Registration Dossier

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:
1988-01-19 to 1988-03-07
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study. No GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report Date:
1988

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
May 12, 1981
Deviations:
no
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: colourless liquid

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Gaukler; D-6050 Offenbach/Main; Germany
- Weight at study initiation: Male: 2.90 kg; Females: 3.05 kg;
- Housing: single animals in stainless steel cages with wire mesh walk floors; floor area: 40 x 51 cm
- Diet: Kliba 341, 4 mm; Klingentalmühle AG, CH-4303 Kaiseraugst, Switzerland; abt. 130 g per animal per day
- Water: abt. 250 mL tap water per animal per day
- Acclimation period: at least 8 days before beginning of the study; same housing conditions as during the study

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 -24
- Humidity (%):30 -70
- Photoperiod (hrs dark / hrs light): !2 h/12 h (6.00 - 18 .00 hours/18 .00 - 6 .00 hours)

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
undiluted;
Amount applied: 0.5 mL
Duration of treatment / exposure:
4 hours
Observation period:
15 days
Number of animals:
3 (1 male, 2 females)
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: four layers of absorbent gauze and porous bandage

REMOVAL OF TEST SUBSTANCE
- Washing: with Lutrol and Lutrol/water 1:1
- Time after start of exposure: 4 h

SCORING SYSTEM:
Calculation of the mean according to 83/467/EEC criteria of July 29th, 1983; for calculation of the means of erythema and edema only the readings of 24, 48, and 72 hours are used
EVALUATION OF ERYTHEMA (R) AND EDEMA (ED) :
0 = NONE
1 = VERY SLIGHT
2 = WELL-DEFINED
3 = MODERATE TO SEVERE
4 = SEVERE TO VERY SEVERE

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
(0344)
Time point:
other: 24, 48, 72 h
Score:
2.7
Max. score:
4
Reversibility:
fully reversible within: 15 d
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
(0342)
Time point:
other: 24, 48, 72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 8 d
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
(0306)
Time point:
other: 24, 48, 72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 8 d
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
1.6
Max. score:
4
Reversibility:
fully reversible within: 15 d
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
(0344)
Time point:
other: 24, 48, 72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 8 d
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
(0342)
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
(0306)
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0.1
Max. score:
4
Reversibility:
fully reversible within: 8 d
Irritant / corrosive response data:
Not irritating
Other effects:
No data

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information