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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:
1998-10-20 tp 1998-11-10
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study; OECD and EU guidelines were followed
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report Date:
1999

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
adopted 1992
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Version / remarks:
1992
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Broekman Institute, Someren, The Netherlands
- Age at study initiation: 7-8 weeks old
- Weight at study initiation: 1260-1650 g
- Housing: individually housed in labelled cages with perforated floors
- Diet: standard laboratory rabbit diet; approx. 100 g per day
- Water: Free access to tap-waterdiluted with decalcified water.
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 21 °C
- Humidity: 50 %
- Air changes: 15 air changes per hour
- Photoperiod: 12 hours artificial fluorescent light and 12 hours dark per day

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.5 mL

Duration of treatment / exposure:
4 hours
Observation period:
1, 24, 48 and 72 hours and 7 and 14 days
Number of animals:
3 male rabbits
Details on study design:
TEST SITE
- Area of exposure: 6 square centimeters
- Type of wrap if used: Metalline patch

REMOVAL OF TEST SUBSTANCE
- Washing: The dressing was removed and the remaining test item removed using a tissue moistened with tap-water and subsequently a dry tissue.
- Time after start of exposure: 4 hours

SCORING SYSTEM: according to guidelines

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
no. 1379
Time point:
other: 24, 48, 72 hours
Score:
2.7
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
no.1383
Time point:
other: 24, 48, 72 hours
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
no. 1384
Time point:
other: 24, 48, 72 hours
Score:
2.3
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
2.3
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
no. 1379
Time point:
other: 24, 48, 72 hours
Score:
3
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
no. 1383
Time point:
other: 24, 48, 72 hours
Score:
2.3
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
no.1384
Time point:
other: 24, 48, 72 hours
Score:
2.7
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
2.7
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritant / corrosive response data:
Irritation:
Four hours exposure to 0.5 mL of the test item resulted in well defined or moderate to severe erythema and moderate to severe oedema in the treated skin-areas of the three rabbits. The skin irritation had resolved within 14 days after exposure in all animals. Reduced flexibility of the skin was present in one animal after 72 hours. Bald skin at the edges of the application-area and/or scaliness were observed among the animals between 7 and 14 days after exposure.

Corrosion:
There was no evidence of a corrosive effect o the skin.
Other effects:
Colouration:
No staining of the treated skin by the test item was observed.

Toxicity/Mortality:
No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occured.

Applicant's summary and conclusion

Interpretation of results:
Category II
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In an in vivo skin irritation study with rabbits, TBPPI was shown to be irritating to the skin.
Executive summary:

Primary skin irritaton/corrosion study with tert-butyl peroxypivalate in rabbit (4 -hour semi-occlusive application) according to EU method B.4 and OECD guideline no. 404. Three rabbits were exposed to 0.5 mL of tert-butyl peroxypivalate, applied onto clipped skin for 4 hours using a semi-occlusive dressing. Obersations were made 1, 24, 48 and 72 hours and 7 and 14 days after exposure.

Exposure to tert-butyl peroxypivalate resulted in well defined or moderate to severe erythema and moderate or severe oedema in the treated skin-aeras of the three rabbits with mean erythema score of 2.3 and mean edema score of 2.7.

The skin irritation had resolved within 14 days after exposure in all animals.

Reduced flexibility of the skin was present in one animal after 72 hours. Bald skin at the edges of the application-area and/or scaliness were observed among the animals between 7 and 14 days after exposure.

No evidence of full thickness destruction of the skin or scar tissue was observed during the observation period, indicating that no corrosion of the skin had occured by dermal application of tert-butyl peroxypivalate to intact rabbit skin. Thus, the substance was evaluated to be skin irritating.