Registration Dossier
Registration Dossier
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EC number: 444-090-3 | CAS number: 204848-45-3
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 29-Nov-2002 to 13-Dec-2002
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: OECD guideline test, GLP compliance
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 on 17th July 1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- 1996
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- Version / remarks:
- adopted in August 1998
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- -
- EC Number:
- 444-090-3
- EC Name:
- -
- Cas Number:
- 204848-45-3
- Molecular formula:
- C44 H43 N3 O4
- IUPAC Name:
- Propanoic acid, 2-[4-[4,6-bis([1,1'-biphenyl]-4-yl)-1,3,5-triazin-2-yl]-3-hydroxyphenoxy]-, isooctyl ester
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan UK Ltd, Bicester, Oxon, England
- Age at study initiation: at least 12 weeks
- Weight at study initiation: 2.77 - 3.18 kg
- Housing: individually in stainless steel cages with perforated floors
- Diet: each rabbit was offered 125 g of a standard laboratoty rabbit diet (Special Diet Services TANRAB (P) SQC pellet) per day; dietary supplement of hay
- Water: drinking water was provided ad libitum
- Acclimation period: at least 46 days
ENVIRONMENTAL CONDITIONS
- Temperature: 20 °C
- Humidity: 40-70%
- Photoperiod : 12 hours dark / 12 hours light
IN-LIFE DATES: not indicated
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- other: a control gauze patch was applied to the contralateral flank
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.5 g - Duration of treatment / exposure:
- 4 hours
- Observation period:
- Examination of the treated skin was made on removal of the dressings (for 3 minute or one hour exposures) and aproximately 1, 24, 48 and 72 hours later
- Number of animals:
- 3 males
- Details on study design:
- TEST SITE
- Area of exposure: 25 mm x 25 mm
- Type of wrap if used: cotton wool and "Tubigrip" elasticated bandage dressing (semi-occlusive)
REMOVAL OF TEST SUBSTANCE
- Washing: with lukewarm water (30-40°C) . The treated area was blotted dry with absorbent paper.
- Time after start of exposure: 4 hours
SCORING SYSTEM: The skin reactions were evaluated according to the OECD scoring system.
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 dermal reaction was observed in any animal throughout the duration of the study.
- Other effects:
- No other effects observed.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Application of the test substance onto skin did not provoke any skin reaction. The substance is therefore not considered to be irritating to skin.
- Executive summary:
A GLP-compliant Acute dermal irritation/corrosion study according to OECD TG 404 was performed to assess the skin irritation potential of the test substance to the rabbit. Three rabbits received a single four hour, semi-occlusive, dermal administiation of approximately 0.5g of the test substance (moistened with water) and were observed for four days. No dermal reaction was observed in any animal throughout the duration of the study. The means of scores for oedema and erythema at approximately 24, 48 and 72 hours after administration, were 0 for each animal. As a result, the substance is not considered to be irritating to skin.
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