Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2002-09-24 to 2002-10-08
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to the appropriate OECD test guideline, and in compliance with GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2003
Report Date:
2003

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
other: liquid

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan, Horst, The Netherlands
- Age at study initiation: at least 6 weeks old
- Weight at study initiation: at least 1 kg
- Housing: Individually house in labelled cages with perforated floors (Scanbur, Denmark)
- Diet (e.g. ad libitum): approximately 100 g per day (Teklad Global Rabbit Diet, code 2030, Harlan, Blackthron, England); hay provided twice a week (BMI, Helmond, the Netherlands)
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: At least 5 days before start of treatment under laboratory conditions

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21±3°C
- Humidity (%): 30-70%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.5 ml
Duration of treatment / exposure:
4 hours
Observation period:
14 days
Number of animals:
3 male
Details on study design:
TEST SITE
- Area of exposure: 150 cm2 (10x15 cm2)
- % coverage: 4% (2x3cm (6cm2))
- Type of wrap if used: Coban elastic bandage

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

SCORING SYSTEM:
The irritation was assessed according to the following numerical scoring system. At each observation, the highest scores given were recorded:
Erythema and eschar formation:
No erythema - 0
Very slight erythema (barely perceptible) - 1
Well-defined erythema - 3
Severe erythema (beet redness)* - 4
*where signs of necrosis or corrosion (injuries in depth) prevent erythema scoring, the maximum grade is given
Oedema formation:
No oedema - 0
Very slight oedema (barely perceptible) - 1
Slight oedema (edges of area are well-defined by definite raising) - 2
Moderate oedema (raised approximately 1 mm) - 3
Severe oedema (raised more than 1 mm and extending beyond the area of exposure) - 4

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: mean 24-72 hours
Score:
1.3
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: mean 24-72 hours
Score:
1.6
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: mean 24-72 hours
Score:
1.6
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: mean 24-72 hours
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: mean 24-72 hours
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: mean 24-72 hours
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritant / corrosive response data:
Four hours of exposure to 0.5 ml resulted in well-defined erythema and very slight or slight oedema in the treated skin-areas of the three rabbits. Diffuse and speckled erythema was noted in one animal between 24 and 72 hours. The skin irritation had resolved within 14 days after exposure in all animals. Scaliness was observed in two animals after 72 hours and all animals after 7 days.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Dihydro-3-[3-(triethoxysilyl)propyl]furan-2,5-dione has been tested for acute skin irritation in a semi-occlusive study conducted according to OECD TG 404 and in compliance with GLP. Diffuse and speckled erythema was noted in one animal between 24 and 72 hours. The skin irritation had resolved within 14 days after exposure in all animals. It is concluded that the test substance is not irritating to the skin.