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Diss Factsheets

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
Study period:
August 13th, 1979 to September 2th 1979
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

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:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
4-methylanisole
EC Number:
203-253-7
EC Name:
4-methylanisole
Cas Number:
104-93-8
Molecular formula:
C8H10O
IUPAC Name:
1-methoxy-4-methylbenzene
Details on test material:
- Name of test material (as cited in study report): p-Methylanisole
- Analytical purity: no data given
Specific details on test material used for the study:
Name (as stated in the report): P-Cresyl Methyl Ether
Test concentrations: as supplied (undiluted)
Sample No. 11.336.T11
Apparence: Clear liquid

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
8 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:
unchanged (no vehicle)
Controls:
yes
Amount / concentration applied:
0.5 ml
Duration of treatment / exposure:
4 hours
Observation period:
24, 48 , 72 hours
Number of animals:
8
Details on study design:
Study design:
0.5 ml of the test material and appropriate standards were applied to the clipped dorsum of New Zealand White rabbits for 4 hours under individual semi-occlusive patches. After removal of the patches, the treated areas were wiped and examined for evidence of irritation. The position of the treatment sites were randomized. Skin sites were assessed for skin irritation immediately after treatment, 24, 48 and 72 hours.

Each animal was scored blind and the scores linked to the product after the 72 hours evaluation had been completed. Sites were scored for erythema, edema, cracking and scaling and any other feature using an 8-point achored ordinate scale ranging from "a" (very slight) to "h" (severe). Reaction grades are converted into a numerical score used to calculate the total irritation score per site, and a mean irritation score per site per day.


Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: 1242, 1243, 1240, 1241, 1238, 1209, 1211
Time point:
24 h
Score:
3
Irritation parameter:
erythema score
Basis:
animal: 1236
Time point:
24 h
Score:
4
Irritation parameter:
edema score
Basis:
animal: 1242, 1240, 1241, 1238,1211
Time point:
24 h
Score:
4
Irritation parameter:
edema score
Basis:
animal: 1243
Time point:
24 h
Score:
3
Irritation parameter:
edema score
Basis:
animal: 1236
Time point:
24 h
Score:
8
Irritation parameter:
edema score
Basis:
animal: 1209
Time point:
24 h
Score:
6
Irritation parameter:
erythema score
Basis:
animal: 1242, 1240, 1241, 1236, 1238, 1211
Time point:
48 h
Score:
4
Irritation parameter:
erythema score
Basis:
animal: 1243, 1209
Time point:
48 h
Score:
3
Irritation parameter:
edema score
Basis:
animal: 1242, 1243, 1211
Time point:
48 h
Score:
3
Irritation parameter:
edema score
Basis:
animal: 1240, 1209
Time point:
48 h
Score:
6
Irritation parameter:
edema score
Basis:
animal: 1236
Time point:
48 h
Score:
8
Irritation parameter:
erythema score
Basis:
animal: 1242, 1236, 1209
Time point:
72 h
Score:
4
Irritation parameter:
erythema score
Basis:
animal: 1243, 1241, 1211
Time point:
72 h
Score:
3
Irritation parameter:
erythema score
Basis:
animal: 1240, 1238
Time point:
72 h
Score:
6
Irritation parameter:
edema score
Basis:
animal: 1242
Time point:
72 h
Score:
4
Irritation parameter:
edema score
Basis:
animal: 1243, 1241
Time point:
72 h
Score:
3
Irritation parameter:
edema score
Basis:
animal: 1240, 1236, 1238, 1209
Time point:
72 h
Score:
6
Irritation parameter:
edema score
Basis:
animal: 1211
Time point:
72 h
Score:
8
Irritant / corrosive response data:
A single application of P - Cresyl methyl ether produced generally fairly distinct erythema and d'istinct oedema, two animals showed fairly well developed to well developed oedema at 24 hr. By 48 hr and 72 hr there was generally fairly distinct to fairly well developed erythema and oedema; one animal had a pale brown area over 1/3 of the treatment site. The level of response was greater than that produced by the control, Diethyl Phthalate, and broadly similar to that produecd by the controls, Cyclamen aldehyde and Geraniol.

Any other information on results incl. tables

Under the conditions of this test P-cresyl methyl ether is moderately irrritant to rabbit skin. This level of response is greater than that produced by Cyclamen aldehyde and Geraniol.

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritant) based on GHS criteria
Conclusions:
According to the authors the test material at 100% was moderately irritating to rabbit skin under the experimental conditions chosen.
Executive summary:

New Zealand White rabbits were assessed for dermal irritation following a 4 hour exposure under semi-occlusive conditions. Application sites were scored for immediately after exposure, 24, 48 and 72 hours later. The results showed fairly distinct erythema and edema at 24 hrs and by 48 and 72 hrs these reactions were between fairly distinct and fairly well developed. Under the conditions of this test, the test material was considered a moderate irritant to rabbit skin.