2-Propenoic acid, 4-[[(4-benzoylphenoxy)carbonyl]oxy]butyl ester

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP and guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Report date:

1992

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EU Method B.6 (Skin Sensitisation)

Version / remarks:

Cited as Directive 84/449/EEC, B.6

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Type of study:

guinea pig maximisation test

Test material

Test material information

Constituent 1

Reference substance name:

4-{[(4-benzoylphenoxy)carbonyl]oxy}butyl prop-2-enoate

EC Number:

603-491-5

Cas Number:

131513-00-3

Molecular formula:

C21H20O6

IUPAC Name:

4-{[(4-benzoylphenoxy)carbonyl]oxy}butyl prop-2-enoate

In vivo test system

Test animals

Species:

guinea pig

Strain:

other: Pirbright White and Dunkin Hartley

Sex:

female

Details on test animals and environmental conditions:

TEST ANIMALS
- Source: Lippische Versuchstierzucht, Hagemann GmbH & Co. KG, D-W4923 Extertal 1, Germany
- Age at study initiation: young adult animals
- Weight at study initiation: 311-347 g
- Housing: 5 animals per cage (Makrolon, type IV)
- Diet: Kliba 341.4 mm (standardized diet), ad libitum
- Water: tap water ad libitum; about 2 g of ascorbic acid per10 L water was added to the drinking water twice a week
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature: 20 - 24°C in fully air conditioned rooms
- Humidity: 30-70 %
- Photoperiod (hrs dark / hrs light): 12 h / 12 h

Study design: in vivo (non-LLNA)

Induction

Induction 1

Route:

other: intradermal and percutaneous

Vehicle:

olive oil

Induction 2

Concentration / amount:

intradermal induction: 5%
percutaneous induction: 50%
challenge: 25%

Challenge

Challenge 1

Route:

intradermal and epicutaneous

Vehicle:

olive oil

Challenge 2

Concentration / amount:

intradermal induction: 5%
percutaneous induction: 50%
challenge: 25%

No. of animals per dose:

5 animals in control group 1, 5 animals in control group 2, test group: 10 animals

Details on study design:

RANGE FINDING TESTS:
1 pretest was conducted using 4 animals per concentration. In the preliminary test after two 24-hour percutaneous occlusive applications within 96 hours the minimum irrtitant concentration was found to be a 50 % test substance preparation in olive oil DAB 9 and the maximum nonirritant concentration a 25 % test substance preparation in olive oil DAB 9.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Exposure period: single treatment
- Test groups: 6 intradermal injections (exposure 1) and 1 percutaneous induction (exposure 2)
- Control group: The animals were given the same injections (A, B, C) but without test substance, only with the formulating agent, and the same percutaneous induction but only with the solvent without the test substance.
- Site: shoulder
- Duration: duration of percutaneous exposure: 48 h
- Concentrations: Injections: test substance 5 % in olive oil DAB 9, resp. in Freund's adjuvant/0,9 % aqueous NaCl solution (1:1) resp. olive
oil DAB 9
Percutaneous induction: test substance 50 % in olive oil DAB 9

B. CHALLENGE EXPOSURE
- No. of exposures:1
- Exposure period: 24 h
- Test groups: treatment of the test group and of control group 1 with the test substance formulation. Additionally olive oil DAB 9 was applied as a vehicle.
- Control group: Control group 2 only received olive oil DAB 9.
- Site: intact clipped flank
- Concentrations: test substance 25 % in olive oil DAB 9 resp. olive oil DAB 9
- Evaluation (hr after challenge): 24 and 48

Positive control substance(s):

yes

Remarks:

1-chlor-2,4-dinitro-benzol

Results and discussion

In vivo (non-LLNA)

Results

Results 1

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

Dose level:

25%

No. with + reactions:

10

Total no. in group:

10

Remarks on result:

other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 25%. No with. + reactions: 10.0. Total no. in groups: 10.0.

Results 2

Reading:

1st reading

Hours after challenge:

24

Group:

negative control

Dose level:

0 %

No. with + reactions:

0

Total no. in group:

5

Remarks on result:

other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0 %. No with. + reactions: 0.0. Total no. in groups: 5.0.

Results 3

Reading:

2nd reading

Hours after challenge:

48

Group:

test chemical

Dose level:

25 %

No. with + reactions:

7

Total no. in group:

10

Remarks on result:

other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25 %. No with. + reactions: 7.0. Total no. in groups: 10.0.

Results 4

Reading:

2nd reading

Hours after challenge:

48

Group:

negative control

Dose level:

0 %

No. with + reactions:

0

Total no. in group:

5

Remarks on result:

other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0 %. No with. + reactions: 0.0. Total no. in groups: 5.0.