Registration Dossier
Registration Dossier
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EC number: 271-434-8 | CAS number: 68555-58-8
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1983
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 983
- Report date:
- 1983
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 1981
- GLP compliance:
- yes
Test material
- Reference substance name:
- 3-methyl-2-butenyl salicylate
- EC Number:
- 271-434-8
- EC Name:
- 3-methyl-2-butenyl salicylate
- Cas Number:
- 68555-58-8
- Molecular formula:
- C12H14O3
- IUPAC Name:
- 3-methylbut-2-en-1-yl 2-hydroxybenzoate
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: not specified
- Age at study initiation: not specified
- Weight at study initiation: about 2.5 kg
- Housing: individual cages
- Diet: laboratory standard diet for rabbits (Altromin/Lage)
- Water: ad libitum
- Acclimation period: not specified
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 °C ± 2 °C
- Humidity (%): 50 - 60 %
- Air changes (per hr): not specified
- Photoperiod (hrs dark / hrs light): 12 h/ 12 h
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 mL - Duration of treatment / exposure:
- 4 h
- Observation period:
- 7 days
- Number of animals:
- 5
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- % coverage: not specified
- Type of wrap: adhesive plaster
REMOVAL OF TEST SUBSTANCE
- Washing: yes
- Time after start of exposure: 4h
OBSERVATION TIME POINTS
1, 24, 48, 72 h, 7 days
SCORING SYSTEM:
- Method of calculation: Draize
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No indication of irritation after 1, 24, 48, 72 h or 7 days.
- Other effects:
- No indication to an incompatibility with the weight gains of untreated animals within the 7 days observation period.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In conclusion, it can be stated that in this study and under the experimental conditions reported, the test item is not irritant to skin.
- Executive summary:
A skin irritation test was performed according to OECD 404 and GLP. In the study 5 rabbits were exposed to 0.5 mL of the undiluted test substance for 4 hours. After removal of the test substance the test site (2.5 x 2.5 cm) was evaluated after 1, 24, 48, 72 hours and 7 days. The mean erythema and edema score for 24/48/72h and 7 days were 0. Due to these results the test substance was found to be not skin irritating and without classification at 100 %.
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