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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:
2001/02/26 - 2001/05/08
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study (OECD 404)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2003
Report Date:
2003

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:
not specified
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): ETU
- Characteristics: light beige powder
- Assay (purity) = 99.6%
- Lot/batch No.: L33-99
- Storage condition of test material: at room temperature or colder

Test animals

Species:
rabbit
Strain:
Himalayan
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: LPT Laboratory of Pharmacology and toxicology kg
- Age at study initiation: 5-6 months
- Weight at study initiation: 2.2-2.5 kg
- Housing: singly in special restrainers with dimensions of 425 mm x 6000 mm x 380 mm which allowed free movement of the head but prevented a complete body turn.
- Diet (e.g. ad libitum): altromin 2023, available before and after the exposure period.
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: At least 20 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3°C
- Humidity (%): 55+/-15%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: To:

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
no
Amount / concentration applied:
500 mg ETU per patch per animal, once epicutaneous
Duration of treatment / exposure:
4 hours
Observation period:
60 minutes, 24-48-72 hours
Number of animals:
3 rabbits (males)
Details on study design:
TEST SITE
- Area of exposure: dermal application to the shaved intact dorsal skin
- % coverage: 6 cm²
- Type of wrap if used: a gauze patch

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
- Time after start of exposure: 4 hours

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
3 rabbits
Time point:
other: 24-48-72 hours
Score:
0
Max. score:
4
Remarks on result:
other: No effect on skin were observed.
Irritation parameter:
edema score
Basis:
mean
Remarks:
3 rabbits
Time point:
other: 24-48-72 hours
Score:
0
Max. score:
4
Remarks on result:
other: No effect on skin were observed
Irritant / corrosive response data:
Any reaction was observed: erythema score and edema score were equal to 0 at all time.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: Regulation EC no.1272/2008 (CLP)
Conclusions:
Under the present test conditions none of the three rabbits exposed for 4 hours to 500 mg ETU per patch and animal showed any substance-related lesions at the examination time-points 60 min and 24, 48 and 72 hours after patch removal. There were no systemic intolerance reactions.
ETU was non-irritating to skin, hence, no labelling is required.
Executive summary:

The aim of this examination was to examine ETU for acute skin irritation in rabbits (patch test). After the 4 -hour exposure period, the patch was removed and the skin sites of the three animals were evaluated.

Under the present test conditions none of the three rabbits exposed for 4 hours to 500 mg ETU per patch and animal showed any substance-related lesions at the examination time-points 60 min, and 24, 48 and 72 hours after patch removal. There were no systemic intolerance reactions.