Registration Dossier

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:
2 (reliable with restrictions)

Data source

Reference
Title:
Unnamed
Year:
2008

Materials and methods

Test guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
2-methylresorcinol
EC Number:
210-155-8
EC Name:
2-methylresorcinol
Cas Number:
608-25-3
Molecular formula:
C7H8O2
IUPAC Name:
2-methylbenzene-1,3-diol

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
other: moistened
Amount / concentration applied:
0.5 gram
Duration of treatment / exposure:
4 h
Observation period:
1, 24, 48, 72 h
Number of animals:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Reversibility:
fully reversible
Remarks on result:
other: application of the undiluted test substance resulted in very slight erythema in the treated skin-area of one out of the three treated rabbits one hour after instillation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Reversibility:
fully reversible

Any other information on results incl. tables

Guideline: OECD 404

Species: New Zealand White rabbits

Group: 3 males

Test substance: 2 -methylresorcinol

Purity: 98.6%

Dose: 0.5g

GLP: in compliance

An aliquot of 0.5 g of the moistened test substance was exposed to the intact shaved back

skin of each animal for 4 hours under semi-occlusive conditions. Animals were examined

approximately 1 hour, 24, 48 and 72 hours after termination of the exposure.

Results

The test substance caused orange staining of the skin but the investigators said that this did

not affect observations.

Under the conditions of the study, application of the undiluted test substance resulted in

very slight erythema in the treated skin-area of one rabbit one hour after instillation.

Conclusion

The test substance applied undiluted to rabbit skin showed mild and transient skin irritation.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU