Registration Dossier

Toxicological information

Skin irritation / corrosion

Currently viewing:

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

Resultsopen allclose all
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
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
Irritation parameter:
edema score
Basis:
animal: 601
Time point:
other: 1 hr
Score:
3
Max. score:
3
Reversibility:
fully reversible within: 72 hrs
Irritation parameter:
edema score
Basis:
animal: 601
Time point:
24/48 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 72 hrs
Irritation parameter:
edema score
Basis:
animal: 603, 605
Time point:
other: 1 hr
Score:
2
Max. score:
2
Reversibility:
fully reversible within: 48 hrs
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.