3,3,5,7,7-pentamethyl-1,2,4-trioxepane

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2005

Report date:

2005

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Reference

Name:

Unnamed

Type:

Constituent

Test material form:

liquid

Test animals

Species:

rabbit

Strain:

New Zealand White

Remarks:

SPF-Quality

Details on test animals or test system and environmental conditions:

3 males, animals used within the study were at least 6 weeks old and body weights were at least 1.0 kg.

Conditions:
Animals were housed in a controlled environment, in which optimal conditions were considered to be approximately 15 air changes per hour, a temperature of 21.0 +/- 3.0 oC (actual range: 19.4-21.4 oC), a relative humidity of 30-70% (actual range: 25-63%) and 12 hours artificial fluorescent light and 12 hours darkness per day.

Accomodation:
Individually in labelled cages with perforated floors (Scanbur, Denmark, dimensions 56x44x37.5 cm). Acclimatisation period was at least 5 days before start of treatment under laboratory conditions.

Diet:
Standard laboratory rabbit diet (Charles River Breeding and Maintenance Diet for Rabbits, Altromin, Lage, Germany) approx. 100 g. per day. Hay (BMI, Helmond, The Netherlands) was provided at least three times a week.

Water:
Free access to tap water.

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

yes

Amount / concentration applied:

0.5 ml applied onto clipped skin

Duration of treatment / exposure:

4 hours

Observation period:

1, 24, 48 and 72 hours and 7 days after exposure

Number of animals:

three

Details on study design:

Observations:
Mortality/Viability: Twice daily
Toxicity: At least once daily
Body weight: Day of treatment (prior to application) and at termination
Irritation: The skin reactions were assessed at approximately 1, 24, 48, and 72 hours and 7 days after the removal of dressings and test substance. One animal was inadvertendly observed at 69.5 instead of 72 hours after exposure. The irritation scores and a description of all other (local) effects were recorded. Adjacent areas of the untreated skin of each animal served as controls.
Histopathology: none

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal: 601, 603, 605

Time point:

other: 1/24 hrs

Score:

2

Max. score:

2

Reversibility:

fully reversible within: 7 days

Results 2

Irritation parameter:

erythema score

Basis:

animal: 601, 603, 605

Time point:

other: 48/72 hrs

Score:

1

Max. score:

2

Reversibility:

fully reversible within: 7 days

Results 3

Irritation parameter:

edema score

Basis:

animal: 601

Time point:

other: 1 hr

Score:

3

Max. score:

3

Reversibility:

fully reversible within: 72 hrs

Results 4

Irritation parameter:

edema score

Basis:

animal: 601

Time point:

24/48 h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 72 hrs

Results 5

Irritation parameter:

edema score

Basis:

animal: 603, 605

Time point:

other: 1 hr

Score:

2

Max. score:

2

Reversibility:

fully reversible within: 48 hrs

Results 6

Irritation parameter:

edema score

Basis:

animal: 603, 605

Time point:

24 h

Score:

1

Max. score:

2

Reversibility:

fully reversible within: 48 hrs

Irritant / corrosive response data:

Irritation:
Four hours exposure to 0.5 ml of pentamethyl-trioxepane resulted in well defined erythema and slight or moderate oedema in the treated skin-areas of the three rabbits. At 69.5/72 hrs the erythema was only observed at the edges of the application area. The skin irritation had resolved within 7 days after exposure in all animals.

Corrosion:
There was no evidence of a corrosive effect on the skin.

Colouration/Remnants:
No staining of the treated skin by the test substance was observed. Dry remnants of the test substance were present at the edges of the application-area of all rabbits during the observation period.

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

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Based on these results pentamethyl-trioxepane does not have to be classified and has no obligatory labelling requirement for skin irriation.

Executive summary:

Based on these results pentamethyl-trioxepane does not have to be classified and has no obligatory labelling requirement for skin irriation.