Registration Dossier

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: limited documentation, substance tested only as 50% dilution, Observation/reading only at 24 hours and 8 days, only 2 animals tested

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1967
Report Date:
1967

Materials and methods

Principles of method if other than guideline:
The test substance was applied substance as 50% dilution for 20 hours under occlusive conditions. Observation/reading only at 24 hours and 8 days, only 2 animals tested
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
purity ca. 90-96% (0-3% urea, 2% potassium sulfate)

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: ca. 2.8 kg
- sex: male

no further data

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
not specified
Amount / concentration applied:
Substance applied as a 50 % aqueous preparation (ca . 0.5 g on an area of about 2 .5 cm x 2.5 cm); occlusive application
Duration of treatment / exposure:
20 hours
Observation period:
8 days
Number of animals:
2
Details on study design:
TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24/48/72 hours
Score:
0
Remarks on result:
other: no signs of irritation were observed
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24/48/72 hours
Score:
0
Remarks on result:
other: no signs of irritation were observed

Any other information on results incl. tables

- Systemic toxicity: No mortality occurred. There were no   signs of clinical toxicity from the dermal exposure.

- Irritation score: No skin findings were observed at any time 

- Summary: Occlusive application for 20 hrs to rabbit   skin did not lead to any signs of irritation.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Occlusive application for 20 hrs to rabbit skin did not lead to any signs of irritation at any time during the 8 days of observation.