Registration Dossier
Registration Dossier
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EC number: 939-042-8 | CAS number: 1482217-03-7
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 18th April 2013 - 8th May 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 402 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1200 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Japanese Ministry of Agriculture, Forestry and Fisheries, Test Data for Registration of Agricultural Chemicals, Acute dermal toxicity (2-1-2), 12 Nousan No 8147, Agricultural Production Bureau, November 24, 2000
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
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 2014
- Storage condition of test material: RT in the dark
- Other:
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Hsd (SD)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: reputable commercial supplier
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 305-317g (males), 190-216g (females)
- Housing: The cages were solid bottomed polycarbonate cages with a stainless steel mesh lid. Each cage contained a quantity of autoclaved wood flake bedding.
- Diet: Standard rodent diet (Rat and Mouse No. 1 Maintenance Diet)
- Water: ad libitum
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-23
- Humidity (%): 40-70
- Photoperiod (hrs dark / hrs light): 12h dark/12h light
IN-LIFE DATES: From: To: 18 April - 08 May 2013
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- other: 1% w/v aqueous methyl cellulose
- Details on dermal exposure:
- TEST SITE
- Area of exposure: dorso-lumbar region
- % coverage: 10%
- Type of wrap if used: porous gauze held in place with a non-irritating dressing, and further covered by a waterproof dressing encircled firmly around the trunk of the animal
REMOVAL OF TEST SUBSTANCE
- Washing (if done): warm water (30 - 40°C)
- Time after start of exposure: 24h
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bwt
- Concentration (if solution): 500 mg/mL
- Constant volume or concentration used: yes
- For solids, paste formed: yes/no
VEHICLE
- Amount(s) applied (volume or weight with unit): 4.0 mL/kg bwt
- Concentration (if solution):1% w/v
- Lot/batch no. (if required): N/a
- Purity:99.9% - Duration of exposure:
- 24 hours
- Doses:
- 1 dose
- No. of animals per sex per dose:
- 5 males/5 females per dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: twice daily observations and weighed on days 1 (prior to dosing), 8 and 15
- Necropsy of survivors performed: yes
- Other examinations performed: macroscopic examination
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: No deaths were noted at any dose level
- Mortality:
- No deaths during the study
- Clinical signs:
- other: No systemic response to treatment in any animal. Very slight erythema was seen in one female on Day 2 to 5, resolving by Day 6. No dermal reactions were observed in any other animal during the study.
- Gross pathology:
- No abnormalities were noted in any animal at the macroscopic examination at study termination on Day 15.
Applicant's summary and conclusion
- Conclusions:
- The acute median lethal dermal dose (LD50) to rats of T-1620L was demonstrated to be greater than 2000 mg/kg bodyweight.
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