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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:
2009-09-10 to 2010-01-07
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
The in vivo study was conducted under the purpose of another regulation.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report date:
2010

Materials and methods

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

Test material

Constituent 1
Chemical structure
Reference substance name:
tert-butyl 3,5,5-trimethylperoxyhexanoate
EC Number:
236-050-7
EC Name:
tert-butyl 3,5,5-trimethylperoxyhexanoate
Cas Number:
13122-18-4
Molecular formula:
C13H26O3
IUPAC Name:
tert-butyl 3,5,5-tris(methylperoxy)hexanoate

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Deutschland GmbH, D-88353 Kisslegg.
- Age at study initiation: approximately 9 weeks at the time of the administration
- Weight at study initiation: 2.1 kg
- Housing: individual caging in terulan cages
- Diet: ad libitum, Ssniff K-H maintenance diet for rabbits
- Water: ad libitum, tap water from an automatic watering system
- Acclimation period: at least 7 days


ENVIRONMENTAL CONDITIONS
- Temperature: average of about 20 °C
- Humidity: average of 30 - 70 %
- Photoperiod (hrs dark / hrs light): artificial light from 6 a.m. to 6 p.m.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL

Duration of treatment / exposure:
4 hrs
Observation period:
1, 24, 48 and 72 hrs after patch removal
Number of animals:
3 females
Details on study design:
TEST SITE
- Area of exposure: dorsal area of the trunk
- Type of wrap if used: self adhesive non woven fabric, hypoallergenic


Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritant / corrosive response data:
No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.
Other effects:
2/3 animals gained weight in the week p.a. 1/3 animals gained no weight in the week p.a. All areas to be treated with the test substance and all control were normal before the application and at each observation time.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
According to Commission Directive 2001/59/EC tert-Butylperoxy-3,5,5-trimethylhexanoat does not require classification for skin irritation.
Executive summary:

Tert-Butylperoxy-3,5,5-trimethylhexanoat was tested to three rabbits in accordance with the OECD Guideline 404 and the Council (EC) No 440/2008, Method B.4.

0.5 mL tert-Butylperoxy-3,5,5-trimethylhexanoat was applied via a patch to a site of about 2.5 cm x 2.5 cm of the intact skin of each of 3 New Zealand White rabbits and covered by semi-occlusive dressing. The duration of the exposure was 4 hours.

First the test substance was administered to one animal. As no serious skin reactions were noted in this animal, the remaining two animals were exposed to the test substance one week later.

Body weights were investigated at the start and at the termination of the test. The animals were examined once daily for other than local changes of the skin. The treated areas of the animals were examined for erythema/eschar and oedema as well as for other local alterations (such as hyperplasia, scaling, discolouration, fissures, scabs and alopecia) approximately 1, 24, 48 and 72 hours after patch removal.

No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.

Erythema/Eschar: Not observed at any observation point.

Oedema: Not observed at any observation point.

The following mean scores were calculated for each animal from the examinations 24 h, 48 h and 72 h p.a.:

 

Mean Scores for Animal No.

 

41

42

43

Erythema/Eschar

0

0

0

Oedema

0

0

0

According to Commission Directive 2001/59/EC tert-Butylperoxy-3,5,5-trimethylhexanoat does not require classification for skin irritation.