Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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:
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
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Coumarin
EC Number:
202-086-7
EC Name:
Coumarin
Cas Number:
91-64-5
Molecular formula:
C9H6O2
IUPAC Name:
2H-chromen-2-one
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 or test system 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.