Registration Dossier
Registration Dossier
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EC number: 468-890-7 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2002-11-12 to to 2003-04-01
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- adopted 24 April 2002
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- 29 December 1992
- Deviations:
- no
- GLP compliance:
- yes
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Wiga GmbH, Kißlegg, Germany
- Age at study initiation: approx. 17 weeks
- Weight at study initiation: 2.24 to 2.82 kg
- Housing: separately in special rabbit cages (Becker, type K99/30 KU, floor area approx. 5400 cm2, a shelter with an integrated sitting board of 1820 cm2; overall height: 60cm) with plastic grids placed on mobile racks.
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: more than 7 days
ENVIRONMENTAL CONDITIONS
- Temperature: 18-20°C
- Humidity: 42-58%
- Photoperiod: 12 hrs dark / 12 hrs light
IN-LIFE DATES: From: 2002-11-19 To: 2002-11-28
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0,5 ml/animal
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 30-60 min, 24, 48, 72 hours after removal of patches up to day 8
- Number of animals:
- 3 rabbits (females)
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm^2
- % coverage: 100
- Type of wrap if used: semiocclusive
REMOVAL OF TEST SUBSTANCE
- Type: wipe off dry
- Washing: no
- Time after start of exposure: 4h
SCORING SYSTEM: Draize
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- No irritation was observed.
- Other effects:
- - Other adverse local effects:
no signs of irritation or other local effects
- Other adverse systemic effects: no clinical signs, no mortality, no effects on body weight development
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test material was not irritating to the skin in this in vivo test in rabbits according to OECD TG 404
- Executive summary:
Purpose
The purpose of this assay was to identify the skin irritation/corrosion potential of the test item when applied to the intact skin of previously shaven rabbits for a 4 hours period under semiocclusive conditions. This study should provide a rational basis for risk assessment to the irritating potential of the test item in man.
Study Design
To test for primary skin irritation, 0.5 mL of the test material was spread onto 6 cm2 patches and applied to the intact skin of previously shaven rabbits for a 4 hours period under semiocclusive conditions. The first examination of the treated skin sites followed 1 hour after removal of the patches. Thereafter, examinations were performed after 24, 48, and 72 hours.
Results
Under the conditions of the present study no signs of irritation were seen.The evaluation of the mean scores yields zero at all time points investigated.
Conclusion
No skin irritating potential could be detected, thus the test item should not be classified as a skin irritant according to EU Directive 67/548/EC amended and repealed by EU Regulation No. 1272/2008 and CLP.
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