Registration Dossier
Registration Dossier
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EC number: 451-520-3 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation / corrosion
- Adequacy of study:
- other information
Data source
Reference
- Reference Type:
- other: Body responsible for the test
- Title:
- Unnamed
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Principles of method if other than guideline:
- Organisation for Economic Co-operation and Development
(OECD), OECD Guidelines for Testing of Chemicals, Section 4,
Health Effects, No.404: "Acute Dermal Irritation /
Corrosion", Paris Cedex, 2002.
European Community (EC), Council Directive 67/548/EEC, Annex
V, Part B, Methods for the Determination of Toxicity, as
last amended by Commission Directive 92/69/EEC, B.4: "Acute
Toxicity - Skin Irritation". Official Journal of the
European Communities No. L 383, 1992
United States Environmental Protection Agency (EPA). Health
Effects Test Guidelines, OPPTS 870.2500, Acute Dermal
Irritation. Office of Prevention, Pesticides and Toxic
Substances (7101), EPA 712-C-98-196, August 1998.
Japanese Ministry of Agriculture, Forestry and Fisheries
(JMAFF), 12 Nousan, Notification No 8147, November 2000,
including the most recent partial revisions. - GLP compliance:
- yes
Test animals
- Species:
- other: Albino rabbit, New Zealand White
Test system
- Type of coverage:
- semiocclusive
- Vehicle:
- other: Corn oil.
- Amount / concentration applied:
- 500 mg
- Duration of treatment / exposure:
- 4 h
- Number of animals:
- 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- (mean score 1)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- (mean score 2)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- (mean score 3)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Irritation parameter:
- erythema score
- Max. score:
- 1
- Remarks on result:
- other: Max. duration: 1 d; Max. value at end of observation period: 0 (related to all animals)
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- (mean score 1)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- (mean score 2)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- (mean score 3)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Irritation parameter:
- edema score
- Max. score:
- 0
- Remarks on result:
- other: Max. duration: 0 d; Max. value at end of observation period: 0 (related to all animals)
- Irritant / corrosive response data:
- Reversibility of any observed effect: Changes fully reversible within 1 days
- Other effects:
- Exposure to the test substance resulted in very slight
erythema in the treated skin-areas of the three rabbits
noted at the one hour observation period only.
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified
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