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Description of key information

The acute toxicity of Aradur 1019 via oral and dermal routes have been determined. Both studies were carried out before published methods, such as OECD guidelines, were available. The methodology used is equivalent to the current guidelines in all cases.

The results are reported:

Acute oral LD50 2284 mg/kg bw

Acute dermal LD50 >4500 mg/kg bw

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 1977
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
no
Species:
rat
Sex:
male/female
Details on test animals or test system and environmental conditions:
Healthy random bred rats of the Tif: RAIf (SPF) strain raised on our premises were used for these experiments. They were kept at a room temperature of 22 + 1° C, at a relative humidity of 55 + 5 % and on a 10 hours light cycle day. They received ad libitum rat food - NAFAG, Gossau SG - and water. Prior to treatment the animals were adapted to our laboratories for a minimum of 4 days and the initial body weight ranged from 160 to 180 grams.
Route of administration:
oral: gavage
Vehicle:
polyethylene glycol
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 10, 20, 30, 50% of formulation

Doses:
1000, 2150, 2780, 3170, 3590 and 4640 mg/kg
No. of animals per sex per dose:
5
Control animals:
not specified
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 2 284 mg/kg bw
95% CL:
>= 2 026 - <= 2 576
Mortality:
Deaths occured after 24 hours at 2150 mg/kg dosage. 100% mortality was seen at 4649 mg/kg after 24 hours
Clinical signs:
Within 2 hours after treatment the rats in all dosage groups showed sedation, dyspnoea, exophthalmos, curved position and ruffled fur. Sedation became more accentuated as the dose was increased. The surviving animals recovered within 8 to 9 days.
Body weight:
Not recorded
Gross pathology:
No substance related gross organ changes were seen
Interpretation of results:
Category 5 based on GHS criteria
Conclusions:
The acute oral LD50 of TK 12271 in rats of both sexes observed over a period of 14 days is 2284 (2026-2576) mg/kg. The test material has therefore a slight acute toxicity to the rat by this route of administration.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 284 mg/kg bw

Acute toxicity: via dermal route

Link to relevant study records

Referenceopen allclose all

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
November 1979
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Qualifier:
according to guideline
Guideline:
other: A method for determining the dermal toxicity of pesticides. British Journal of Industrial Medicine, Vol 26, page 59-64, 1969
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
no
Specific details on test material used for the study:
Batch number Sdg. 807701
Species:
rabbit
Strain:
other: Tvanovas, 7964 Kisslegg/Allggsu
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2 to 3 kg
- Housing: Wire cages, 10 hours a day light cycle
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: minimum of 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2°C
- Humidity (%): 55 +/- 10%
- Photoperiod (hrs dark / hrs light): 14 hrs dark / 10 hrs light

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Type of wrap if used: Adhesive, elastic

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Washed with lukewarm water
- Time after start of exposure: 24 hours after treatment

TEST MATERIAL
- Concentration (if solution): 1, 2, 4 and 6 ml/kg body weight

Duration of exposure:
24 hours
Doses:
1, 2, 4 and 6 ml/kg body weight
1000, 2000, 4000 and 6000 mg/kg
No. of animals per sex per dose:
3
Control animals:
yes, concurrent no treatment
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Day 1, 7 and 14
- Necropsy of survivors performed: yes/no Yes
- Other examinations performed: Sedation, dyspnoea, dacryorrhoea, chromydacryorrhoea, rinorrhea, epistaxis, salivations, ruffled fur, pallor, cyanosis, diarrhoea, body position (ventral), body position (lateral), body position (curved), ataxia, tirmus, tremor, tonic cllonic muscle spasms, convulsions.
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 4 500 mg/kg bw
Based on:
test mat.
Mortality:
100% at top dose (6000 mg/kg)
Clinical signs:
After 24 hours all animals at doses 1000 and 2000 mg/kg showed signs of sedation, ruffled fur and had a curved body position. They recovered from sedation after 11 days, ruffled fur after 8 days and curved body position after 5 days.
At the 4000 mg/kg dose level the same symptoms were seen at 2 hours, along with ataxia and tremor at day 2, which were gone on day4.
Body weight:
Body weight remained consistent throughout the study
Gross pathology:
No substance related gross organ changes were seen.
Other findings:
The material was shown to cause severe skin irritation
Interpretation of results:
Category 5 based on GHS criteria
Conclusions:
The acute dermal LD50 of TK 12271 in rabbits of both sexes observed over a period of 14 days is approximately 4 500 mg/kg. The test material has therefore a slight acute toxicity to the rabbit by this route of application.*
Severe skin irritation did occur.
Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
September 1977
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
no
Species:
rat
Sex:
male/female
Details on dermal exposure:
Healthy random bred rats of the Tif: RAIf (SPF) strain raised on our premises were used for these experiments. They were kept at a room temperature of 22 + 1° C, at a relative humidity of 55 + 5 % and on a 10 hours light cycle day. They received ad libitum rat food - NAFAG, Gossau SG - and water. Prior to treatment the animals were adapted to our laboratories for a minimum of 4 days and the initial body weight ranged from 180 to 200 grams.
Duration of exposure:
24 hours
Doses:
3590 and 4640 mg/kg
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: No weights were recorded
- Necropsy of survivors performed: yes
- Other examinations performed: Within 24 hours after treatment the rats in all dosage groups showed dyspnoea, exophthalmQs, curved position and ruffled fur. No local skin irritation was seen. The animals recovered from systemic symptoms within 11 to 13 days.
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 4 600 mg/kg bw
Based on:
test mat.
Mortality:
No substance related mortaility was observed
Clinical signs:
Within 24 hours after treatment the rats in all dosage groups showed dyspnoea, exophthalmQs, curved position and ruffled fur. No local skin irritation was seen. The animals recovered from systemic symptoms within 11 to 13 days.
Body weight:
Not recorded
Gross pathology:
No substance related gross organ changes were seen
Interpretation of results:
Category 5 based on GHS criteria
Conclusions:
The acute dermal LD50 of TK 12271 in rats of both sexes observed over a period of 14 days is greater than 4600 mg/kg, The test material has therefore practically no acute toxicity to the rat by this route of administration.
Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
November 1979
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
no
Specific details on test material used for the study:
Batch no. : Sdg. 807701
Species:
rat
Sex:
male/female
Details on test animals or test system and environmental conditions:
Healthy random bred rats of the Tif: RAIf (SPF) strain (8 to 9 weeks old) raised on the premises were used for these experiments. They were kept at a room temperature of 22 + 2° C, at a relative humidity of 55 + 10 % and on a 10 hours light cycle day. They received ad libitum rat food - NAFAG, Gossau SG - and water. Prior to treatment the animals were adapted to our laboratories for a minimum of 4 days.
Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
During the treatment and observation period the rats were housed individually in Macroion cages (type 2). Approximately 24 hours before treatment an area on the back of the rats of approximately 60 square cm was shaved with an electric clipper. For treatment the test material was evenly dispersed on the skin with a syringe and was covered with an occlusive dressing which was fastened around the trunk with an adhesive elastic bandage. After 24 hours the dressing was removed, the skin was cleaned with lukewarm water and the reaction of the skin was appraised
Duration of exposure:
24 hours
Doses:
2000, 3000 and 4000 mg/kg
No. of animals per sex per dose:
5
Control animals:
yes, concurrent no treatment
Details on study design:
Logit model
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 4 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality was observed
Clinical signs:
The animals recovered from systemic symptoms within 7 to 8 days. They were submitted to a necropsy at the end of the observation period.
Body weight:
Body weights remained consistent throughout
Gross pathology:
No substance related gross organ changes were seen.
Interpretation of results:
Category 5 based on GHS criteria
Conclusions:
The acute dermal LD50 of TK 12271 in rats of both sexes observed over a period of 14 days is greater than 4000 mg/kg, The test material has therefore practically no acute toxicity to the rat by this route of application. *Skin irritation did occur.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
4 500 mg/kg bw

Additional information

Justification for classification or non-classification

Results for acute oral and dermal toxicity give LD50 results that are above the upper limit for classification according to CLP. However, according to GHS it would be assessed for classification as category 5.