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Registration Dossier
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EC number: 939-042-8 | CAS number: 1482217-03-7
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 8th April 2013- 3rd July 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Japanese Ministry of Agriculture, Forestry and Fisheries, Test Data for Registration of Agricultural Chemicals, Skin Irritation (2-1-4), 12 Nohsan No. 8147, Agricultural Production Bureau, November 24, 2000
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 1,12-bis({2-[4-(4,6-diphenyl-1,3,5-triazin-2-yl)-3-hydroxyphenoxy]ethyl}) dodecanedioate
- EC Number:
- 939-042-8
- Cas Number:
- 1482217-03-7
- Molecular formula:
- C58H56N6O8
- IUPAC Name:
- 1,12-bis({2-[4-(4,6-diphenyl-1,3,5-triazin-2-yl)-3-hydroxyphenoxy]ethyl}) dodecanedioate
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): T-1620L
- Physical state: pale yellow powder
- Analytical purity: 99.9%
- Lot/batch No.: OF1211
- Expiration date of the lot/batch: 30 April 2013
- Storage condition of test material: RT in the dark
- Other:
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: reputable commercial supplier
- Age at study initiation: 33-48 weeks
- Weight at study initiation:3.06 to 4.13 kg
- Housing: housed individually in plastic cages with perforated floors
- Diet (e.g. ad libitum): Each rabbit was offered 125 g of a standard laboratory rabbit diet per day
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 16-28 weeks
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16-20°C
- Humidity (%): 40-70%
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12h dark/ 12h light
IN-LIFE DATES: From: To: 08 April to 03 July 2013
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5g, area wetted with 0.5 mL reverse osmosis water beforehand
- Concentration (if solution): N/a - Duration of treatment / exposure:
- 4-hour exposure
- Observation period:
- 4 days
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: dorso-lumbar region
- % coverage: 100%
- Type of wrap if used: a 2-ply 25 mm x 25 mm porous gauze pad secured with ‘blenderm’ surgical tape
REMOVAL OF TEST SUBSTANCE
- Washing (if done): lukewarm water (30-40°C)
- Time after start of exposure: 4 hours
SCORING SYSTEM: Local dermal irritation was assessed using the prescribed numerical system and a primary irritation index (PTI) calculated from the scores
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 0
- Irritant / corrosive response data:
- There was no sign of toxicity or ill health in any rabbit during the observation period. No dermal reaction was observed in any animal throughout the duration of the study
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The Primary Irritation Index was calculated to be 0.0; T-1620Lwas classified as ‘non-irritant’ according to the criteria of the ECETOC and did not require labelling in accordance with Commission Regulation 1272/2008
- Executive summary:
The Primary Irritation Index was calculated to be 0.0; T-1620Lwas classified as ‘non-irritant’ according to the criteria of the ECETOC and did not require labelling in accordance with Commission Regulation 1272/2008
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