Registration Dossier
Registration Dossier
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EC number: 241-972-8 | CAS number: 18063-03-1
Skin irritation / corrosion
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- other: Non-GLP, guideline study, available as unpublished report, no restrictions, fully adequate for assessment.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:
- 1 987
- Report date:
- 1987
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- no
Test material
- Reference substance name:
- 2,6-difluorobenzamide
- EC Number:
- 241-972-8
- EC Name:
- 2,6-difluorobenzamide
- Cas Number:
- 18063-03-1
- Molecular formula:
- C7H5F2NO
- IUPAC Name:
- 2,6-difluorobenzamide
- 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
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system 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.
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