Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2000
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:
2000
Report Date:
2000

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source:Elevage Cunicole de Val de Selle, 80160 Prouzel, France
- Weight at study initiation: 2.6 to 2.9 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 moistered 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
Time point:
other: 1, 24, 48, 72 h
Score:
0
Max. score:
4
Remarks on result:
other: 3 minutes application
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 1, 24,48, 72 h
Score:
0
Max. score:
4
Remarks on result:
other: 3 minutes application
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 1, 24, 48 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: 4 hour application
Irritation parameter:
erythema score
Basis:
animal: #2 and 3
Time point:
other: 1 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 24 hours
Remarks on result:
other: 4 hour application
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
Other effects:
After the 3 minutes application in one animal a brownish coloration of the skin was observed which could have masked a slight red coloration of the skin. After the 4 hour application, this effect was not observed.

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 CTFEP (purity 91.4%) to rabbit (New Zealand White) was determined in a GLP compliant test according to OECD 404 and EU Method B.4 (Griffon 2000). 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 (approx. weight of 2591 to 2854 g on day 1) 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), except for a brown coloration of the skin which could have masked a very slight erythema on day 1, no cutanous reactions were observed. After a 4 hour exposure (three animals), a very slight erythema was observed in all animals on day 1, it persisted in one of them up to day 3.

 

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 laid down in the Commission Directive 93/21/EEC the test item is not required to be classified as irritating to the skin.