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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
Study period:
2007-03-14 to 2007-03-22
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
GLP study performed according to OECD Guideline 404 (Acute Dermal Irritation / Corrosion) and EU Method B.4 (Acute Toxicity: Dermal Irritation) without deviation.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report Date:
2007

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
Certificate issued by the Swiss GLP Monitoring Authorities

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Details on test material:
- Name of test material (as cited in study reports): T002675, TIC876
- Physical state: liquid
- Appearance: colorless to yellowish liquid
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 603T-1
- Expiration date of the lot/batch: 2007-12-19
- Purity test date: no data
- Purity: 97.76%

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: at room temperature (range of 20 ± 5 °C, provided by RCC), light protected.
- Stability under test conditions: no data

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Test item was applied undiluted as it was delivered by the sponsor.

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: 3 male and 3 female young adult New Zealand White Rabbit, SPF; Harland Netherlands BV, Kreuzelweg 53, NL-5961 NM Horst, The Netherlands/Postbus 6174, NL-5960 AD Horst, The Netherlands
- Age at study initiation: 12-13 weeks for males; 11-13 weeks for females
- Weight at study initiation: 2150-2386 g
- Housing: standard laboratory conditions; individually in stainless steel cages with feed hoppers and drinking water bowls. Wood blocks and haysticks 4642 batch 08/07 were provided for gnawing.
- Diet (e.g. ad libitum): pelleted standard Provimi Kliba 3418 rabbit maintenance diet (batch 83/06 and 01/07), ad libitum
- Water (e.g. ad libitum): Füllinsdorf community tap water, ad libitum
- Acclimation period: 4 days, under laboratory conditions after health examination. Only animals without any visual signs of illness were used for the study.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23
- Humidity (%): 30-70
- Air changes (per hr): approximately 10-15
- Photoperiod (hrs dark / hrs light): 12/12, automatically controlled light cycle. Music was played during the daytime light period.

IN-LIFE DATES: From: 2007-03-19 To: 2007-03-22

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): test matreial was applied undiluted
Duration of treatment / exposure:
4 hours
Observation period:
The skin reaction was assessed at approximately 1, 24, 48 and 72 hours after exposure (removal of the dressing, gauze patch and test substance).
Number of animals:
3 (1 ale and 2 females)
Details on study design:
TEST SITE
- Four days before treatment, the left flank was clipped with an electric clipper, exposing an area of approximately 100 cm2 (10 cm x 10 cm). The skin of the animals was examined one day before treatment, and regrown fur of all animals was clipped again. Animals with overt signs of skin injury or marked irritation which may have interfered with the interpretation of the results were not used in the test.
- Area of exposure: left flank (ca. 2.5 cm x 2.5 cm)
- % coverage: no data
- Type of wrap if used: the test item was placed on a surgical gauze patch. This gauze patch was applied to the intact skin of the clipped area. The patch was covered with a semi-occlusive dressing. The dressing was wrapped around the abdomen and anchored with tape.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The dressing was removed and the skin was flushed with lukewarm tap water.
- Time after start of exposure: 4 hours

OBSERVATION TIME POINTS
- Viability/Mortality: daily from acclimatization of the animals to the termination of test.
- Clinical signs: daily from acclimatization of the animals to the termination of test.
- Body weights: at start of acclimatization, on the day of application and at termination of observation.
- Skin reactions: approximately 1, 24, 48 and 72 hours after exposure (removal of the dressing, gauze patch and test item)

SCORING SYSTEM:
- The skin reaction was assessed according to the numerical scoring system listed in the Commission Directive 2004/73/EC, April 29, 2004.

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
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
- The three animals showed very slight erythema at 1 hour which did not persist. The mean score was calculated across three scoring times (24, 48, and 72 hours) for erythema and edema grades, separately. The two mean scores were 0 for all animals. No abnormal findings were observed on the treated skin 24 hours after treatment.
Other effects:
VIABILITY/MORTALITY
- No clinical signs of systemic toxicity were observed in the animals during the study and no mortality occurred.

COLORATION
- No staining by the test item of the treated skin was observed.

CORROSION
- Neither alterations of the treated skin was obsrved nor were corrosive effects evident on the skin.

BODY WEIGHTS
-The body weights of all animals were considered to be within the normal range of variability.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Based upon the referred classification criteria (Commission Directive 2001/59/EC of August 2001), TIC876 (T002675) is considered to be “not irritating” to rabbit skin.