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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:
2013
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

Constituent 1
Chemical structure
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:
Specific details on test material used for the study:
- Appearance: Pale yellow powder
- Storage conditions: Ca. 20C 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.