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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:
13 January - 27 January, 1984
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
Limited information about substance identity and no GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984
Report Date:
1984

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
first version 1981.
Deviations:
yes
Remarks:
Occlusive instead of semi-occlusive, but not considered to have affected the reliability.
GLP compliance:
no
Remarks:
performed before GLP was in place in the EU.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Details on test material:
- Physical appearance: light yellow powder

Test animals

Species:
rabbit
Strain:
other: white Russian
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Asta-Werke AG, D-4800 Bielefeld 14, Germany
- Age at study initiation: 5 months
- Weight at study initiation: 2.2 - 2.4 kg (males and females)
- Housing: Single in stainless steel cages modell Asta
- Diet (e.g. ad libitum): standard rabbit diet (Altromin R)
- Water: Free access to tap water
- Acclimation period: 1 day

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 1
- Humidity (%): 50 - 60
- Air changes (per hr): No data available
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.5 g moistened with 0.15 mL Aqua dest
Duration of treatment / exposure:
4h
Observation period:
1, 24, 48 and 72 hours
Number of animals:
3
Details on study design:
STUDY DESIGN
The test substance was applied under a 6.25 cm2 patch to intact skin on each animal. The patches were covered by an overlapping patch of adhesive plastic. The whole area was then bound by occlusive tape (Acrylastic, Beiersdorf and Co.) wrapped round the entire trunk of the animal.

TEST SITE
The rabbits were prepared by shaving the skin of the back free of hair. The left and right site of the back were split up in four patch test areas and two areas were abraded.

SCORING SYSTEM:
The irritation scores were recorded.The irritation was assessed according to OECD 404.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritant / corrosive response data:
The test substance caused no erythema and no edema at any time point on the intact skin test sites.
Other effects:
No signs of systemic intoxication were observed during the study period.

Applicant's summary and conclusion

Interpretation of results:
other: Not classified according to Regulation (EC) 1272/2008
Conclusions:
In a skin irritation study with rabbits, performed equivalent or similar to OECD 404 guideline, no irritation was observed.
Executive summary:

In a skin irritation study performed according to OECD test guideline 404, the substance (0.5 g) was applied onto the shaved skin of three rabbits using occlusive dressings for 4 hours. Under the conditions of this study, no irritation was observed for 72 hours. The test substance caused no erythema and no edema on the intact skin test sites. No signs of systemic intoxication were observed during the study period.