Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Non-GLP, guideline study, available as unpublished report, no restrictions, fully adequate for assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report Date:
1987

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
Batch number: 722.35
ST number: ST86/206
Characterisation: no purity data available- commercial sample
Appearance: white powder

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Sittingbourne Research Centre Breeding unit
- Age at study initiation: 4 to 9 months
- Weight at study initiation: 4.4 kg (males) and 4.1 kg (females)
- Housing: single in hanging, stainless-steel cages with all-mesh floors and tops and half-mesh fronts; each cgae measured 67 x 43 x 45 cm
- Diet: Standard Rabbit Diet (S.Q.C., Special Diet Service Ltd., Essex, UK), ad libitum
- Water: ad libitum
- Acclimation period: at least two weeks

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16-19
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 500 mg powder moistened with water
Duration of treatment / exposure:
4 hours after which the test site was washed with water
Observation period:
30 minutes, 24, 48 and 72 hours and 7 days after patch removal
Number of animals:
3 males and 3 females
Details on study design:
TEST SITE
- Area of exposure: 2 x 2 cm patch
- Type of wrap if used: single layer of gauze, fixed with an elastic adhesive bandage

REMOVAL OF TEST SUBSTANCE
- Washing: with water and gently dried
- Time after start of exposure: 4 h

SCORING SYSTEM: according to OECD guideline

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: not applicable; no skin reactions
Remarks on result:
other: 30 minutes and 7 days after patch removal the erythema score was also 0
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: not applicable; no skin reactions
Remarks on result:
other: 30 minutes and 7 days after patch removal the edema score was also 0
Irritant / corrosive response data:
There were no skin reactions following the application of the test item for 4 hours to rabbit skin.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
There were no skin reactions following the application of 2,6-difluorobenzamide powder for 4 hours to rabbit skin. The test material is therefore
not a skin irritant.
Executive summary:

In a skin irritation test according to OECD guideline 404, 500 mg of 2,6-difluorobenzamide was applied to 2 cm x 2cm of the skin of New Zealand White rabbits (3/sex) as a moistened powder for 4 hours under semi-occlusive conditions after which the substance was removed by washing (Sittingbourne Research Centre, 1987). Observations were done at 30 minutes, 24, 48 and 72 hours and 7 days after patch removal. The erythema and edema scores were 0 on a scale of 0 to 4 for each observation time point. The substance was judged as being not irritating to skin.