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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2001
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline and GLP compliant study with good documentation.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report date:
2001

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
2-(isopropylthio)-3-(2,2,2-trifluoroethoxy)pyridine
EC Number:
696-441-7
Cas Number:
256473-05-9
Molecular formula:
C10H12F3NOS
IUPAC Name:
2-(isopropylthio)-3-(2,2,2-trifluoroethoxy)pyridine

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source:Elevage Cunicole de Val de Selle, 80160 Prouzel, France
- Weight at study initiation: 2.8 to 3.3 kg/animal
- Housing: individually
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 +/- 3°C
- Humidity (%): 30 - 70%
- Air changes (per hr): 12 cycles/hour
- Photoperiod (hrs dark / hrs light): 12/12 hours

Test system

Type of coverage:
occlusive
Preparation of test site:
other: clipped
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg of the test substance were placed on a dry gauze pad which was then applied to the right flank (application for 4 hours) or the left flank (application for 3 minutes)
Duration of treatment / exposure:
3 minutes and 4 hours
Observation period:
approximately 1 hours, 24, 48, and 72 hours after removal of dressing
Number of animals:
three male animals
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): after removal of the dressing, any residual test item was wiped off by means of a moistened gauze pad.

SCORING SYSTEM:
Commission directive 93/21/EEC of 27 April 1993 adapting to technical progress for the eighteenth time Council Directive 67/548/EEC on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: #1 and #3
Time point:
other: 1, 24, 48, 72 h
Score:
0
Max. score:
4
Remarks on result:
other: 4 hour application
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 1 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 24 h
Remarks on result:
other: very slight effect
Irritation parameter:
edema score
Basis:
animal: # 1, 2, and 3
Time point:
other: 1, 24, 48, 72 h
Score:
0
Max. score:
4
Remarks on result:
other: 4 hour application

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Executive summary:

The acute dermal irritation of ITTFEP (purity 82.3%) to rabbit (New Zealand White) was determined in a GLP compliant test according to OECD 404 and EU Method B.4 (Griffon 2001). Since the study was performed under GLP and according the guideline and based on the good documentation the study was awarded with Klimisch 1. For the acute dermal irritation testing in 3 male rabbits (weight of 2762 to 3282 g on day 0) 500 mg test item was administered to the clipped skin. Application was performed for 3 minutes (animal 1) and 4 hours (animals 1 to 3). The untreated skin served as control.

 

The skin were examined according the EU specifications. After a 3 minutes exposure (one animal) no cutanous reactions were observed. After a 4 hour exposure (three animals), a very slight erythema was observed in animal #2. This very slight effect was only observed 1 hour after removing the dressing.

 

There were no remarkable clinical observations during the study.

 

It can be concluded that under the experimental conditions the test substance is non irritant when administered by dermal route to rabbits.

 

According to the classification criteria set out in Directive 67/548/EEC and Regulation (EC) No. 1272/2008 the substance does not fulfil the criteria for classification as irritant to skin.

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