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Administrative data

Description of key information

Acute oral Toxicity:

LD50 > 2000mg/kg body weight

 

Acute dermal Toxicity:

LD50 >2000mg/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:
4th April 2013 - 2nd May 2013
Reliability:
1 (reliable without restriction)
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
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%
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
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
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
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.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Link to relevant study records
Reference
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
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
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
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
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.
Conclusions:
The acute median lethal dermal dose (LD50) to rats of T-1620L was demonstrated to be greater than 2000 mg/kg bodyweight.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Additional information

Justification for classification or non-classification