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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:
Started January 7, 1986 and terminated on January 21 ,1986.
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:
1986
Report date:
1986

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Reference substance name:
614-45-9 (% unknown)
IUPAC Name:
614-45-9 (% unknown)
Constituent 2
Chemical structure
Reference substance name:
tert-butyl perbenzoate
EC Number:
210-382-2
EC Name:
tert-butyl perbenzoate
Cas Number:
614-45-9
Molecular formula:
C11H14O3
IUPAC Name:
tert-butyl benzenecarboperoxoate
Details on test material:
A 250 g sample of the test substance was received from the sponsor on December 11, 1985. It was a clear, colourless, slightly viscous liquid, designated Trigonox C, no. 4285060690, and it was stated to be t. butylperbenzoate. applied as received

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
Healthy male, young adult, New Zealand White albino rabbits obtained from ENKI-Konijnenfarm, Someren, the Netherlands, were used as the experimental animals. The body weight range was 2500-3500 g. The animals were identified by earmarking.The animals were housed individually in suspended, galvanized cages, fitted with wire-mesh floor and front. The cages were placed in a room, controlled for light (12 hours light/dark cycle), temperature (18+/-3°C), ventilation (c. 10 air changes/hour), and relative humidity (40-70%) throughout the test period. A standard laboratory rabbit diet and tap water were provided ad libitum.

Test system

Type of coverage:
occlusive
Preparation of test site:
other: shaved; abraded and unabraded
Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
0.5 ml per site
Duration of treatment / exposure:
After an exposure period of 4 hours the patches and the test material applied were removed and the resulting skin reactions were evaluated by the method of Draize et a1. (J. Pharmaco1. Exp. Ther. 82 (1944) 377-390).
Observation period:
8 days
Number of animals:
six; male
Details on study design:
After an acclimatization period of six days, i.e. one day prior to the start of the experiment, the hair was removed from the back and flanks of the animals using electric clippers in a way as to avoid abrasions. Six rabbits were treated on the intact skin and on the abraded skin. The abrasions were minor incisions of the stratum corneum, but not sufficiently deep to disturb the derma or to produce bleeding. An amount of 0.5 m1 of the undiluted test substance was brought onto the intact and the abraded skin under a surgical patch measuring 1 inch x 1 inch. The patches were fixed to the application site by means of adhesive tape and the entire trunk of each rabbit was wrapped with an impervious material to maintain the test patches in position and to retard evaporation of the test substance. After an exposure period of 4 hours the patches and the test material applied were removed and the resulting skin reactions were evaluated by the method of Draize et a1. (J. Pharmaco1. Exp. Ther. 82 (1944) 377-390). Further readings were made after 28, 52 and 76 hours.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
3.33
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
3.67
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
fully reversible
Remarks:
8 days
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
3.33
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.67
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible
Remarks:
8 days
Irritation parameter:
edema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
1.67
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
edema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
edema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
1.33
Max. score:
4
Reversibility:
fully reversible within: 8 days

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritant)
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
The test substance generally caused well-defined or moderate erythema and very slight to slight ischemia in all (six) rabbits. In addition, slight scaliness and very slight incrustation was observed in a limited number of animals. The reactions of the abraded skin were slightly more pronounced than those of the intact skin, but all reactions were considered to be reversible. On the basis of the results obtained it was concluded that, according to the EEC-standards*, the undiluted test substance Trigonox C is a primary skin irritant.
* EEC Directive 79-831, Annex V, Part B: Methods for the determination of toxicity, B.4. Acute toxicity, skin irritation, dated December 1983.
Executive summary:

A sample of Trigonox C was examined undiluted for primary skin irritating properties in an experiment with six albino rabbits. The test substance generally caused well-defined or moderate erythema and very slight to slight ischemia in all (six) rabbits. In addition, slight scaliness and very slight incrustation was observed in a limited number of animals. The reactions of the abraded skin were slightly more pronounced than those of the intact skin, but all reactions were considered to be reversible. On the basis of the results obtained it was concluded that, according to the EEC-standards*, the undiluted test substance Trigonox C is a primary skin irritant.

* EEC Directive 79-831, Annex V, Part B: Methods for the determination of toxicity, B.4. Acute toxicity, skin irritation, dated December 1983.