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:
test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Data source

Reference
Reference Type:
other: other type of company data
Title:
Unnamed
Year:
1979
Report Date:
1979

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
2 rabbits (male and female), 500 μl per one ear of the rabbit fixed with a plaster, the other ear served as control, rinsing post exposure, reading 24h, 48h, and d2, 4, 5, 6, 7, post exposure observation time:7d
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
not specified
Details on test material:
DCHA undiluted, purity >99 % w/w

Test animals

Species:
rabbit
Strain:
not specified

Test system

Type of coverage:
semiocclusive
Preparation of test site:
not specified
Vehicle:
unchanged (no vehicle)
Controls:
other: unexposed ear used as a control
Amount / concentration applied:
500 ul/one ear
Duration of treatment / exposure:
24h
Observation period:
24,48h
2, 4, 5, 6, 7d
Number of animals:
2

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: 2/2
Time point:
other: 24-48h
Score:
4
Max. score:
4
Reversibility:
no data
Irritation parameter:
other: swelling
Basis:
animal: 2/2
Time point:
other: 2d
Score:
1 - 2
Max. score:
4
Reversibility:
no data
Irritation parameter:
other: swelling
Basis:
animal: 2/2
Time point:
other: 7d
Score:
1
Max. score:
4
Reversibility:
no data
Irritation parameter:
other: necrosis
Basis:
animal: 2/2
Time point:
other: 7d
Reversibility:
no data
Remarks on result:
other: from d7 necrosis was observed in 2/2 rabbits

Any other information on results incl. tables

from 24 or 48 hours post exposure: erythema (score: 4/max.4 in 2/2 rabbits)
from the second day post exposure: slight swelling (score: 2/max.4 and score: 1/max.4) which diminished within 7 days (score: 1/max.4 in both rabbits)
from d 7: necrosis was observed in 2/2 rabbits

Applicant's summary and conclusion

Interpretation of results:
corrosive
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Test substance showed corrosive effects on skin of animals.
Executive summary:

2 rabbits (male and female) were used, 500 μl of DCHA/one ear of the rabbit with semiocclusive coverage used, the other ear

served as control, necrosis found on day 7 of follow/up