%
challenge: 20% test substance

No. of animals per dose:

2 x 3 animals for preexperiments
10 control animals
20 "substance" animals

Results and discussion

In vivo (non-LLNA)

Results

Results 1

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

Dose level:

20%

No. with + reactions:

1

Total no. in group:

19

Clinical observations:

none

Remarks on result:

other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 20%. No with. + reactions: 1.0. Total no. in groups: 19.0. Clinical observations: none.

Results 2

Reading:

2nd reading

Hours after challenge:

48

Group:

test chemical

Dose level:

20%

No. with + reactions:

0

Total no. in group:

19

Clinical observations:

none

Remarks on result:

other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 20%. No with. + reactions: 0.0. Total no. in groups: 19.0. Clinical observations: none.

Any other information on results incl. tables

Pilot study:

Intradermal: Minimal irritation at 0.5% of the test article

Dermal: Minimal irritation at 40%

Main study:

Intracutaneous induction: After one hour, weak effects were observed at 7 of 20 treated animals and none of the control animals. 24 h after treatment, 11 of 20 treated animals showed weak effekts and again non of the control animals.

Epicutaneous induction: After one hour, weak up to moderate skin reactions were observed at 16 of 19 treated animals (one died after exposure) and at 7 of 10 control animals. 24 h later mostly weak effects were observed at 10 treated animals and at 2 of the control animals.

Challenge readings - grades of skin reaction of individual animals

 

Animal No.	Intracut. induction		Epicut. induction		Challenge
	1 h	24 h	1 h	24 h	24 h	48 h
Control Animals
27	0	0	1	0	1	0
28	0	0	1	0	1	0
29	0	0	1	0	0	0
30	0	0	1	0	0	0
31	0	0	0	0	1	0
32	0	0	2	1	0	0
33	0	0	1	1	1	0
34	0	0	0	0	1	1
35	0	0	0	0	0	0
36	0	0	1	0	0	0
Test Animals
1	0	0	2	1	0	0
2	1	0	2	0	0	0
3	0	1	1	0	0	0
4	1	1	1	1	0	0
5	1	1	1	0	0	0
6	0	1	1	0	0	0
7	1	1	0	0	0	0
8	0	0	1	1	0	0
9	1	1	-	-	-	-
10	0	0	1	0	0	0
11	0	0	0	0	0	0
12	0	1	2	1	0	0
13	0	0	0	0	0	0
14	0	0	0	0	0	0
15	1	0	0	0	0	0
16	0	1	2	2	1	0
17	0	0	1	1	0	0
18	0	1	2	2	0	0
19	0	1	0	0	0	0
20	1	0	1	1	0	0

One animal died after first exposure. No significant differences in the gain of body weight was observed between treatment and control group.

Applicant's summary and conclusion

Interpretation of results:

not sensitising

Remarks:

Migrated information

Executive summary:

The test substance was evaluated for its sensitization potential on the skin using a maximization method according to Magnusson and Kligman. In the test, 36 guinea pigs (strain Pirbright white) were used (2 x 3 for preexperiments, 20 "substance" and 10 control animals).

Preexperiments showed that 0.5 % or 40% of the substance was minimal irritating (intracutanous and epicutanous, respectively). The 20% substance was taken as non-irritating dose (epicutaneous) on the skin of guinea pigs. Paraffin perliquid DAB 8 was used always as vehicle.

After intracutanous and epicutanous (occlusive/48 h) application, using the minimal irritating concentrations of the substance, the retreatment was performed by application (occlusive/24 h) of the non-irritating concentration.

According to the test results obtained, the substance can be regarded as "non sensitizer" on the skin of guinea pigs.