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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
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

Constituent 1
Chemical structure
Reference substance name:
Dicyclohexylamine
EC Number:
202-980-7
EC Name:
Dicyclohexylamine
Cas Number:
101-83-7
Molecular formula:
C12H23N
IUPAC Name:
N-cyclohexylcyclohexanamine
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
Time point:
24 h
Score:
ca. 4
Max. score:
4
Reversibility:
not specified
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
>= 1 - <= 2
Max. score:
4
Reversibility:
not specified
Irritation parameter:
edema score
Basis:
animal #1
Time point:
7 d
Score:
ca. 1
Max. score:
4
Reversibility:
not specified
Irritation parameter:
other: necrosis
Basis:
animal #1
Time point:
7 d
Reversibility:
not specified
Remarks on result:
other: from d7 necrosis was observed in 2/2 rabbits
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48 h
Score:
ca. 4
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: different set of time points
Remarks:
24h and 48H were the only tie points used in this study
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
>= 1 - <= 2
Max. score:
4
Reversibility:
not specified
Irritation parameter:
edema score
Basis:
animal #2
Time point:
7 d
Score:
ca. 1
Max. score:
4
Reversibility:
not specified
Irritation parameter:
other: necrosis
Basis:
animal #2
Time point:
7 d
Reversibility:
not specified
Remarks on result:
other: from d7 necrosis was observed in 2/2 rabbits
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
48 h
Score:
4
Max. score:
4
Reversibility:
not specified
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
72 h
Score:
4
Max. score:
4
Reversibility:
not specified

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