Registration Dossier
Registration Dossier
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EC number: 939-042-8 | CAS number: 1482217-03-7
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 4th April 2013 - 2nd May 2013
- Reliability:
- 1 (reliable without restriction)
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 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Japanese Ministry of Agriculture, Forestry and Fisheries, Test Data for Registration of Agricultural Chemicals, Acute oral toxicity (2-1-1), 12 Nousan No 8147, Agricultural Production Bureau, November 24, 2000
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class 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
- Specific details on test material used for the study:
- - Appearance: Pale yellow powder
- Storage conditions: Ca. 20C in the dark
- Batch/lot number: OF1211
- Expiry date: 30th April 2014
- Purity/composition: 99.9%
Test animals
- Species:
- rat
- Strain:
- other: Crl:CD (SD)
- Sex:
- 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: 159 - 176g
- Fasting period before study:
- Housing: solid bottomed polycarbonate cages with a stainless steel mesh lid. Each cage contained a quantity of autoclaved softwood bark-free fibre bedding.
- Diet (e.g. ad libitum): standard rodent diet, Rat and Mouse No. 1 Maintenance Diet
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-23°C
- Humidity (%): 40-70%
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12h dark/ 12h light
IN-LIFE DATES: From: To:04 April to 02 May 2013
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: 1% w/v aqueous methyl cellulose
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 1% w/v
- Amount of vehicle (if gavage): 10 mL/kg
- Purity: 99%
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: As no previous toxicological information the initial dose level was 300 mg/kg - Doses:
- 300 mg/kg and 2000 mg/kg
- No. of animals per sex per dose:
- 3
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: twice daily observations, weighed on days 1 (prior to dosing), 8 and 15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: Macroscopic examination performed
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No deaths during the study
- Clinical signs:
- other: No clinical signs
- Gross pathology:
- Pallor of liver of one animal treated at 300 mg/kg. No abnormalities in any other animal
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute median lethal oral dose (LD50) to rats of T-1620L was demonstrated to be greater than 2000 mg/kg bodyweight.
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