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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

oral, rats, LD50 > 8587 mg/kg

dermal, rats, LD50 (LD0) > 5000 mg/kg

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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study following official guideline not GLP compliant
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Limit test:
no
Species:
rat
Strain:
Wistar
Sex:
male
Details on test animals or test system and environmental conditions:
Source: Breeding Farm VELAZ
Sex: male
Animal body weight: range 130-170 g
Acclimtisation: minimum 5 days
Total number: 6 males for orientatio study
10 males per dose group for mian study
Housing: animal room with monitored conditions 3-5 animals in one plastic cage Velaz T4
Diet: standard pelleted diet VELAZ
Water: drinking tap water ad libitum
Microclimatic conditions: room temperature 22+/-3°C permanently monitored
relative humidity 30-70% permanently monitored
light: 12 hours light/12 hours dark
Bedding: sterilized shaving of soft wood
Randomisation: according to the internal rule, at the start of the study the weight variation of animals was minimal and did not exceed +/-20% of the mean weight for each sex
Identification of animals: colour marks 1-3 in orientation study and 1-5 in main study on tail of animals, each cage was marked with the number of study, sex and dose of the test item
Health conditions: certificate of good health conditions-from breeding farm; no signs of diseases were observed at clinical check-in, during the acclimatisation period and before the start of study
Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
Immediately before application the test item was weighed, mixed in vehicle ( water for injection) and resulting suspension was administered to the stomach by tube.
Doses:
5020, 6310 and 7943 mg/kg bw for the main study
in the orientation study the following doses were used: 10000 mg/kg and 5000 mg/kg
No. of animals per sex per dose:
10 males per dose for the main study
3 males per dose for the orientation study
Control animals:
no
Details on study design:
PREPARATION OF EXPERIMENTAL ANIMALS
About 20h before the oral administration the animals were not fed, water was given ad libitum.
Immediately before application the animals were weighed and distributed to groups with 3 animals to orientation part of the study and group of 10 aniamls for the main study.
The animals were fed 3 hours after application of the test item

BODY WEIGHT RECORDING
Animals were weighed before application and at day 15, before euthanasia of animals. Average body weight within a group was calculated from individual body weigths. Body weight increments were calculated from body weight at the start of the study and at the end of the study.

CLINICAL EXAMINATIONS
After application the animals were observed individually
1st day: at 30min and at 3h
2nd day: in the morning and in the afternoon
up to 14th day: once daily
Observations included: changes in the skin and fur, eyes, visible mucous membranes, behaviour of animals, somatomotor activity, reactions to stimuli, presence of lacrimation, salivation and discharge from nostrils, function of respiratory, digestive and urogenital system.

PATHOLOGICAL EXAMINATION
All the test animals that survived to the end of the study were sacrificed on the 15th day and gross necroscopy was performed. Nutritious status, body surface, body foramina, thoracic, abdominal and cranial cavity were evaluated.
Sex:
male
Dose descriptor:
LD50
Effect level:
6 857 mg/kg bw
Based on:
test mat.
Mortality:
Death of animals occured in all dose groups

dose: 5020 mg/kg bw, 1 male died at day 1
dose: 6310 mg/kg bw, 2 males died at day 1
dose: 7943 mg/kg bw, 3 males died after 3 hours, 7 males died at day 1
Clinical signs:
other: The test item caused diarrhoea and faintness in the period up to 3 hour after administration. After 24hours after application the diarrhoea receded. Other finding during clinical observations were normal.
Gross pathology:
The test item caused colouration of organs while other patho-morfological signs were not found.
Interpretation of results:
other: not classified under Regulation 1272/2008
Conclusions:
The substance was tested for acute toxicity oral following OECD 401. The LD50 was found to be equal to 6857 mg/kw bw.
Executive summary:

The substance was tested for acute toxicity oral following OECD 401. The LD50 was found to be equal to 6857 mg/kw bw.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study following official guideline not GLP compliant
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
no
Limit test:
yes
Species:
rat
Strain:
Wistar
Sex:
male
Details on test animals or test system and environmental conditions:
Source: breeding farm VELAZ
Sex: males
Acclimatisation: minimum 5 days
Total number: 5
Housing: animal room with monitored conditions-5 animals in one plastic breeding cage Velaz T4
Diet: standard pelleted diet
Water: drinking tap water ad libitum
Microclimatic conditions: room temperature 22 +/- 3°C permanently monitored
relative humidity 30-70% permanently monitored
light: 12 hours light/12 hours dark
Bedding: sterilized shavings of soft wood
Randomisation: according to the internal rule, at the start of the study the weight variation of animals was minimal and did not exceed +/- 20% fi the mean weight for each sex
Identification of animals: colour marks 1-5 on tail of animals, each cage was marked with the number of study, sex and dose of the test substance
Health conditions: certificate of good health condition-from breeding farm; no signs of diseases were observed at clinical check-in, during the acclimatisation period and before the strat of study
Type of coverage:
occlusive
Vehicle:
other: moistened with water pro-injection
Details on dermal exposure:
The amount of the test substance for each animal was weighed 8according to its body weight) and moistened with water for injection immediately before application.
Aproximately 24h before application the fur on the back of animals was shaved at area about 6x6 cm. Aliquot part of the test substance was applied on the depilated area of skin. The application site was covered by mull, plastic foil and held in contact by plaster (strapping). After 24h the occlusive dressing and the remains of test substance were removed.
Duration of exposure:
24h
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
5 males
Control animals:
no
Details on study design:
BODY WEIGHT RECORDING
Animlas were weighed before application, at day 8 and before euthanasia of animals. Average body weight in a group was calculated from individual weights.

CLINICAL EXAMINATIONS
After application the animals were observed individually
1st day: at 30 min and 3h
2nd day: in the morning and in the afternoon
up to 14th day: once daily
Observations included: changes in the skin and fur, eyes, visible mucous membranes, behaviour of animals, somatomotor activity, reactions to stimuli, presence of lacrimation, salivation and discharge from nostrils, function of respiratory, digestive and urogenital system.

PATHOLOGICAL EXAMINATION
All the test animals that survived to the end of the study were sacrificed on the 15th day and gross necroscopy was performed. Nutritious status, body surface, body foramina, thoracic, abdominal and cranial cavity were evaluated.
Sex:
male
Dose descriptor:
LD50
Effect level:
5 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality
Clinical signs:
other: No clinical signs
Gross pathology:
All animals were without patho-morfological signs
Interpretation of results:
other: not classified under Regulation 1272/2008
Conclusions:
The substance was tested for acute toxicity dermal, in a limit test, following OECD 402. The LD50 (LD0) was found to be equal to 5000 mg/kg bw
Executive summary:

The substance was tested for acute toxicity dermal, in a limit test, following OECD 402. The LD50 (LD0) was found to be equal to 5000 mg/kg bw

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Additional information

Justification for classification or non-classification

According to the CLP Regulation (EC n. 1272/2008), table 3.1.1, Acute toxicity hazard categories and acute toxicity estimates (ATE) defining the respective categories:

For Acute toxicity oral route:

Category 1: ATE <= 5 mg/kg bw

Category 2: 5 < ATE <= 50 mg/kg bw

Category 3: 50 < ATE <= 300 mg/kg bw

Category 4: 300 < ATE <= 2000 mg/kg bw

The LD50 of the test substance was determined to be 6857 mg/kg bw in the chosen reference test, which is outside the above criteria. Therefore, the test substance is not classified for Acute toxicity by oral exposure.

 

According to the CLP Regulation (EC n. 1272/2008), table 3.1.1, Acute toxicity hazard categories and acute toxicity estimates (ATE) defining the respective categories:

For Acute toxicity dermal route:

Category 1: ATE <= 50 mg/kg bw

Category 2: 50 < ATE <= 200 mg/kg bw

Category 3: 200 < ATE <= 1000 mg/kg bw

Category 4: 1000 < ATE <= 2000 mg/kg bw

The LD50 of the test substance was determined to be more than 5000 mg/kg bw in the chosen reference test, which is outside the above criteria. Therefore, the test substance is not classified for Acute toxicity by dermal exposure.