Registration Dossier

Administrative data

Description of key information

The acute oral median lethal dose (LD50) of TK 12 146 in rats is greater than 5 g/kg body weight.
The acute dermal median lethal dose (LD50) of TK 12 146 in rats is greater than 2.5ml/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:
October 1976
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Similar to OECD 401 study performed pre-GLP.
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
Rats were caged singly and kept in a room maintained at a temperature of 21°C. (^2°). Animals were subjected to 12 hours artificial light and 12 hours darkness in each 24 hour period.
A commercial pelleted diet (Oakes Special Diet with added Vit. E) was fed ad lib. Water was available at all times.
Route of administration:
oral: gavage
Vehicle:
polyethylene glycol
Details on oral exposure:
A 25% w/v solution of the compound in polyethylene glycol was administered as a single dose by gavage to rats which had been fasted for 18 hours, at a rate of 20 ml/kg.
Doses:
5000 mg/kg
No. of animals per sex per dose:
5 males and 5 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: daily for clinical signs and deaths
- Necropsy of survivors performed: yes
Statistics:
no statistics performed
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No deaths occured during the course of the study.
Clinical signs:
No clinical signs were noted during the course of the study.
Body weight:
No data.
Gross pathology:
No changes were noted in organs or tissue at the final necropsy.
Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute oral median lethal dose (LD50) of TK 12 146 in rats is greater than 5 g/kg body weight.
Executive summary:

TK12146 was administered by single oral gavage to 5 male and 5 female rats at a dose level of 5000 mg/kg body weight and an application volume of 20 mL/kg. The animals were fastened for 18 hours.

No death and no clinical signs were noted during the 14-day observation.

The acute oral median lethal dose (LD50) of TK 12 146 in rats is greater than 5 g/kg body weight.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
5 000 mg/kg bw

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:
November 1976
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Similar study to OECD 402, non-GLP. Number of animals treated is not mentioned.
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
Rats were caged singly and kept in a room maintained at a temperature of 21°C. (+.2°). Animals were subjected to 12 hours artificial light and 12 hours darkness in each 24 hour period.
A commercial pelleted diet (Oakes Special Diet with added Uit. E) was fed ad lib. Water was available at all times.
Type of coverage:
not specified
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
The animals were prepared and the compound applied according to the method suggested in Working Document No. 14 of the Pesticides Safety Precautions Scheme, published by the Ministry of Agriculture, Fisheries and Food, Pesticides Branch, Great Uestminster House, Horseferry Road, London, S.W.1.
The compound was applied as supplied at the rate of 2.5ml/kg.
Doses:
2.5 ml/kg
Control animals:
not specified
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2.5 mL/kg bw
Based on:
test mat.
Mortality:
No death occurred during the course of the study.
Clinical signs:
No clinical signs were noted during the course of the study.
Body weight:
no datat
Gross pathology:
No changes in organs or tissues were noted at the end necropsy.
Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
The acute dermal median lethal dose (LD50) of TK 12 146 in rats is greater than 2.5ml/kg. body weight.
Executive summary:

The acute dermal median lethal dose (LD50) of TK 12 146 in rats is greater than 2.5ml/kg. body weight.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 500 mg/kg bw

Additional information

TK12146 was administered by single oral gavage to 5 male and 5 female rats at a dose level of 5000 mg/kg body weight and an application volume of 20 mL/kg. The animals were fastened for 18 hours. No death and no clinical signs were noted during the 14-day observation. The acute oral median lethal dose (LD50) of TK 12 146 in rats is greater than 5 g/kg body weight.

The acute dermal median lethal dose (LD50) of TK 12 146 in rats is greater than 2.5ml/kg. body weight.


Justification for selection of acute toxicity – oral endpoint
Only this study is available

Justification for selection of acute toxicity – dermal endpoint
Only this study is available

Justification for classification or non-classification

Based on the above mentioned results the substance does not need to be classified according to CLP regulation (Regulation EC No.1272/2008) and DSD (Directive 67/548/EEC).