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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
07-07-1994 to 16-03-1995
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report Date:
1995

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
1992
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
Test material form:
liquid
Details on test material:
- Lot/batch No.: PPA4800
- Expiration date of the lot/batch: 10-05-2004

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River (UK) Limited
- Weight at study initiation: 3.17 - 3.67 kg
- Housing: Housed in suspended stainless steel cages mounted in mobile batteries.
- Diet (e.g. ad libitum): Standard pelleted rabbit diet STANRAB (P) SQC

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18°C (range 15°C - 23°C)
- Humidity (%): 55% (40% - 70%)

IN-LIFE DATES: From: 1994-11-15 To: 1994-11-18

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
Duration of treatment / exposure:
4 hours
Observation period:
1 hour, 24 hours, 48 hours and 72 hours.
Number of animals:
6 (3 males and 3 females)
Details on study design:
TEST SITE
- Area of exposure: 3 x 2 cm
- Type of wrap if used: gauze patch held in place by strips of Blenderm. The control was covered by a similar semi-occlusive dressing but otherwise remained untreated.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Not specified
- Time after start of exposure: 5 hours

OBSERVATION TIME POINTS
1 hour, 24 hours, 48 hours and 72 hours.

SCORING SYSTEM:

Erythema and eschar formation
No erythema ....................................................................................................................................0
Very slight erythema (barely perceptible) .......................................................................................1
Well-defined erythema .....................................................................................................................2
Moderate to severe erythema ..........................................................................................................3
Severe erythema (beet redness) to slight eschar formations (injuries in the depth) ......................4

Edema formation
No edema ..........................................................................................................................................0
Very slight edema (barely perceptible) ............................................................................................1
Slight edema (edges of area well-defined by definite raising) .........................................................2
Moderate edema (raised approximately 1 mm) .................................................................................3
Severe edema (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
Remarks:
Intact skin
Basis:
animal: all animals
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Remarks:
Intact skin
Basis:
animal: all animals
Time point:
24/48/72 h
Score:
0
Max. score:
0

Applicant's summary and conclusion

Interpretation of results:
not irritating
Conclusions:
Under the conditions of this test and the criteria of the EEC, neutrase was classified as 'non-irritant' to skin. The formulation had a dry matter content of 23.4% and a total organic solids content of 16.1%.
Executive summary:

The potential of the retail concentration of neutrase PPA 4800, hereafter referred to as neutrase, to cause inflammatory or corrosive changes upon first contact with skin was assessed by semi-occluded application of 0.5 mL of the test material formulation to the closely-clipped dorsa of three New Zealand White rabbits for five hours. Dermal reactions were assessed 1, 24, 48 and 72 hours after removal of the dressings. No dermal irritation response was observed at the test site of any rabbit at any time during the 72-hour observation period.

Under the conditions of this test and the criteria of the EEC, neutrase was classified as 'non-irritant' to skin. The formulation had a dry matter content of 23.4% and a total organic solids content of 16.1%.