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Registration Dossier
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EC number: 205-087-0 | CAS number: 133-06-2
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 7 August 1991 to 10 August 1991
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 1981
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- 1984
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Captan
- EC Number:
- 205-087-0
- EC Name:
- Captan
- Cas Number:
- 133-06-2
- Molecular formula:
- C9H8Cl3NO2S
- IUPAC Name:
- 2-[(trichloromethyl)sulfanyl]-2,3,3a,4,7,7a-hexahydro-1H-isoindole-1,3-dione
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- - Physical state: white powder
- Purity: 90.5 %
- Batch number: 4102 L/7
- Date of arrival: 9 July 1991
- Storage conditions: room temperature
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- - three New Zealand white rabbits
- Source: David Percival Ltd., Moston, Sandbach, Cheshire, U.K.
- weight: 2.34 - 2.88 kg
- age: twelve to sixteen weeks old
- free access to mains drinking water and food
- animal room temperature: 20 - 23°C- relative humidity: 60 - 66%
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Controls:
- no
- Amount / concentration applied:
- A quantity of 0.5 g of the test material, moistened with 0.5 ml of distilled water, was introduced under a 2.5 cm x 2,5 cm gauze patch and placed In position on the shorn skin.
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- One hour following the removal of the patches, and 1, 24, 48 and 72 hours later, the test sites were examined for evidence of primary irritation and scored according to the scale from Draize J.H. (1959).
- Number of animals:
- three
- Details on study design:
- Captan was applied as a single 0.5 g dermal dose to three New Zealand White rabbits. The test substance, moistened with 0.5 mL distilled water was introduced under a 2.5 x 2.5 cm gauze patch onto shorn skin. After four hours the patch was removed and any residual test material removed. The areawas examined at 1, 24, 48 and 72 hours after the removal of the patch and scored according to Draize (1959).
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: 1 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: 1 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 1 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 1 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 1 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 1 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- animal: #1, #2, #3
- Time point:
- other: 24/72 h
- Score:
- 0.5
- Max. score:
- 8
- Reversibility:
- fully reversible
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
Any other information on results incl. tables
The individual scores for erythema/eschar and oedema, are given in Table 7.3.1 -1. Very slight erythema was noted at all treated skin sites one and 24 hours after patch removal and at one treated skin site at the 48-hour observation. All treated skin sites appeared normal 72 hours after treatment.
Table 7.3.1 -1 Dermal irritation responses in rabbits: individual dermal responses
Animal No. |
|
| 52 | 54 | 55 | Mean scores |
Draize grade after | 1 h | O | 0 | 0 | 01 |
|
E | 1 | 1 | 1 | |||
24 h | O | 0 | 0 | 0 | ||
E | 1 | 1 | 1 | |||
48 h | O | 0 | 0 | 0 | ||
E | 0 | 1 | 0 | |||
72 h | O | 0 | 0 | 0 | ||
E | 0 | 0 | 0 | |||
| mean1 | O | 0 | 0 | 0 | |
E | 0.33 | 0.66 | 0.33 | |||
Overall average means1 | O | 0 | ||||
| E | 0.44 | ||||
O = oedema.
E = erythema and eschar formation.
1Mean for individual animals over three time points 24, 48 and 72 hours
for each lesion, calculated as mean score at (24 hours + 48 hours + 72 hours)/3.
Applicant's summary and conclusion
- Interpretation of results:
- Category 3 (mild irritant) based on GHS criteria
- Conclusions:
- On the basis of the degree of skin reaction observed (mean skin irritation scores 24 to 72 hours after removal of test substance) and in accordance with the provisions of regulation 1272/2008, Annex I, 3.2, captan is not classified as irritating to rabbit skin.
- Executive summary:
A study was performed to assess the irritancy potential of the test material to the skin of the New Zealand White rabbit. The method used followed that described in the OECD Guidelines for Testing of Chemicals (1981) No. 404 "Acute Dermal Irritation/Corrosion" referenced as EU method B.4 published in the regulation 440/2008.
A single 4-hour, semi-occluded application of the test material to the intact skin of three rabbits produced very slight erythema. All treated skin sites appeared normal 72 hours after treatment.
The test material produced a primary irritation index of 0.5 and was classified as a mild irritant to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.
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