Butyl O-acetylricinoleate

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

secondary literature

Justification for type of information:

Data is from secondary source.

Data source

Reference

Reference Type:

secondary source

Title:

Straight Chain Lepidopteran Pheromones (SCLPs) Group - DAR - Vol. 3 - Annex B.6 - Part 2

Author:

European Food Safety Authority (EFSA)

Year:

2008

Bibliographic source:

EFSA ,Draft Assessment Report (DAR), STRAIGHT CHAIN LEPIDOPTERAN PHEROMONES (SCLP) of the fourth stage of the review programme referred to in Article 8(2) of Council Directive 91/414/EEC Volume 3, Annex B, part 2/B, B.6, September 2008

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 406 (Skin Sensitisation)

Principles of method if other than guideline:

The skin sensitization study (7E, 9Z)-dodecadienyl acetate was performed in guinea pig by Guinea pig maximization test

GLP compliance:

not specified

Type of study:

guinea pig maximisation test

Justification for non-LLNA method:

Not specified.

Test material

Test material information

Constituent 1

Reference substance name:

(7E,9Z)-dodecadienyl acetate

EC Number:

259-127-7

EC Name:

(7E,9Z)-dodecadienyl acetate

Cas Number:

54364-62-4

Molecular formula:

C14H24O2

IUPAC Name:

dodeca-1,3-dien-1-yl acetate

Test material form:

not specified

Specific details on test material used for the study:

Details on test material
- Name of test material (as cited in study report): (7E, 9Z)-Dodecadien-l-yl Acetate BAS288…..I
- Molecular formula:C14H24O2
- Molecular weight: 224.341g/mole
- Substance type: organic
- Physical state: No data available
- Purity: 81.3%
- Lot/batch No.:24623/45

In vivo test system

Test animals

Species:

guinea pig

Strain:

other: Pirbright white , DunkinHartley HOE DHPK (SPF-LAC)BO

Sex:

not specified

Details on test animals and environmental conditions:

Details on test animal
TEST ANIMALS
- Source: Lippische Versuchstierzucht. Hagemann GmbH & Co. KG. W4923 Exertal 1. FAG, Germany.
- Age at study initiation: Young adult
- Weight at study initiation:270-348g
- Housing: No data available
- Diet (e.g. ad libitum): No data available
- Water (e.g. ad libitum): No data available
- Acclimation period: No data available

ENVIRONMENTAL CONDITIONS
- Temperature (°C): No data available
- Humidity (%):No data available
- Air changes (per hr): No data available
- Photoperiod (hrs dark / hrs light): No data available

Study design: in vivo (non-LLNA)

Induction

Route:

intradermal and epicutaneous

Vehicle:

other: Olive oil DAB 9

Concentration / amount:

For intradermal injection :0.1ml FCA , 5% test substance in olive oil DAB9 and test substance formulation in FCA
For epicutaneous application : 0.3 g of test substance 75% test substance in olive oil DAB 9

Day(s)/duration:

For intradermal injection:24hr For epicutaneous application:48hr

Challenge

No.:

#1

Route:

epicutaneous, occlusive

Vehicle:

other: Olive oil DAB 9

Concentration / amount:

0.15 g test substance formulation (50%test substance in vehicle)

Day(s)/duration:

24hr

No. of animals per dose:

Total:50
Test group:20
Control group:10
Positive control group:20

Details on study design:

Details on study design
RANGE FINDING TESTS:Pretests were conducted to determine the dose levels used in induction and challenge.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Exposure period: For intradermal injection:24hr
For epicutaneous application:48hr
- Test groups:20
- Control group: 10
- Site: No data available
- Frequency of applications: one week after intra dermal injection
- Duration: For intradermal injection:24hr
For epicutaneous application:48hr
- Concentrations: For intradermal injection :0.1ml FCA , 5% test substance in olive oil DAB9 and test substance formulation in FCA
For epicutaneous application : 0.3 g of test substance 75% test substance in olive oil DAB 9

B. CHALLENGE EXPOSURE
- No. of exposures: one
- Day(s) of challenge: 21 days after intradermal injection
- Exposure period: 24hr
- Test groups:20
- Control group: 10
- Site: two different site
- Concentrations: 0.15 g test substance formulation (50%test substance in vehicle)
- Evaluation (hr after challenge): 24hr and 48hr

Challenge controls:

Yes

Positive control substance(s):

yes

Remarks:

1-chlor-2,4-dinitro-benzol (1% test substance preparation

Study design: in vivo (LLNA)

Statistics:

No data available

Results and discussion

In vivo (non-LLNA)

Results

Reading:

1st reading

Hours after challenge:

48

Group:

test chemical

Dose level:

0.15 g test substance formulation (50%test substance in vehicle)

No. with + reactions:

0

Total no. in group:

20

Clinical observations:

There were no dermal effects noted in treated animals after Induction Phases or at challenge

Remarks on result:

no indication of skin sensitisation

Applicant's summary and conclusion

Interpretation of results:

other: Not sensitizing

Executive summary:

The skin sensitization study of Dodeca-1,3-dien-1-yl acetatewas performed  by Guinea pig maximization test usingPirbright white , DunkinHartley HOE DHPK (SPF-LAC)BO guinea pig .10 animals in control group and 20 animals in test group were used also 20 animals used as positive control group.

In a pre-test, 0.15 g of testsubstance formulationwas applied to the skin of 4 guinea pigs under occlusive conditions for 24hr within period of 96hr observation done after 24 and 48hr after application.

In induction phase ,For intradermal injection :0.1ml FCA , 5% test substance in olive oil DAB9 and test substance formulation in FCA were used ,after 24hr reading was noted .after one week epicutaneous application of 0.3 g of test substance ( 75% test substance in olive oil DAB 9)was applied for 48 hr as occlusive patch. Reading noted after 48 hr.

In challenge phase, 21 days after intradermal injection0.15 g test substance formulation(50%test substance in vehicle) was applied at two different site for a period of 24hr .reading were performed after 24 and 48hr after removal of patch .In addition, a positive control group of 20 animals was treated with 1-chlor-2,4-dinitro-benzol (1% test substance preparation) using the same procedures described for the test group.

After intradermal injection of FCA, test substance formulation or test substance formulation in FCA gave rise to well-defined erythema (grade 2) and slight oedema (grade 2) in all animals. In challenge phase no skin sensitization observed in any animal .In positive control group,2/20 animals exhibited moderate to severe erythema (grade 3), 14/20 animals showed well-defined erythema (grade 2) and very slight erythema (grade 1) were found in 4/20 animals. In addition, 13/20 animals showed very slight oedema. From above finding it is considered that Dodeca-1,3-dien-1-yl acetatewas  considered to benot skin sensitizing in guinea pig.