Registration Dossier
Registration Dossier
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EC number: 273-960-3 | CAS number: 69300-15-8
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: OECD 402 'Acute Dermal Toxicity'
- Qualifier:
- according to guideline
- Guideline:
- other: EU Method B.3
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 2-methyldecanenitrile
- EC Number:
- 273-960-3
- EC Name:
- 2-methyldecanenitrile
- Cas Number:
- 69300-15-8
- Molecular formula:
- C11H21N
- IUPAC Name:
- 2-methyldecanenitrile
- Reference substance name:
- Unknown impurities
- Molecular formula:
- Unknown
- IUPAC Name:
- Unknown impurities
Constituent 1
impurity 1
- Specific details on test material used for the study:
- Identification: Frutonile
Description: Liquid
Batch Number: VE00002027 or 9000774502
Expiry Date: 19-Oct-2009
Storage conditions: At room temperature (range 20 +/- 5 °C, provided by Harlan Laboratories Ltd.), light protected.
Safety Precautions: Routine hygenic procedures (gloves, laboratory overall, goggles, fask mask). A full filtered, positive air-supplied respirator will be used during the inhalation process.
Test animals
- Species:
- rat
- Strain:
- Wistar
- Details on test animals or test system and environmental conditions:
- Animals: Rat, HsdHan: WIST (SPF)
Rationale: Recognized by international guidelines as recommended test system
Breeder: Harlan Laboratories B.V.
Number of Animals per grop: 5 males and 5 females
Age: Males (10 weeks), Females (12 weeks)
Body Weight range (when treated): 242.0 g - 281.5 g (females), 191.4 g - 220.8 g (males)
Identification: Unique cage number and corresponsing color-coded spots on the tail. The animals were marked at acclimatization start.
Randomization: Selected by hand at time of delivery. No computer generated randomization program.
Acclimatization: Under laboratory conditions, after health examination. Only animals without any visible signs of illness were used for the study.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- other: corn oil
- Controls:
- no
- Amount / concentration applied:
- Application volume/kg body weight: 4 ml
- Duration of treatment / exposure:
- One day before treatment, the backs of the animals were clipped with an electric clipper, exposing an area of approximately 10% of the total bosy surface. Only animals without injury or irritation to the skin were used in the test. On day one, the test item was applied at a dose of 2000 mg/kg body weight evenly on the intact skinwith a syringe and covered with a semi-occlusive dressing. The dressing was wrapped around the abdomen and fixed with an elastic adhesive bandage.
Application volume/kg body weight: 4 ml
Twenty-four hours after the application the dressing was removed and the skin was flushed with lukewarm tap water and drapped off with disposable paper towels. Thereafter, the reaction sites were assessed.
All animals were re-shaved on test days 8 and 15 to facilitate the reading of teh local reactions - Observation period:
- 14 days
- Number of animals:
- 5 animals per sex per dose
Results and discussion
In vivo
Results
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritant / corrosive response data:
- Under the conditions of the study, very slight erythema was observed in all ten animals after removal of the application patch on test day 2 and persisted up to test days 6 or 7. Thereafter, all animals were free of local signs up to day 15, the end of the observation period.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of the study, very slight erythema was observed in all ten animals after removal of the application patch on test day 2 and persisted up to test days 6 or 7. Thereafter, all animals were free of local signs up to day 15, the end of the observation period.
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