Registration Dossier

Administrative data

Description of key information

Acute oral toxicity

The LD50 of the test substance was determined to be 5700 mg/kg bw.

 

Acute dermal toxicity

In the acute dermal toxicity study the LD50 was determined to be greater than 5000 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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study is not GLP compliant but equivalent to guideline.
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
no
Test type:
standard acute method
Limit test:
no
Species:
rat
Strain:
Wistar
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS

- Weight at study initiation: 200 to 250 g
- Fasting period before study: 16 hours
- Diet: Ad libitum
- Water: Ad libitum

Route of administration:
oral: unspecified
Vehicle:
unchanged (no vehicle)
Doses:
3200, 4000, 5000, 6250 mg/kg bw
No. of animals per sex per dose:
10
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: For mortality at 1 and 6 hours and daily thereafter
- Necropsy of survivors performed: yes
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
5 700 mg/kg bw
Based on:
test mat.
95% CL:
> 4 700 - < 6 700
Mortality:
Dosis - Number of died animals from 10
4000 mg/kg bw ; 2/10
5000 mg/kg bw; 5/10
6250 mg/kg bw; 7/10


Clinical signs:
The rats experienced lethargy and slow respiration.
Interpretation of results:
GHS criteria not met
Conclusions:
The LD50 of the test substance was determined to be 5700 mg/kg bw.
Executive summary:

In the non-GLP compliant but guideline similar acute oral toxicity test with rats the following doses were tested 3200, 4000, 5000, 6250 mg/kg bw. 10 Wistar rats were used per dose.

The animals were observed for 14 days and necropsy of survivors was performed. The rats experienced lethargy and slow respiration. The LD50 of the test substance was determined to be 5700 mg/kg bw.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
5 700 mg/kg bw
Quality of whole database:
The study is not GLP compliant but equivalent to OECD guideline.

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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study is not GLP compliant but equivalent to guideline.
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes
Species:
rabbit
Strain:
New Zealand White
Sex:
not specified
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 1.9 to 2.4 kg
Type of coverage:
occlusive
Duration of exposure:
24 hours
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
10
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 7 days
- Frequency of observations and weighing: Erythema and edema signs: Daily; Weights: pre-and post treatment
- Necropsy of survivors performed: Yes
- Other examinations performed: Clinical signs
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No
Clinical signs:
Yes, signs of dermal irritation were observed.
Body weight:
No significant changes
Gross pathology:
No abnormalities were noted at necropsy.
Interpretation of results:
GHS criteria not met
Conclusions:
In the acute dermal toxicity study the discriminating dose was determined to be > 5000 mg/kg bw.
Executive summary:

In the non- GLP compliant but guideline similar acute dermal toxicity study New Zealand White rabbits were used. A dose of 5000 mg/kg bw was administrated 24 hours to the clipped abraded abdominal skin of ten rabbits.

Following exposure the binders were removed and observations made for mortality and toxic effects for a period of seven days.

No animals died during the course of the study. There was no evidence of toxicity from percutaneous absorption of the test substance. Signs of dermal irritation (erythema and edema) were observed until day 7.

No abnormalities were noted at necropsy.

All animals were essentially normal by the termination of the study. Therefore, the LD50 was determined to be > 5000 mg/kg bw.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
Value:
5 000 mg/kg bw
Quality of whole database:
The study is not GLP compliant but equivalent to OECD guideline.

Additional information

Acute oral toxicity

In the non-GLP compliant but guideline similar acute oral toxicity test with rats the following doses were tested 3200, 4000, 5000, 6250 mg/kg bw. 10 Wistar rats were used per dose.

The animals were observed for 14 days and necropsy of survivors was performed. The rats experienced lethargy and slow respiration. The LD50 of the test substance was determined to be 5700 mg/kg bw.

 

 

Acute dermal toxicity

In the non GLP compliant but guideline similar acute dermal toxicity study New Zealand White rabbits were used. A dose of 5000 mg/kg bw was administrated 24 hours to the clipped abraded abdominal skin of ten rabbits.

Following exposure the binders were removed and observations made for mortality and toxic effects for a period of seven days.

No animals died during the course of the study. There was no evidence of toxicity from percutaneous absorption of the test substance. Signs of dermal irritation (erythema and edema) were observed until day 7.

No abnormalities were noted at necropsy.

All animals were essentially normal by the termination of the study. Therefore, the LD50 was determined to be greater than 5000 mg/kg bw.


Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008 (oral)

Based on the results of the acute oral toxicity LD 50 = 5700 mg/kg bw the substance is not considered to be classified for acute oral toxicity under Regulation (EC) No 1272/2008, as amended for the tenth time in Regulation (EU) No 2017/776.

 

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008 (dermal)

Based on the results of the acute dermal toxicity LD50 > 5000 mg/kg bw the substance is not considered to be classified for acute dermal toxicity under Regulation (EC) No 1272/2008, as amended for the tenth time in Regulation (EU) No 2017/776.