Registration Dossier
Registration Dossier
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EC number: 206-490-4 | CAS number: 349-76-8
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- June 1998
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- 1992
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 1992
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 3'-(trifluoromethyl)acetophenone
- EC Number:
- 206-490-4
- EC Name:
- 3'-(trifluoromethyl)acetophenone
- Cas Number:
- 349-76-8
- Molecular formula:
- C9H7F3O
- IUPAC Name:
- 1-[3-(trifluoromethyl)phenyl]ethan-1-one
- Test material form:
- liquid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Elevage Scientifique des Dombes, 01400 Chatillon sur Chalaronne, France
- Age at study initiation: ca. 2-3 months
- Weight at study initiation: approx. 2870-3000 g
- Housing: individual
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): between 50 +/- 20
- Air changes (per hr): 13-14
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.5 ml
- Duration of treatment / exposure:
- 4 h
- Observation period:
- 72 h (sufficient to determine reversibility)
- Number of animals:
- 3 males
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other:
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other:
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other:
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
Any other information on results incl. tables
Very slight erythema was observed in all animals at the 1-hour and 24-hour examination. At the 48-hour examination, very slight erythema was still detectable in two animals. All skin reactions were fully reversed within 72 hours after patch removal.
There was no mortality in the test.
There were no remarkable clinical observations.
Body weights were not affected by treatment.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Executive summary:
A dermal irritation/corrosion test according to OECD TG 404 was conducted with test article. The test article (0.5 ml) was applied to the shaved skin of three male rabbits for four hours under occlusive conditions. The test sites were examined for skin irritation at 1, 24, 48, and 72 hours after patch removal. Very slight erythema was observed in all animals at the 1-hour and 24-hour examination. At the 48-hour examination, very slight erythema was still detectable in two animals. All skin reactions were fully reversed within 72 hours after patch removal. There was no mortality, and there were no remarkable clinical observations.
Body weights were not affected by treatment.
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