Registration Dossier
Registration Dossier
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EC number: 206-735-5 | CAS number: 371-40-4
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1994-03-14 to 1994-03-27
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- Adopted: 12 May 1981
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 3,5-difluoroaniline
- EC Number:
- 206-752-8
- EC Name:
- 3,5-difluoroaniline
- Cas Number:
- 372-39-4
- Molecular formula:
- C6H5F2N
- IUPAC Name:
- 3,5-difluoroaniline
- Test material form:
- solid: crystalline
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Froxfield (U.K.) Ltd., Petersfield, Hampshire, England.
- Age at study initiation: 10--1 weeks
- Weight at study initiation: 2.3- 2.6 kg
- Housing: Individually in metal cages with perforated floors
- Diet: SDS Stanrab (P) Rabbit Diet, ad libitum
- Water: Drinking water, ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature: 19°C
- Humidity: 30-70 %
- Air changes: 19 air changes per hour
- Photoperiod: 12 hours light in each 24 hours period
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 g - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 14 days
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: Dorso-lumbar region
-Coverage area: 25 mm x 25 mm
- Type of wrap if used: Gauze pad, each treatment site was covered with "Elastoplast" elastic adhesive dressing
REMOVAL OF TEST SUBSTANCE
- Washing: Yes, warm water (30°C-40°C)
- Time after start of exposure: At the end of the exposure period.
SCORING SYSTEM:
Erythema and eschar formation:
No erythema: 0
Very slight erythema (barely perceptible): 1
Well-defined erythema: 2
Moderate to severe erythema: 3
Severe erythema (beet redness) to slight eschar formation (injuries in depth)preventing erythema reading: 4
Oedema formation:
No oedema: 0
Very slighr oedema (barely perceptible): 1
Slight oedema (edges of area weII-defined by definite raising): 2
Moderate oedema (raised approximately 1 millimetre): 3
Severe oedema (raised more than 1 millimetre and extending beyond the area of exposure): 4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 3.33
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days
- Remarks on result:
- other: Necrosis
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Remarks on result:
- other: Brown hardening of the skin
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Remarks on result:
- other: Necrosis
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Remarks on result:
- other: Brown hardening of the skin
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Remarks on result:
- other: Desquamation of the stratum corneum
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2.33
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Irritant / corrosive response data:
- Clinical signs:
There were no signs of toxicity or ill health in any rabbit during the observation period.
Dermal responses
Moderate to severe erythema with slight to moderate oedema was seen following removal of the dressings. On day 3 severe erythema with necrosis was seen. Necrotic reactions, brown hardening of the skin and desquamation of the stratum corneum was seen between day 6 and 14.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1C (corrosive)
- Remarks:
- Migrated information
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