Registration Dossier
Registration Dossier
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EC number: 700-476-6 | CAS number: 119895-68-0
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: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2,2-difluoro-2H-1,3-benzodioxole-4-carbaldehyde
- EC Number:
- 700-476-6
- Cas Number:
- 119895-68-0
- Molecular formula:
- C8H4F2O3
- IUPAC Name:
- 2,2-difluoro-2H-1,3-benzodioxole-4-carbaldehyde
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 2500 - 2600 g
- Housing: individually in metal cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 1992-06-09 To: 1992-07-17
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.5 mL of undiluted test material
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 10 days
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 12-16 cm2
- Type of wrap if used: gauze patch with test item, aluminium foil, adhesive tape
REMOVAL OF TEST SUBSTANCE
- Washing: no
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 24, 48 and 72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 1.44
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 days
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 days
- Irritant / corrosive response data:
- At the reading at 1 hour up to 72 hours the erythema reaction was extending beyond the application area in one animal. In the same animal a slight loss of body weight was observed on experimental day 3. In another animal slight scaling was seen on experimental day 7.
Because reactions were observed within 72 hours after removing the bandages, the observation period was extended to 10 days to determine the reversibility of the skin reactions. The observed skin reaction were reversible until the end of the observation period on day 10.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: other: EU GHS
- Conclusions:
- Under the conditions of this skin irritation study in the rabbit the test item was neither corrosive nor irritating to the skin.
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