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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
other: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
From December 17 to January 9, 1980
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
The test was conducted by means of Read Across approach. The reliability of the source study report is 2. Further information was attached at section 13

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report Date:
1980

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EPA OPP 81-5 (Acute Dermal Irritation)
Deviations:
no
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: IVANOVAS
- Age at study initiation: 2-3 kg
- Weight at study initiation:
- Housing: metal cage
- Diet: standard rabbit food - NAFAG ad libitum
- Water: ad libitum
- Acclimation period: 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2 °C
- Humidity (%): 55 ± 10 %
- Photoperiod : 10 hours light cycle dark/light

Test system

Type of coverage:
occlusive
Preparation of test site:
other: shaved and scarified
Vehicle:
other: propylene glycol + saline (70 : 30 parts)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.5 g of the test material
- Concentration: 50 %

Duration of treatment / exposure:
24 hour
Observation period:
7 days
Number of animals:
3 male and 3 female
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used:The patches were covered with an impermeable material and were fastened to the body of the rabbit with adhesive tape.



Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: 164, 169
Time point:
24/48/72 h
Score:
ca. 0.33
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal: 165, 166, 167, 168
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
0
Reversibility:
other: No signs of irritation
Irritation parameter:
edema score
Basis:
animal: 164, 169
Time point:
24/48/72 h
Score:
ca. 0.33
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal: 165, 166, 167, 168
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
0
Reversibility:
other: No signs of irritation

Any other information on results incl. tables

Due to intensive staining by the test compound erythema was not assessable. For the purpose of calculating the primary irritation index erythema was assumed to be equal to edema based on the correlation existing (Marzulli and Maibach, Fol. Cosm. Tox. 13, 355, 1975).

Evaluation of the skin reactions

TIME After 24 h After 49 h After 72 h
SEX MALE FEMALE MALE FEMALE MALE FEMALE
Animal N° 164 165 166 167 168 169 164 165 166 167 168 169 164 165 166 167 168 169
Erythema a 1 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0
b 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Edema a 1 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0
b 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Total a 2 0 0 0 0 2 0 0 0 0 0 0 0 0 0 0 0 0
b 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Mean a 0.6 0.6 0 0 0 0
b 0 0 0 0 0 0
Group mean a 0.6 0 0
b 0 0 0
TIME After 4 days After 7 days
SEX MALE FEMALE MALE FEMALE
Animal N° 164 165 166 167 168 169 164 165 166 167 168 169
Erythema a 0 0 0 0 0 0 0 0 0 0 0 0
b 0 0 0 0 0 0 0 0 0 0 0 0
Edema a 0 0 0 0 0 0 0 0 0 0 0 0
b 0 0 0 0 0 0 0 0 0 0 0 0
Total a 0 0 0 0 0 0 0 0 0 0 0 0
b 0 0 0 0 0 0 0 0 0 0 0 0
Mean a 0 0 0 0
b 0 0 0 0
Group mean a 0 0
b 0 0

mean reaction score
time after exposure erythema edema
intact
skin
abraded
skin
intact
skin
abraded
skin
24 0.3 0 0.3 0
72 0 0 0 0
total 0.3 0 0.3 0 0.6

Applicant's summary and conclusion

Interpretation of results:
other: CLP criteria not met
Conclusions:
Non irritant
Executive summary:

The substance has been tested According to EPA OPP 81 -5 guideline. Under the conditions of the present experiment the test item was found to cause no irritation when applied to intact and abraded rabbit skin according to the Regulation EC n. 1272/2008.