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EC number: 292-053-3 | CAS number: 90530-15-7
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Sept 19 1983 - Nov 1 1983
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was carried out according to OECD 404.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 983
- Report date:
- 1983
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Principles of method if other than guideline:
- same as guideline
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Hardener V 217
- IUPAC Name:
- Hardener V 217
- Test material form:
- other: yellowish li
- Details on test material:
- - Name of test material (as cited in study report): Hardener V 217
- Physical state: liquid
- Analytical purity: 100%
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: small white Russian, Chbb-SPF
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Dr Karl Thomae Gmbh, Biberach
- Male and female: 3 of each
- Weight at study initiation: 2.2 - 2.5kg
- Housing: individual housing in stainless steel cages
- Diet: ad libitum - K4 complete feed for rabbits, Ssniff Versuchstier-Diäten Gmbh, 4770 Soest
- Water: ad libitum - tap water
- Acclimation period: 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20+/- 1°C
- Humidity (%): 60 +/- 5%
- Air changes (per hr): 15 changes per hour
- Photoperiod (hrs dark / hrs light): 12-hour light/dark rhythm
IN-LIFE DATES: From: Oct 4 1983 To: Oct 28 1983
Test system
- Type of coverage:
- other: patch test
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.5ml on approx. 6 cm²
- Concentration: 100% - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 1 and 24 hours after removal of dressing
after 48 and 72 hours and 6, 8, 10, 13 16, 20 and 24 days - Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: 6 cm²
- % coverage: 2.5x2.5cm
- Type of wrap if used: linen patch covered with polyethylene film
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with distilled water
- Time after start of exposure: 4 hours
SCORING SYSTEM: see tab with other information
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 6d
- Remarks on result:
- probability of severe irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 6d
- Remarks on result:
- probability of severe irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 6d
- Remarks on result:
- probability of severe irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 6d
- Remarks on result:
- probability of severe irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 6d
- Remarks on result:
- probability of severe irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 6d
- Remarks on result:
- probability of severe irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Max. score:
- 1
- Reversibility:
- fully reversible within: 6d
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible within: 6d
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Max. score:
- 1
- Reversibility:
- fully reversible within: 6d
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no effects observed
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible within: 6d
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible within: 6d
- Irritant / corrosive response data:
- see attached results
- Other effects:
- necrosis developed in the area of application on all animals 1 hour to 3 days after removing the patch. after 8-13 days, hard, reddish-brown scabs developed in the area of application, and these detached on days 16-20, and scarred structures remained after 24 days.
Any other information on results incl. tables
see attached results
Applicant's summary and conclusion
- Interpretation of results:
- corrosive
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Hardener V 217 showed a moderately irritant effect (index 4.42/8) on the skin of male and female rabbits. Because necrosis occured, it is necessary for the evaluation to be quoted as extremely irritant of corrosive.
- Executive summary:
In order to test the acute skin irritation effect, Hardener V 217 was applied to the shaven dorsal skin or rabbits. The product was admintsered undiluted, and the exposure time in the patch test was 4 hours.
Result: Hardener V 217 showed a moderately irritant effect (index 4.42/8) on the skin of male and female rabbits. Because necrosis occured, it is necessary for the evaluation to be quoted as extremely irritant of corrosive.
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