Registration Dossier

Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2005
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)
Version / remarks:
2002
Deviations:
no
Remarks:
No deviations occurred that impacted the integrity of the study.
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
Novec 7300
IUPAC Name:
Novec 7300
Details on test material:
- Name of test material (as cited in study report): Novec 7300
- Physical state: Colorless, clear liquid
- Analytical purity: 99.85%
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 3M Company, Batch 41-2601-2240-7
- Expiration date of the lot/batch: 23 March, 2006
- Purity test date: 10 June, 2005

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: At room temperature in the dark

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: None, applied neat.

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Deutschland, Kisslegg, Germany
- Age at study initiation: about 6 weeks old
- Weight at study initiation: at least 1.0 kg
- Housing: Individually labelled cages with perforated floors.
- Diet (e.g. ad libitum): Standard laboratory rabbit diet (Charles River Breeding and Maintenance Diet for Rabbits, Altromin, Lage, Germany), approximately 100 grams per day. Hay was provided at least three times a week.
- Water (e.g. ad libitum): Tap water, ad libitum.
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.3-21.4 C
- Humidity (%): 27-74$
- Air changes (per hr): 15 per hour
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 19 April, 2005 To: 06 May, 2005

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL

VEHICLE : None
Duration of treatment / exposure:
4 h
Observation period:
72 hours
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: Dorsal
- % coverage: 2 x 3 cm
- Type of wrap if used: Coban

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Tap water
- Time after start of exposure: 4 days

OBSERVATION TIME POINTS
1, 24, 48 and 72 hours after exposure.

SCORING SYSTEM:
- Method of calculation: Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Reversibility:
fully reversible
Irritant / corrosive response data:
Reversibility of any observed effect: Changes fully reversible within 1 days
Other effects:
None.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Based on the result of the study, the test article is considered non-irritating to the skin.
Executive summary:

The skin irritation potential of the test material was evaluated in New Zealand White rabbits. The study was conducted in compliance with OECD GLP (1997) regulations. The test method was based on OECD No. 404 (2002); EC Directive 67/548/EEC, An.V, B.4 (2004); OPPTS 870.2500 (1998); JMAFF Guidelines (2000) Three rabbits were exposed to 0.5 ml of the test article (liquid - dosed undiluted) applied to clipped skin for 4 hours using a semi-occlusive dressing. Skin reactions were assessed at 1, 24, 48, and 72 hours after exposure. Exposure to the test article resulted in very slight edema in the treated skin areas of 2 rabbits which resolved by 24 hours. Based on the result of the study, the test article is considered non-irritating to the skin.

Categories Display