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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:
25. Oct 1956 - 19. Nov 1956
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1961
Report Date:
1961

Materials and methods

Principles of method if other than guideline:
BASF-Test:
Two animals were treated for 1, 5 or 15 min using occlusive conditions. An application site of 2.5x2.5 cm was covered with the liquid test substance. The animals were observed for 3 weeks and skin changes were recorded daily. For a final evaluation, the findings from 24 and 48 hours from the raw data were taken into account.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2.6 kg (mean)

Test system

Type of coverage:
occlusive
Preparation of test site:
not specified
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated skin of the same animal served as control
Duration of treatment / exposure:
1, 5 and 15 min
Observation period:
3 weeks
Number of animals:
2
Details on study design:
TEST SITE
- Area of exposure: 2.5x2.5 cm

REMOVAL OF TEST SUBSTANCE
- Washing (if done): conc. Lutrol and 50 % Lutrol solution
- Time after start of exposure: 1, 5 or 15 min post exposure

Results and discussion

In vivo

Results
Irritation parameter:
erythema score
Remarks:
15 min exposure
Basis:
mean
Time point:
other: 24 h - 48 h (72 h reading missing)
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 3 weeks
Remarks on result:
other: After 15 min exposure single haemorrhages occurred. After 8 days bean-sized crusts were seen. At the end of the observation period (3 weeks) increased hair growth was noted.

Any other information on results incl. tables

Mean erythema score after 24 and 48 (animal1/animal 2). 72 h reading is missing.

 Exposure time  same day  24 h  48 h  72 h  8 days  3 weeks
 1 min  1/0 1/0  1/1 -/-  0/0  0/0
 5 min  1/1 2/0 2/2  -/-  0/0 0/0 
 15 min  3/2 2/2 2/2 -/-  0/0  0/0

The original BASF grading was converted into the numerical grading according the OECD Draize system.

After 15 min exposure single haemorrhages occurred. After 8 days bean-sized crusts. At the end of the observation period (3 weeks) increased hair growth was noted.

Applicant's summary and conclusion

Interpretation of results:
Category 1B (corrosive) based on GHS criteria