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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2006
Report date:
2006

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
Test material form:
solid: particulate/powder
Details on test material:
Light pink tinted powder
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: provided by Syngenta, batch number 4, Syngenta CTL number T12511/002
- Expiration date of the lot/batch: n/a
- Purity test date: not specified


STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temp in the dark
- Stability under test conditions: stable
- Solubility and stability of the test substance in the solvent/vehicle: not soluble in water
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium:

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing:
- Preliminary purification step (if any):
- Final dilution of a dissolved solid, stock liquid or gel:
- Final preparation of a solid:

FORM AS APPLIED IN THE TEST (if different from that of starting material)

TYPE OF BIOCIDE/PESTICIDE FORMULATION (if applicable)

OTHER SPECIFICS:

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: David Percivle Limited. Moston, Sandbach, Cheshire, UK.
- Age at study initiation: 12 to 20 weeks old.
- Weight at study initiation: 2.0 to 3.5kg
- Housing: Individually house in suspended cages.
- Diet (e.g. ad libitum): Certified rabbit diet (code 5322)
- Water (e.g. ad libitum): Mains drinking water
- Acclimation period: Minimum 5 days each animal

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 to 23
- Humidity (%): 30 to 70
- Air changes (per hr): 15 changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours light, 12 hours dark

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
other: The test material moistened with distilled water.
Amount / concentration applied:
EST MATERIAL
- Amount(s) applied (volume or weight with unit): 500mg
- Concentration (if solution): n/a

VEHICLE
- Amount(s) applied (volume or weight with unit): sample moistened with 0.5ml of distilled water
- Concentration (if solution): n/a
- Lot/batch no. (if required): n/a
- Purity: n/a

NEGATIVE CONTROL
- Amount(s) applied (volume or weight): n/a
- Concentration (if solution): n/a

POSITIVE CONTROL
- Amount(s) applied (volume or weight): n/a
- Concentration (if solution): n/a
Duration of treatment / exposure:
4 h
Observation period:
1 hour, 24 hours, 48 hours and 72 hours after application
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: Dorsal/flank area

REMOVAL OF TEST SUBSTANCE
- Washing (if done): gentle swabbng with cotton wool and distilled water
- Time after start of exposure: 4 hours

OBSERVATION TIME POINTS
(indicate if minutes, hours or days) 1 hour, 24 hours, 48 hours and 72 hours after removal of patches.

SCORING SYSTEM:
- Method of calculation: Draize J H (1959) "Dermal Toxicity" In: Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics. Association of Food and Drug Officials of the United States, Austin, Texas, p.47

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24 h
Score:
0
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
48 h
Score:
0
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
72 h
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24 h
Score:
0
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
48 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
72 h
Score:
0
Max. score:
0
Reversibility:
other: no indication of irritation
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24 h
Score:
0
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
72 h
Score:
0
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: no indication of irritation
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: no indication of irritation
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: no indication of irritation
Remarks on result:
no indication of irritation
Other effects:
No evidence of skin irritation was noted during the study.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met