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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:
From May. 14, 1979 to Jun. 5, 1979
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report Date:
1979

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EPA OPP 81-5 (Acute Dermal Irritation)
Deviations:
not specified
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
-non-GLP study with non-OECD 404 testing protocol: 24h occlusive wrapping
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Physical state: Liquid

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: IVANOVAS, 7964 Kisslegg/Allgäu, Germany and MADOERIN AG, 4414 Füllinsdorf, Switzerland
- Age at study initiation: Not reported
- Weight at study initiation: 2 to 3 kg
- Housing: Housed individually in metal cages
- Diet: Standard rabbit food, NAFAG, No. 814, Gossau SG, ad libitum
- Water: ad libitum
- Acclimation period: Minimum of 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 55 ± 10
- Air changes (per hr): Not reported
- Photoperiod (hrs dark / hrs light): 14 hrs dark/10 hrs light

Test system

Type of coverage:
occlusive
Preparation of test site:
other: shaved with or without abrasion
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
Duration of treatment / exposure:
Single exposure for 24 hours
Observation period:
7 days
Number of animals:
3 males and 3 females
Details on study design:
TEST SITE
- Area of exposure: abraded and intact skin (back and flank)
- % coverage: 2.5 x 2.5 cm
- Type of wrap if used: Gauze patches (with the test material) were covered with an impermeable material and were fastened to the body of the rabbit with adhesive tape.
the shaven skin on one side was slightly scarified with the help of a "Schropfschnapper", Aesculap, Switzerland.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): not reported
- Time after start of exposure: Dressings were removed 24 hours after application.

SCORING SYSTEM: Same as the scale provided in the OECD guideline.
Calculation of the primary skin irritation index: The scores read after 24 and 72 hours for erythema and edema for the intact as well as for the abraded skin were summed up and divided by 4.

Assessment of Irritation:
0 = none
>0 – 1 = minimal
>1 – 2 = slight
>2 – 4 = moderate
>4 – 6 = marked
>6 – 8 = extreme

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Remarks:
intact skin
Basis:
mean
Time point:
24/48/72 h
Score:
0.44
Max. score:
1
Reversibility:
fully reversible within: 3 days
Irritation parameter:
edema score
Remarks:
intact skin
Basis:
mean
Time point:
24/48/72 h
Score:
0.05
Max. score:
1
Reversibility:
fully reversible within: 3 days
Irritation parameter:
erythema score
Remarks:
abraded skin
Basis:
mean
Time point:
24/48/72 h
Score:
0.44
Max. score:
1
Reversibility:
fully reversible within: 3 days
Irritation parameter:
edema score
Remarks:
abraded skin
Basis:
mean
Time point:
24/48/72 h
Score:
0.11
Max. score:
1
Reversibility:
fully reversible within: 3 days
Irritant / corrosive response data:
The calculated primary irritation index was 0.47. Test substance was found to cause a minimal irritation when applied to intact and abraded rabbit skin. The mean group score for erythema was 0.66, 0.66 and 0 for intact skin after 24, 48 and 72 hours, respectively. The mean group score for edema was 0.17, 0 and 0 for intact skin after 24, 48 and 72 hours, respectively.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test item was found to be not irritant to the skin under the test conditions applied.