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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:
weight of evidence
Study period:
1992-01-14 to 1992-02-07
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report Date:
1992

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
1981
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Version / remarks:
1984
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: Liquid: Clear colourless
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: T 16/91
- Expiration date of the lot/batch: July 1992
- Purity test date: 1992-05-13

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: in the dark
- Stability under test conditions: stable

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: HOECHST AG, Kastengrund
- Age at study initiation: about 3-5 months
- Weight at study initiation: 2700-3600 g
- Housing: single
- Diet: Altromin 2123 Haltungsdiat - Kaninchen, Altromin-GmbH (Lage/Lippe, Germany), ad libitum
- Water: deionized, chlorinated water ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18+/- 3
- Humidity (%): 55+/- 20
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
physiological saline
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 500 mg
- Concentration: ca. 90 %

VEHICLE
- Amount applied: 0,05 mL NaCl (0,9 %)
Duration of treatment / exposure:
3 minutes and 4 hours
Observation period:
Observations were caried out 30-60 min and 24, 48, 72 h, 7 days and 14 days after removal of the test substance.
Number of animals:
3 animals (3 min exposure)
1 animal (4 hours exposure)
Details on study design:
TEST SITE
- Area of exposure: dorsal, about 2.5 x 2.5 cm
- Type of wrap if used: semiocclusive

REMOVAL OF TEST SUBSTANCE
- Washing: rinsing with tap water
- Time after start of exposure: 3 min or 4 h


OBSERVATION TIME POINTS
30-60min, 24 h, 48 h, 72 h, 7 days, 14 days

SCORING SYSTEM:
Erythema and edema were scored according to a 5 graded scale.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Remarks:
4 hours exposure
Basis:
animal #1
Remarks:
only one animal tested
Time point:
24/48/72 h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within:
Remarks:
14 days
Remarks on result:
positive indication of irritation
Irritation parameter:
edema score
Remarks:
4 hours exposure
Basis:
animal #1
Remarks:
only one animal tested
Time point:
24/48/72 h
Score:
1.3
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Remarks on result:
positive indication of irritation
Irritation parameter:
erythema score
Remarks:
3 minutes exposure
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Remarks:
3 minutes exposure
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Remarks:
3 minutes exposure
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Remarks:
3 minutes exposure
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Remarks:
3 minutes exposure
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Remarks:
3 minutes exposure
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
No signs of skin irritation were noticed after an exposure period of 3 minutes.
The animal exposed for 4 hours exhibited moderate to severe erythema at the observation time points 30-60 min, 24, 48, 72 h (score 3, respectively). At the observation time points 7 and 14 days the erythema were scored 4 (severe). Therefore, the findings were considered not reversible.
Edema were scored 3, 2, 1 and 1 at the time points 30-60 min, 24 h, 48 h and 72 hours and 1 after 7 and 14 days.
Other effects:
- Other adverse local effects: The skin appeared discoloured/white after 4 hours exposure. Further effects observed throughout the observation period: encrustation, scaled and dry skin.

Applicant's summary and conclusion

Interpretation of results:
Category 1C (corrosive) based on GHS criteria
Conclusions:
The test material was shown to be corrosive to skin after an exposure period of 4 hours.
Executive summary:

The test material was examined for its potential to cause skin irritation/corrosion in New Zealand White rabbits. 500 mg were diluted with 0.05 mL 0.9 % NaCl and applied under semiocclusive dressing. Three animals were exposed for 3 minutes, one animal was exposed for 4 hours. After removal of the patches the test sites were washed with tap water. Skin findings were scored 30-60 min, 24 h, 48 h, 72 h and 7 and 14 days after removal. No skin findings were noted in the animals exposed for 3 minutes. Signs of moderate to severe irritation were observed in the animal exposed for 4 hours. These findings were not reversible within the 14 days-observation period. Therefore the test item was concluded to be corrosive to skin.