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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From Mar. 1, 1988 to Mar. 25, 1988
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Well documented, according to accepted guideline, with GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report date:
1988

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
3-(3-tert-butyl-4-hydroxyphenyl)propionic acid
EC Number:
403-920-4
EC Name:
3-(3-tert-butyl-4-hydroxyphenyl)propionic acid
Cas Number:
107551-67-7
Molecular formula:
C13H18O3
IUPAC Name:
3-(3-tert-butyl-4-hydroxyphenyl)propanoic acid

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, CH-4414 Fuellinsdorf.
- Age at study initiation: Approximately 12-14 weeks old.
- Weight at study initiation: Between 2570 to 2630 g.
- Housing: The animals were housed individually in metal cages.
- Diet (e.g. ad libitum): ad libitum.
- Water (e.g. ad libitum): ad libitum.
- Acclimation period: 5 days.


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±3°C.
- Humidity (%): 30-70%.
- Photoperiod (hrs dark / hrs light): 12 hrs dark / 12 hrs light.

Test system

Type of coverage:
not specified
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g.
Gauze patches were moistened before application with distilled water containing 0.5% carboxymethylcellulose and 0.1% polysorbate 80 (prepared by Pharmaceuticals Division, Ciba-Geigy Ltd.).
Duration of treatment / exposure:
4 hours.
Observation period:
The skin reactions were evaluated 1, 24, 48, and 72 hours after removing the gauze patches according to the OECD scoring system.
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: An area of at least 36 cm^2 was shaved on both flanks of the animals approximately 24 hours before treatment. A gauze patch was 20 cm.
- Type of wrap if used: The patches were loosely covered with an aluminum foil (36 cm^2) and held in place for 4 hours by an adhesive tape (Isoplast, Isoplast AG, CH-5200 Brugg).


REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 4 hours.


SCORING SYSTEM: OECD scoring system (OECD guideline No. 404); EC classification (EC Directive No. 83/467/ July 29, 1983).

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24-72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24-72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 24-72 h
Score:
1
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 24-72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 24-72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 24-72 h
Score:
0
Max. score:
4
Other effects:
Grade 1 erythema was noted in one animal at 1 hour. No skin
reactions were observed. Individual body weights reported at start and end of test.

Any other information on results incl. tables

Table 1 Individual skin reaction score

 

 

Erythema

Edema

 animal No.

37/M

CF/TF

3 8/M

CF/TF

3 9/M

CF/TF

37/M

CF/TF

38/M

CF/TF

3 9/M

CF/TF

after 1' hr.

0/0

0/0

0/1

0/0

0/0

0/0

after 24 hrs.

0/0

0/0

0/0

0/0

0/0

0/0

after 48 hrs.

0/0

0/0

0/0

0/0

0/0

0/0

after 72 hrs.

0/0

0/0

0/0

0/0

0/0

0/0

mean 24-72 hrs.

0/0

0/0

0/0

0/0

0/0

0/0

CF = control flank TF = test flank

M = male

Applicant's summary and conclusion

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

Under the experimental conditions the substance induced slight erythema when applied to the clipped albino rabbit skin. There reactions were observed only one hour after removing the bandages. Because the mean values of the recordings 24 to 72 hours after application are scored zero, the test item can be classified as non-irritant according to the EC Directive No. 83/467/1983.