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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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP Study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report date:
1999

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:
other: EU method B.4 (Acute Toxicity: Dermal Irritation/Corrosion
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
T-7145
IUPAC Name:
T-7145
Details on test material:
- Name of test material (as cited in study report: T-7145
- Physical state: Clear colorless liquid
- Analytical purity: Expected to be > 99.5%
- Lot/batch no.: Lot 4
- Expiration date of the lot/batch: April 28,2000

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
Sex: male
TEST ANIMALS
- Source: Charles River Deutschland
- Age at study initiation: at least 6 weeks
- Weight at study initiation: 1732, 1668, 1601 grams
- Housing:- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): approx 21 C
- Humidity (%): approx 50%
- Air changes (per hr): approx 15
- Photoperiod (hrs dark / hrs light): 12 hour dark/12 hour light

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
- Concentration (if solution): applied undiluted
Duration of treatment / exposure:
4 hours
Observation period:
1, 24, 48 and 72 hours
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 150 square centimeters
- Type of wrap if used: 2 x 3 cm patch
REMOVAL OF TEST SUBSTANCE
- Washing (if done): water
- Time after start of exposure: 4 hours after application
SCORING SYSTEM: 0 - 4 erythema and eschar formation; 0 - 4 edema formation

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Time point:
other: 4 hours
Score:
0
Irritant / corrosive response data:
No signs of skin irritation, corrosion, skin coloring or toxicity was observed .Scores of 0 were noted at all timepoints.

Any other information on results incl. tables

No signs of skin irritation, corrosion, skin coloring or toxicity was observed .Scores of 0 were noted at all timepoints.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
No skin irritation was observed at any time point in any of the animals. According to EC criteria in Guidelines in Commission Directive 93/21/EEC, the test material does not have to be classified and has no obligatory labelling requirement for skin irritation.
Executive summary:

Primary skin irritation study with the test material in the rabbit (4 hour semi-occlusive application) was conducted. Three rabbits were exposed to 0.5 ml of test material, applied onto clipped skin for 4 hours using a semi-occlusive dressing. Observations were made at 1, 24, 48 and 72 hours after exposure. No skin irritation was observed at any time point in any of the animals. According to EC criteria in Guidelines in Commission Directive 93/21/EEC, the test material does not have to be classified and has no obligatory labelling requirement for skin irritation.