Registration Dossier

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:
other: The study was carried out in compliance with Directive 92/69/EEC, B.4 "Acute Toxicity - Skin Irritation", 1992.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report Date:
2000

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
Swiss Federal Department of the Interior

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Triol
- Physical state: white solid
- Analytical purity: 99.5 % (LC), 99.8 % (DSC)
- Lot/batch No.: 6262/ZTN/03/N/08/001/003
- Expiration date of the lot/batch: 1 December 2000
- Stability under test conditions: not specified in water
- Storage condition of test material: in refridgerator at 4 +/- 3 °C, protected from sunlight
- Other:

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Elevage Scientifique des Dombes, Chatillon sur Chalaronne, France
- Age at study initiation: 14 weeks
- Weight at study initiation: 2.8 to 3.2 kg
- Housing: individual stainless steel cages
- Diet (e.g. ad libitum): pelleted standard Provimi Kliba 3418 rabbit maintenance diet ad libitum (Provimi Kliba AG, Kaiseraugst, Switzerland)
- Water (e.g. ad libitum): community tap water from Füllinsdorf ad libitum
- Acclimation period: six days under laboratory conditions


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 30-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: To:

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: clipped with an electronic clipper
Vehicle:
other: bi-distilled water
Controls:
no
Amount / concentration applied:
0.5 g (per animal)
Duration of treatment / exposure:
4 hours
Observation period:
72 hours after removal of the patch
Number of animals:
one male, two females
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- % coverage:
- Type of wrap if used: Isoelast Heftpflaster Acryl


REMOVAL OF TEST SUBSTANCE
- Washing (if done): lukewarm tap water
- Time after start of exposure: 4 hours


SCORING SYSTEM: The skin reaction was assessed according to the numerical scoring system listed in the EEC Commission Directive 92/96/EEC, July 31, 1992.

Results and discussion

In vivo

Results
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 72 hours
Score:
0
Max. score:
0
Irritant / corrosive response data:
Local signs (mean values from 24 to 72 hours) consisted of grade 0.00 erythema and grade 0.00 oedema. No irreversible alterations of the treated skin were observed nore were corrosive effects evident on the skin.

Any other information on results incl. tables

Table 1: Individual skin irritation scores.

Animal No.

Sex

Evaluation interval

Erythema

Oedema

25

M

1 hour

0

0

26

F

0

0

27

F

0

0

25

M

24 hours

0

0

26

F

0

0

27

F

0

0

25

M

48 hours

0

0

26

F

0

0

27

F

0

0

25

M

72 hours

0

0

26

F

0

0

27

F

0

0

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based upon the referred classification criteria, Triol is considered to be not irritating to the rabbit skin.
Executive summary:

The primary skin irritation potential of Triol was investigated by a topical semi-occlusive application of 0.5 g to 6 cm2 intact left flank of each of three young adult New Zealand White rabbits according to the OECD Guideline No. 404. The duration of treatment was four hours. The scoring of skin reactions was performed 1, 24, 48 and 72 hours after removal of the dressing. The scores of each animal at the following reading times (24, 48, 72 hours) were used in calculating the respective mean values for each type of lesion.

The test article did no elicit any skin reactions at the application site at any of the observation times (all scores 0). The mean values from 24 to 72 hours were therefore 0 for erythema and 0 for oedema.

The test article caused no staining of the treated skin.

No corrosive effects were noted on the treated skin of any animal at any measuring interval.

Based upon the referred classification criteria (EEC Commission Directive 93/21/EEC of April 27, 1993), Triol is considered to be not irritating to the rabbit skin.