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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:
Sep. 26 - Oct. 01, 2007
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report Date:
2007

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
April 2002
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
Test material form:
other: Liquid
Details on test material:
- Name of test material (as cited in study report): Termamyl SC, PPY23880
- Substance type: UVCB
- Physical state: liquid
- Lot/batch No.: PPY 23880
- Expiration date of the lot/batch: At least stable until 20 April 2014
- pH = 7.6
- Stability under test conditions: The test material is stable for at least 24 hours at room temperature
- Storage condition of test material: minus 20 degrees of Celcius

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Bred by Charles River, Germany
- Weight at study initiation: between 1906 - 2174 g
- Age at study initiation: Adults
- Housing: Individually, in animal room with control of temperature (22-23°C) and humidity (50-70%RH)
- Diet (e.g. ad libitum): Standard diet ad libitum
- Air changes (per hr): 10 per hr
- Water (e.g. ad libitum): Tap water ad libitum
- Acclimation period: 5 days
- Photoperiod (hrs dark / hrs light): 12 hrs/12hrs

IN-LIFE DATES: From: 2007-10-01 To: 2007-10-04

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
other: Tested neat
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): undiluted, i.e. 60 mg total protein/mL
Duration of treatment / exposure:
4 hours
Observation period:
72 hrs
Number of animals:
3
Details on study design:
The test compound alpha-amylase was assessed by semiocclusive application of 0.5 mL of the test material formulation to an area of 2.5 x 2.5 cm on the closely-clipped flank of three male New Zealand White rabbits for 4 hrs.
The study was conducted to comply with the following guidelines:
- Organisation for Economic Co-operation and Development (OECD) test guideline 404.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 0.3
Max. score:
1
Reversibility:
fully reversible within: 48 h
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
ca. 0.3
Max. score:
1
Reversibility:
fully reversible within: 48 h
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: Mean 24, 48, 72 h
Score:
ca. 0.3
Max. score:
1
Reversibility:
fully reversible within: 48 h
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: Mean 24, 48, 72 h
Score:
0
Max. score:
0
Irritant / corrosive response data:
At 1 h and 24 h after removal of the test material, very slight erythema was observed in the three rabbits. No erythema was observed at the 48 and 72 h reading. No oedema was observed at the test sites at any of the three rabbits at any of the examinations 1 hour, 24, 48 or 72 hours after termination of exposure.
Other effects:
No other effects.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test material alpha-amylase is not irritating to (human) skin.
Executive summary:

The acute dermal irritant effect of alpha-amylase was investigated according to the method recommended in the OECD Guideline No 404, “Acute Dermal Irritation/Corrosion”. The study was conducted in accordance with GLP.

The study was performed on three male New Zealand White rabbits. They were each exposed to 0.5 mL of the undiluted liquid test item applied under semiocclusive conditions to each of three closely-clipped test sites, 2.5 x 2.5 cm, on the flank. After a 4 -hour exposure period, the test item was removed from the test site and the skin was examined. Only very slight erythema was noted at 1 h and 24 h after removal of the test material, whereas eschar formation or oedema was not observed at any of the test sites at any of the examinations. All reactions were fully reversible and no erythema was observed at the test or control sites of any of the animals at the examinations at 48 or 72 hours after termination of exposure.

The Test Item Mean Score for erythema after 4hrs of exposure to the test item was: 0.3

The Test Item Mean Score for oedema after 4hrs of exposure to the test item was: 0.0

In conclusion, alpha-amylase was not irritating to skin and shall be classified as non-irritant.