Benzoic acid, 2-amino-5-fluoro-, methyl 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 with no or minor deficiencies.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2001

Report date:

2001

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 406 (Skin Sensitisation)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2600 (Skin Sensitisation)

Test guideline 3

Qualifier:

according to guideline

Guideline:

other: Commission Directive 96/54/EC Annex IV

GLP compliance:

yes (incl. QA statement)

Type of study:

guinea pig maximisation test

Test material

Test material information

Constituent 1

Reference substance name:

methyl 2-amino-5-fluorobenzoate

EC Number:

608-681-1

Cas Number:

319-24-4

Molecular formula:

C8 H8 F N O2

IUPAC Name:

methyl 2-amino-5-fluorobenzoate

Test material form:

other: yellow liquid

In vivo test system

Test animals

Species:

guinea pig

Strain:

other: HsdPoc:DH (Harlan)

Sex:

female

Details on test animals and environmental conditions:

12 hours light/dark cycle
Humidity: 50±20 %
Food: Ssniff, ad libitum
Water: tap water in plastic bottles

Study design: in vivo (non-LLNA)

Induction

Route:

intradermal

Vehicle:

unchanged (no vehicle)

Challenge

Route:

epicutaneous, occlusive

Vehicle:

unchanged (no vehicle)

Positive control substance(s):

yes

Results and discussion

Any other information on results incl. tables

DETERMINATION OF THE TOLERANCE OF THE INTRADERMAL INJECTIONS

Intradermal injections with the 5.0. 1.0 and the 0.2 % preparation caused clear edema and slight erythema. Based on this preliminary test, a 5.0 % preparation was selected for the intradermal injections in the main test.

DETERMINATION OF THE PRIMARY NON-IRRITATING CONCENTRATION

No signs of irritation occurred after administration of the different test concentrations.

Based on these results, a concentration of 100 % 2-Amino-5-fluorbenzoesaeuremethylester was chosen for the challenge at day 22.

MAIN TEST FOR THE SENSITIZING PROPERTIES

Body weight gains and clinical signs

The body weight gains of the animals were not impaired.

The treated animals showed no clinical signs of intoxication throughout the study.

Intradermal induction treatment

Intradermal injections with Freund's Adjuvant (with and without test substance) caused severe erythema and edema as well as indurations and encrustations. The administration sites treated with the test substance in sesame oil showed slight erythema and edema. Intradermal injections of the vehicle alone exhibited no signs of irritation.

Due to these strong irritation reactions of the skin, 10% sodium dodecylsulfate was not administered at day 7.

Dermal induction treatment

After the removal of the patches at day 10, severe erythema and edema, indurated, scabbed and encrusted skin as well as necrosis were observed at the sites previously treated with Freund's Adjuvant. The administration sites treated with the test substance or the vehicle alone showed no signs of irritation.

Dermal challenge treatment

No skin reactions were observed in the control and the treatment group 24 and 48 hours after removal of the occlusive bandage.

Applicant's summary and conclusion

Interpretation of results:

not sensitising

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the conditions of the present study, none of the ten animals showed a positive skin response after the challenge procedure.