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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:
06-Nov-1996 to 14-Nov-1996
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study (OECD test guideline 404)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report Date:
1997

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
adopted on 17-Jul-1992
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Description: off white solid
- Analytical purity: 99.35-99.45 %
- Storage: at room temperature, away from light

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Dr. Karl Thomae GmbH, Birkendorferstrasse 65, 88397 Biberach/Riss, Germany
- Age at study initiation: 15 weeks
- Weight at study initiation: 3.0 kg (male), 3.0-3.1 kg (females)
- Housing: individually, in stainless steel cages
- Diet: pelleted standard rabbit maintenance diet (Kliba 341, Kliba Mühlen AG, 4303 Kaiseraugst, Switzerland), ad libitum
- Water: tap water, ad libitum
- Acclimation period: 4 days

ENVIRONMENTAL CONDITIONS
- Temperature: 20 ± 3 °C
- Humidity: 40-70 %
- Air changes: 10-15 changes/hour
- Photoperiod: 12 hours dark / 12 hours light

IN-LIFE DATES: 06-Nov-1996 to 14-Nov-1996

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
other: moistened with bi-distilled water
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.5 g
Duration of treatment / exposure:
4 hours
Observation period:
at least 72 hours
Number of animals:
1 male, 2 female rabbits
Details on study design:
TEST SITE
- Area of exposure: dorsal
- Area of exposure: 6 cm²
- Type of wrap if used: surgical gauze patch with semi-occlusive dressing

REMOVAL OF TEST SUBSTANCE
- Washing: with lukewarm tap water
- Time after start of exposure: 4 hours

SCORING SYSTEM:
The skin reaction was assessed according to the numerical scoring system listed in Directive 93/21/EEC (according to Draize, 1959) at approximately 1, 24, 48 and 72 hour(s) after the removal of the dressing, gauze patch and test item.
Minimal score: 0, maximal score: 4 (erythema and eschar formation, oedema formation)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
(male)
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
4
Remarks on result:
other: individual mean score
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
(female)
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
4
Remarks on result:
other: individual mean score
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
(female)
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
4
Remarks on result:
other: individual mean score
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
(male)
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
4
Remarks on result:
other: individual mean score
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
(female)
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
4
Remarks on result:
other: individual mean score
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
(female)
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
4
Remarks on result:
other: individual mean score
Irritation parameter:
overall irritation score
Basis:
animal: #1, #2, #3
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
8
Remarks on result:
other: calculated value
Irritant / corrosive response data:
The test item showed no irritant or corrosive potential.
Other effects:
No clinical signs of systemic toxicity were observed during the test and observation period, and no mortality occurred. No staining of the treated skin by the test item was observed. The body weight gain of all rabbits was within the normal range of variability.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Based on the results of this study, the test article is regarded as not irritating to the rabbit skin.
Executive summary:

The primary skin irritation potential of the test article was investigated by semiocclusive, topical application of 0.5 g onto 6 cm2 intact dorsal skin of each of three young adult New Zealand rabbits. After 4 hours, the test item was removed with lukewarm water. The scoring of skin reactions was performed 1, 24, 48 and 72 hours after removal of the dressing. The scores of each animal at the following reading times (24, 48, 72 hours) were used in calculating the respective mean values for each type of lesion. The primary irritation score was calculated by totaling the individual cumulative scores at 24, 48 and 72 hours and then dividing by the number of figures. Under the conditions of this experiment, the test substance was found to cause a primary irritation score of 0.00 (max. 8.0) when applied to healthy intact rabbit skin. Local signs (mean values from 24 to 72 hours) consisted of grade 0.00 erythema and grade 0.00 edema. No clinical signs of systemic toxicity were observed during the test and observation period, and no mortality occurred. No staining of the treated skin by the test item was observed. The body weight gain of all rabbits was within the normal range of variability. No corrosive effects were noted on the treated skin of any animal at any measuring interval. Based on the results of this study, the test article is regarded as not irritating to the rabbit skin.