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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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