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Diss Factsheets

Administrative data

Description of key information

The acute median lethal oral dose (LD50) to rats of T-13h is greater than 2000 mg/kg body weight.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
18 August to 27 October 2014
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted under GLP in accordance with an internationally recognised guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Qualifier:
according to guideline
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.1100 (Acute Oral Toxicity)
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.
GLP compliance:
yes (incl. QA statement)
Test type:
acute toxic class method
Limit test:
yes
Species:
rat
Strain:
other: HSD: SD® albino
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: reputable supplier
- Age at study initiation: 8 to 9 weeks
- Weight at study initiation: 164 to 189 g
- Fasting period before study: no
- 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): free access to a standard rodent diet
- Water (e.g. ad libitum): Potable water taken from the public supply was freely available via polycarbonate bottles fitted with sipper tubes
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 23°C
- Humidity (%): 40 to 70%
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): Artificial lighting was controlled to give a cycle of 12 hours continuous light and 12 hours continuous dark per 24 hours.

IN-LIFE DATES: From: To: 7 February to 7 March 2013
Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 200 mg/mL
- Amount of vehicle (if gavage): 10ml/kg body weight
- Justification for choice of vehicle: solubility

MAXIMUM DOSE VOLUME APPLIED: 10mL

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: the dose levels for the study were chosen in compliance with the study guidelines. As no reliable previous toxicological information was available the initial dose level was 300 mg/kg.
Doses:
2000mg/kg body weight
No. of animals per sex per dose:
3
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: clinical - twice daily; bodyweight - Days 1, 8, and 15
- Necropsy of survivors performed: yes


There were no deviations from protocol.
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
There were no deaths during the study.













Clinical signs:
other: There were no clinical signs of reaction to treatment throughout the study.
Gross pathology:
No abnormalities were noted in any animal at the macroscopic examination.
Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute median lethal oral dose (LD50) to rats of T-13h was demonstrated to be between greater than 2000 mg/kg bodyweight.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Additional information

The acute oral toxicity of T-13h was determined by HLS, 2014, Report No.: JNG0005. The study was conducted in accordance with EU method B.1 tris and OECD Guideline 423 and was considered reliable.

Justification for selection of acute toxicity – oral endpoint

A single study is available. It is considered to be adequate and reliable.

Justification for classification or non-classification

There were no deaths or clinical signs of reaction to treatment. All animals achieved satisfactory bodyweight and no abnormalities were noted in any animal during macroscopic examination.

The lack of any adverse effect indicates that the substance is not classified with respect to acute oral toxicity.