Registration Dossier
Registration Dossier
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EC number: 434-850-2 | CAS number: 1680-31-5
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1999-07-06 to 1999-07-28
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- January 1997
- Deviations:
- no
- GLP compliance:
- yes
Test material
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: Mol:Russian
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Mollegaard Breeding and Research Centre AIS, Ejby, DK-4623 Lilie Skensved
- Housing: animal room
- Diet: Rabbit diet "Altromin 2123" (supplier: Altromin, D-32791 Lage, Lippe, Germany) was available ad libitum.
- Water: domestic quality drinking water acidified with hydrochloric acid to pH 2.5 in order to prevent microbial growth, ad libitum
- Acclimation period: ca. 1 week
ENVIRONMENTAL CONDITIONS
- Temperature: 20 °C ± 3 °C
- Humidity: 55 % ± 15 %
- Air changes: 10 times/hour
- Photoperiod: 12 hours light and 12 hours darkness
IN-LIFE DATES: From: 1999-07-06 To:1999-07-28
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.5 mL of the test article - Duration of treatment / exposure:
- 4 h
- Observation period:
- 21 days
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: 2.5 cm wide adhesive Gothaplast tape and fixed with Gothaplast tape, 5 cm width, loosely wound round the trunk
REMOVAL OF TEST SUBSTANCE
- Washing: mild soap and lukewarm water
- Time after start of exposure: 1, 24, 48, 72
SCORING SYSTEM:
According to the directive ofthe EEC commission 93/21/EEC of May 4, 1993
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 24, 48, 72 h
- Score:
- 0.17
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- other: mean individual score
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 24, 48, 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 h
- Remarks on result:
- other: mean individual score
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 24, 48, 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 h
- Remarks on result:
- other: mean individual score
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 h
- Remarks on result:
- other: mean individual score
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no skin irritation visible
- Remarks on result:
- other: mean individual score
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: 24, 48, 72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- other: mean individual score
- Irritant / corrosive response data:
- Very slight skin reactions were observed among the rabbits. These reactions were not complete reversible in one animal 21 days after application of the test article. Based on the experimental data the test item has not be classified as skin irritating.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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