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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 analogue substance
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report Date:
1978

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Code of Federal Regulations, Title 16, Section 1500.41
Principles of method if other than guideline:
The hair was removed from the lateral skin over an area of about 8 x 8 cm on both sides of the trunks of 6 rabbits with an average weight of 2.3 kg using electric clippers 24 hours before the beginning of the study. The skin on the right flank was also abraded by means of a scarifier at the site where the test patch was to be applied. Patches (2.5 x 2.5 cm) of double layers of surgical gauze were coated/impregnated with 500 mg of the test substance made into a paste with water and covered with indifferent impermeable PVC film (5 x 5 cm). The film with the patch underneath was attached to the two test sites by means of adhesive tape (Leukoflex R ) that does not irritate the skin. The whole trunk of the animals was then bandaged with an elastic fixed bandage (Elastoflex R ) for the duration of the exposure period of 24 h. The animals were restrained.Findings were reported immediately (about 30 min) after the removal of the patches (24-h value) and then 48 h and 72 h after the beginning of the study (48 h after the first reading).
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
semi-solid (amorphous): gel
Remarks:
migrated information: paste

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS- Source: Versuchstierzuchten W. Ostrop, Meerbusch, F.R.G.- Housing: animals were housed in single cages.- Diet: "muemmel z" feed (sniff, Soest F.R.G.) ad libitum- Water: ad libitum- Acclimation period: 4-6 days.ENVIRONMENTAL CONDITIONS- Temperature (°C): 16-18 °C- Humidity (%): 40%

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
no
Amount / concentration applied:
TEST MATERIAL- Amount applied: 500 mg
Duration of treatment / exposure:
24 h
Observation period:
8 days
Number of animals:
6
Details on study design:
TEST SITE- Area of exposure: 2.5 x 2.5 cm- Type of wrap if used: Leukoflex, ElastoflexSCORING SYSTEM: Erythema and eschar formation: Value- No erythema: 0- Very slight erythema (barely perceptible): 1- Well-defined erythema: 2- Moderate to severe erythema: 3- Severe erythema (beet redness) to slight eschar formation (injuries in depth): 4Edema formation- No edema: 0- Very slight edema (barely perceptible): 1- Slight edema (edges of area weil defined by definite raising): 2- Moderate edema (raised approximately 1 mm): 3- Severe edema (raised more than 1 mm and extending beyond the area of exposure): 4

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: Reading and exact calculation of the erythema index not possible because of staining of the skin caused by the test substance. Staining persisted until study end (8 days).
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: The 48-h value does not appear on the report sheet.

Any other information on results incl. tables

Reading and exact calculation of the erythema index not possible because of staining of the skin caused by the test.

Mean edema score:

   Animal No.  24h  72h  8 days  mean 24 -72 h  mean score all animals (24 - 72 h)        
 intact skin  1  0  0  0  0          
   2  1  1  2  1          
   3  0  0  0  0          
   4  0  3  0  1.5          
   5  1  2  2  1.5          
   6  0  0  1          
             0.83        
 abraded skin  1  1  0  0  0.5          
   2  1  2  2  1.5          
   3 1  1  0  1          
   4  1  3  1  2          
   5  1  2  2  1.5          
   6  0  0  0          
             1.083        

Applicant's summary and conclusion

Interpretation of results:
other: Not classified under Regulation 1272/2008
Conclusions:
The analogue substance 1 was tested for skin irritation following Code of Federal Regulations, Title 16, Section 1500.41 . Under the experimental conditions the substance does not show any skin irritation potential.
Executive summary:

The analogue substance 1 was tested for skin irritation following Code of Federal Regulations, Title 16, Section 1500.41 . Under the experimental conditions the substance does not show any skin irritation potential.