Registration Dossier

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:
1 (reliable without restriction)

Data source

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

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: crystalline
Details on test material:
Standards for comparison: Diethyl phthalate, Cyclamen aldehyde, Geraniol

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
10 New Zealand White rabbits, aged 9-12 weeks are used for each test. The whole dorsal surface is clipped 3-4 days before the test is due to start, and animals in the telogen phase of hair growth are selected.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
not specified
Controls:
yes
Duration of treatment / exposure:
The test material and appropriate standards are applied to the clipped dorsum of rabbits for 4 hours under individual semi-occlusive patches,
the treated areas are wiped and examined for evidence of irritation.
Observation period:
72h
Number of animals:
8

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24h, 48h, 72h
Score:
0
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24h, 48h, 72h
Score:
0.33
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 24h, 48h, 72h
Score:
0
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
other: 24h, 48h, 72h
Score:
0
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
other: 24h, 48h, 72h
Score:
0
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
other: 24h, 48h, 72h
Score:
1.33
Irritation parameter:
erythema score
Basis:
animal: #7
Time point:
other: 24h, 48h, 72h
Score:
4
Irritation parameter:
erythema score
Basis:
animal: #8
Time point:
other: 24h, 48h, 72h
Score:
0.33
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 24h, 48h, 72h
Score:
0
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 24h, 48h, 72h
Score:
0.33
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 24h, 48h, 72h
Score:
0
Irritation parameter:
edema score
Basis:
animal #4
Time point:
other: 24h, 48h, 72h
Score:
0
Irritation parameter:
edema score
Basis:
animal #5
Time point:
other: 24h, 48h, 72h
Score:
0
Irritation parameter:
edema score
Basis:
animal #6
Time point:
other: 24h, 48h, 72h
Score:
0.67
Irritation parameter:
edema score
Basis:
animal: #7
Time point:
other: 24h, 48h, 72h
Score:
3.67
Irritation parameter:
edema score
Basis:
animal: #8
Time point:
other: 24h, 48h, 72h
Score:
0

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Only one animal shows mean value of ≥ 2,3 - ≤ 4,0 for erythema/eschar or for oedema in at least 2 of 3 tested animals from gradings at 24, 48 and 72 hours after patch removal. Therefore, it's not classified as irritating.