Benzoic acid, C12-15-alkyl esters

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

16. Feb. 1979 - 27 Apr. 1979

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1979

Report date:

1979

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 406 (Skin Sensitisation)

GLP compliance:

no

Type of study:

Buehler test

Justification for non-LLNA method:

Historical study available for this endpoint so used on animal welfare grounds to avoid further testing

Test material

Test material information

Constituent 1

Reference substance name:

Benzoic acid, C12-15-alkyl esters

EC Number:

270-112-4

EC Name:

Benzoic acid, C12-15-alkyl esters

Cas Number:

68411-27-8

Molecular formula:

C19-22 H30-36 O2

IUPAC Name:

Benzoic acid, C12-15-alkyl esters

In vivo test system

Test animals

Species:

guinea pig

Strain:

not specified

Sex:

male

Details on test animals and environmental conditions:

TEST ANIMALS
- Source: Summit View Farm, Belvidere, New Jersey
- Weight at study initiation: 260 -352 g
- hair was removed from back and flanks by close clipping
- Diet: Wayne animal feed, ad libitum
- Water: ad libitum
- Acclimation: animals were conditioned prior to use

Study design: in vivo (non-LLNA)

Induction

Induction 1

Route:

epicutaneous, occlusive

Vehicle:

water

Induction 2

Concentration / amount:

Test material used in 10 % gravimetric aqueous suspension.

Challenge

Challenge 1

Route:

epicutaneous, occlusive

Vehicle:

water

Challenge 2

Concentration / amount:

Test material used in 10 % gravimetric aqueous suspension.

No. of animals per dose:

12

Details on study design:

RANGE FINDING TESTS: 4 animals for testing the primary irritation threshold using 50%, 25%, 10% and 5% v/v aqueous concentration; result: score 1 after 16h and 40h ; 10 % concentration was chosen as non-irritating for the main study

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 9
- Exposure period: 6 hours
- Test group: 12 animals
- Control group: -
- Site: along the dorsal midline of the back, area 3-4 cm2
- Frequency of applications: three times weekly
- Duration: 3 weeks
- Concentrations: 0.5 ml of 10% gravimetric aqueous test material; 3" x 3" gauze pad wetted with test solution

B. CHALLENGE EXPOSURE
- No. of exposures: 1 (two applications to determine local and systemic effects
- Day(s) of challenge: two weeks after the last induction application
- Exposure period: 6 hours
- Site: along the dorsal midline of the back (for evaluation of topical effects) as well as ventrally (for evaluation of systemic effects)
- Concentrations: 0.5 ml of 10% gravimetric aqueous test material; 3" x 3" gauze pad wetted with test solution
- Evaluation (hr after challenge): 6 h und 24 h

Positive control substance(s):

not specified

Results and discussion

In vivo (non-LLNA)

Results

Results 1

Reading:

1st reading

Hours after challenge:

6

Group:

test chemical

Dose level:

10 %

No. with + reactions:

0

Total no. in group:

12

Clinical observations:

no topical (Draize scale 0-4) effects: score 0 and no systemic effects

Remarks on result:

other: Reading: 1st reading. . Hours after challenge: 6.0. Group: test group. Dose level: 10 %. No with. + reactions: 0.0. Total no. in groups: 12.0. Clinical observations: no topical (Draize scale 0-4) effects: score 0 and no systemic effects.

Results 2

Reading:

2nd reading

Hours after challenge:

24

Group:

test chemical

Dose level:

10 %

No. with + reactions:

0

Total no. in group:

12

Clinical observations:

no topical (Draize scale 0-4) effects: score 0 and no systemic effects

Remarks on result:

other: Reading: 2nd reading. . Hours after challenge: 24.0. Group: test group. Dose level: 10 %. No with. + reactions: 0.0. Total no. in groups: 12.0. Clinical observations: no topical (Draize scale 0-4) effects: score 0 and no systemic effects.

Results 3

Group:

negative control

Remarks on result:

not measured/tested

Results 4

Group:

positive control

Remarks on result:

not measured/tested

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test substance (10 % aqueous suspension as non-irritating concentration) showed no positive reactions after topical challenge and no positive reactions after systemic challenge in the Guinea Pig Sensitisation Test (Buehler). Under the conditions of this test the test substance is not a sensitiser.

Executive summary:

The study was performed to assess the skin sensitisation potential of the test material in a Guinea Pig Sensitisation Test using the Buehler method.

Twelve male guinea pigs (260 -352 g) were exposed to 9 topical, occluded applications (6 hours/day, 3 times weekly) over 21 day period and to two challenge applications 14 days later to determine local and systemic effects. A non-irritating concentration (10 % gravimetric aqueous suspension of the test material) was used. There were no positive reactions after topical challenge and no positive reactions after systemic challenge observed. Under the conditions of this test the test substance is not a sensitiser.