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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:
5 Jul.- 9 Jul 1993
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: A well performed study according to OECD Guideline 404 (valid in 1993).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993
Report Date:
1993

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: OECD Guideline 404 and Annex V to 92/69/EEC of 31/7 92 part B.4.
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
other: SPF Albino female rabbits of the stock MOL: Russian
Strain:
other: SPF Albino female rabbits of the stock MOL: Russian
Details on test animals and environmental conditions:
TEST ANIMALS
- Source:Möllegard Breeding Centre Ltd, Ejby, DK4623 Lille Skensved
- Age at study initiation: Not specified
- Weight at study initiation:2.4-2.6 kg
- Fasting period before study: Not specified.
- Housing: Cages PPL 45x44 cm perforated floor, single in each cage
- Diet (e.g. ad libitum): ad libitum diet, Altroim 2123
- Water (e.g. ad libitum): Water acidified with HCl to pH 2.5
- Acclimation period: Minimum one week.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 3 °C
- Humidity: 55 ± 15 %
- Air changes (per hr):10 times/day
- Photoperiod (hrs dark / hrs light):12 hrs light/12 hrs dark

IN-LIFE DATES: From:day 1 To: day 14

Test system

Type of coverage:
occlusive
Vehicle:
other: 0.5 g Sesam Oil
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 5000 mg
- Concentration (if solution): 0.5 g of test substance and 0.5 g of veichle (sesam oil)

VEHICLE
- Amount(s) applied (volume or weight with unit): 0.5 g of test substance and 0.5 g of veichle (sesam oil)
Duration of treatment / exposure:
4 h
Observation period:
1 hour after exposure
Number of animals:
4
Details on study design:
TEST SITE
- Area of exposure:2.2x2.5 cm (back of the rabbit)
- % coverage: 100 % (not explicit specified, tape round the patch)
- Type of wrap if used: The gauze patches with test substance were fixed with Scanpor tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done):Soap and lukewarm water
- Time after start of exposure: 4 hrs

SCORING SYSTEM:
0 No erythema
1 Very slight erythema
2 Well defiend erthema
3 Moderate to severe erythema.
4 Severe erythema, deep injuries
.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Score:
0.1
Max. score:
1
Remarks on result:
other: Max. duration: 24 d; Max. value at end of observation period: 0
Irritation parameter:
edema score
Basis:
mean
Score:
0
Max. score:
0
Remarks on result:
other: Max. duration: 0 d; Max. value at end of observation period: 0
Irritant / corrosive response data:
Reversibility of any observed effect: Changes fully reversible within 1 days
Other effects:
At the 24 hour reading very slight erythema was observed on the skin of one rabbit.

Applicant's summary and conclusion

Interpretation of results:
other: not classified
Conclusions:
The conclusion of the registrant is that Gelpaste Urea is not a skin irritant.