Registration Dossier
Registration Dossier
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EC number: 299-682-2 | CAS number: 93893-89-1
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2007-02-13 to 2007-02-14
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 2002
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- 2004
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 3-methyl-5-phenylpent-2-enenitrile
- EC Number:
- 299-682-2
- EC Name:
- 3-methyl-5-phenylpent-2-enenitrile
- Cas Number:
- 93893-89-1
- Molecular formula:
- C12 H13 N
- IUPAC Name:
- (2E)-3-methyl-5-phenylpent-2-enenitrile
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 12-20 weeks
- Weight at study initiation: 2-3.5 kg
- Housing: individually
- Diet: certified rabbit food, ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23
- Humidity (%): 30-70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 mL - Duration of treatment / exposure:
- One animal was initially treated with three patches, one patch was removed at each of the three time points 3 min, 1 h and 4 h. Two additional animals were treated afterwards and the patches were removed after 4 hours.
- Observation period:
- Test sites were observed after 1, 24, 48 and 72 hours.
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: dorsal/flank area
- Type of wrap if used: elasticated corset
REMOVAL OF TEST SUBSTANCE
- Washing: Any residual test material was removed by swabbing with cotton wool soaked in distilled water.
- Time after start of exposure: directly after removal of the patch
SCORING SYSTEM:
Erythema and oedema formation were scored according to a 5 graded scale (0-4) each.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- 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
- 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
- Remarks on result:
- no indication of irritation
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test material was not irritating to the rabbits' skin.
- Executive summary:
A study according to OECD Guideline No. 404 was conducted to assess the irritating properties of the test substance when applied to rabbits’ skin. Three male New Zealand White rabbits were used. 0.5 mL of the undiluted test item were applied to clipped skin sites under semi-occlusive conditions. The first animal was exposed for 3 min, 1 hour and 4 hours and based on the skin findings the remaining two animals were exposed for 4 hours afterwards. After patch removal, the skin sites were examined after 1, 24, 48 and 72 hours. No signs of erythema/eschar or oedema formation was observed. Based on these results, the test material was considered to be non-irritating to skin.
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