Registration Dossier
Registration Dossier
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EC number: 236-425-5 | CAS number: 13361-34-7
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:
- 2 001
- Report date:
- 2002
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2-ethylhexyl cyanoacetate
- EC Number:
- 236-425-5
- EC Name:
- 2-ethylhexyl cyanoacetate
- Cas Number:
- 13361-34-7
- Molecular formula:
- C11H19NO2
- IUPAC Name:
- 2-ethylhexyl 2-cyanoacetate
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: 9-11 weeks
- Weight at study initiation: approx. 2 kg
- Housing: individually
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 10 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19°C +/- 2°C
- Humidity (%): 55% +/- 15%
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 04.03.2002 To: 08.03.2002
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: control site at the same animal
- Amount / concentration applied:
- 0.5 ml
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 1, 24, 48 and 72 hours after the end of the exposure period
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 6.25 cm2
- Type of wrap if used: gauze square, a strip of parafilm was placed and held in place with elastic adhesive bandage
REMOVAL OF TEST SUBSTANCE
- Washing: cotton wool soaked in water
- Time after start of exposure: 4 hours
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: 1-3
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal: 1-3
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- No irritation was apparent following a 4 hour period of exposure to the test item.
- Other effects:
- There was no indication of a systemic effect of treatment.
Any other information on results incl. tables
Changes in body weight during the course of the study were not remarkable.
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Remarks:
- Migrated information
- Conclusions:
- Under the conditions of this skin irritation study in the rabbit the test item is not irritant.
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