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Toxicological information

Skin irritation / corrosion

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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:
2009
Report Date:
2009

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
other: OECD 402 'Acute Dermal Toxicity'
Qualifier:
according to
Guideline:
other: EU Method B.3
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
impurity
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 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.