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Description of key information

Acute toxicity- ORAL

In an acute oral toxicity study, the acute oral LD50 of the test chemical was determined in 10 rats. The rats were observed for mortality and/or systemic effects for 14 days. Slight lethargy was observed during the course of the study. The LD50 exceeded 5 g/kg based on one (1/10) death at that dose. Thus, based on all the observations and results, it was concluded that the test chemical is not acutely toxic to the rats when administered at 5000 mg/kg bw.

Acute toxicity- Dermal

An acute dermal toxicity study was performed to evaluate the toxic potential of the test chemical in rabbits. Nine rabbits received a single dermal application of neat test chemical at a dose of 5 g/kg. The rabbits were observed for mortality and/or systemic effects for 14 days. No clinical signs or mortality were observed. Thus, based on all the observations and results, it was concluded that the LD50 of the test chemical was observed to be >5000 mg/kg bw.

Acute toxicity- Inhalation

The study doesnot need to be conducted because exposure of humans via inhalation route is not likely taking into account the vapor pressure of the substance and/or the possibility of exposure to aerosols, particles, or droplets of an inhalable size. The test chemical has very low vapor pressure < 0.1333 Pa at 20°C., so the potential for the generation of inhalable vapors is very low. The normal conditions of use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be highly unlikely.

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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
Data is from a peer-reviewed publication.
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Principles of method if other than guideline:
Equivalent or similar to OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
GLP compliance:
not specified
Test type:
acute toxic class method
Limit test:
yes
Species:
rat
Strain:
not specified
Sex:
not specified
Details on test animals or test system and environmental conditions:
No Data Available
Route of administration:
oral: unspecified
Vehicle:
not specified
Details on oral exposure:
single exposure
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
10 rats
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days (or other?) : 14 days
- Frequency of observations and weighing:
- Necropsy of survivors performed: yes/no : no
- Clinical signs including body weight : yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other:
Statistics:
No Data Available
Preliminary study:
No Data Available
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
not determinable due to absence of adverse toxic effects
Mortality:
No mortality due to the administration of the test chemical was observed at the given doses. However, one death was observed.
Clinical signs:
other: Slight lethargy was observed at the administered doses.
Gross pathology:
No Data Available
Other findings:
No Data Available
Interpretation of results:
other: Not Classified
Conclusions:
Slight lethargy was observed during the course of the study. The LD50 exceeded 5 g/kg based on one (1/10) death at that dose. Thus, based on all the observations and results, it was concluded that the test chemical is not acutely toxic to the rats when administered at 5000 mg/kg bw.
Executive summary:

In an acute oral toxicity study, the acute oral LD50 of the test chemical was determined in 10 rats. The rats were observed for mortality and/or systemic effects for 14 days. Slight lethargy was observed during the course of the study. The LD50 exceeded 5 g/kg based on one (1/10) death at that dose. Thus, based on all the observations and results, it was concluded that the test chemical is not acutely toxic to the rats when administered at 5000 mg/kg bw.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
5 000 mg/kg bw
Quality of whole database:
Klimisch Rating 2

Acute toxicity: via inhalation route

Link to relevant study records
Reference
Endpoint:
acute toxicity: inhalation
Data waiving:
exposure considerations
Justification for data waiving:
the study does not need to be conducted because exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size
Clinical signs:
other:
Endpoint conclusion
Endpoint conclusion:
no study available
Quality of whole database:
waiver

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:
data from handbook or collection of data
Justification for type of information:
Data is from a peer reviewed journal.
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Principles of method if other than guideline:
Equivalent or similar to OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
no
Species:
rabbit
Strain:
not specified
Sex:
not specified
Details on test animals or test system and environmental conditions:
No Data Available
Type of coverage:
not specified
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
Nine rabbits received a single dermal application of neat test chemicals at a dose of 5 g/kg.
Duration of exposure:
Single exposure (24 hours)
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
9 rabbits were used in this study.
Control animals:
not required
Details on study design:
No Data Available
Statistics:
No Data Available
Preliminary study:
No Data Available
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality was observed at any given doses.
Clinical signs:
other: No clinical sgns were observed at the tested doses.
Gross pathology:
No Data Available
Other findings:
No Data Available
Interpretation of results:
other: not classified
Conclusions:
No clinical signs or mortality were observed. Thus, based on all the observations and results, it was concluded that the LD50 of the test chemical was observed to be >5000 mg/kg bw.
Executive summary:

An acute dermal toxicity study was performed to evaluate the toxic potential of the test chemical in rabbits.Nine rabbits received a single dermal application of neat test chemical at a dose of 5 g/kg. The rabbits were observed for mortality and/or systemic effects for 14 days. No clinical signs or mortality were observed. Thus, based on all the observations and results, it was concluded that the LD50 of the test chemical was observed to be >5000 mg/kg bw.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
5 000 mg/kg bw
Quality of whole database:
Klimisch Rating 2

Additional information

Acute toxicity- Oral

Various studies have been reviewed to determine the acute oral LD50 of the test chemical. These include in vivo experimental studies performed on rats for the test chemical. The results are mentioned below:

In an acute oral toxicity study, the acute oral LD50 of the test chemical was determined in 10 rats. The rats were observed for mortality and/or systemic effects for 14 days. Slight lethargy was observed during the course of the study. The LD50 exceeded 5 g/kg based on one (1/10) death at that dose. Thus, based on all the observations and results, it was concluded that the test chemical is not acutely toxic to the rats when administered at 5000 mg/kg bw.

This result is supported by an Acute Oral Toxicity Study of the test chemical in Rats, conducted as per OECD No. 423. Six female Wistar rats were selected for acute oral toxicity study. The animals were fasted for minimum 16-18 hours prior to dosing and for 3-4 hours post dosing, with food withheld but drinking water provided ad libitum. The time intervals between dosing were determined by the onset, duration and severity of toxic signs. Three rats of first group were dosed with starting dose of 2000 mg/kg body weight and the animals did not show any mortality so another three animals of the same group were dosed with 2000 mg/kg body weight and no mortality was observed. Hence, further dosing was stopped. Body weights were re­corded on day 0 (prior to dosing) 7 and 14. Body weight gain was observed in all the animals treated with 2000 mg/kg body weight, during the 14 day observation period, as compared to day 0. At 2000 mg/kg, animal nos. 1, 2, 3, 5 and 6 were observed normal throughout the experimental period, whereas animal no. 4 was observed normal at 30 minutes, 1, 2, 3 and 4 hours, with mild ataxia from day 1 to 4, with mild tremors on day 1, with mild chromodacryorrhea from day 2 to 6 and with moderate to mild lethargy from day 3 to 9 post dosing followed by normal observation till day 14. No external and internal gross pathological changes were seen in all the six animals treated with 2000 mg/kg body weight during terminal sacrifice. Based on all the observations and results, the acute oral LD50 (cut-off value) of the test chemical was 5000 mg/kg body weight. Thus, by considering the CLP criteria for acute toxicity rating for the chemicals, it infers that the test chemical does not exhibit acute oral toxicity i.e it is acutely non toxic to animals.

These results are further supported by another acute Oral Toxicity Study of the test chemical conducted as per OECD 423 Guidelines in rats. Six female Wistar rats were selected for acute oral toxicity study. The animals were fasted for minimum 16-18 hours prior to dosing and for 4 hours post dosing, food was withheld but drinking water provided ad libitum. Three rats of first group were dosed with starting dose of 2000 mg/kg body weight and the animals did not show any mortality so another three animals of the same group were dosed with 2000 mg/kg body weight and no mortality was observed. Hence, further dosing was stopped. Body weights were recorded on day 0 (prior to dosing) 7 and 14. Mean body weight of all the animals treated with 2000 mg/kg body weight was observed with gain on day 7 and 14, as compared to day 0. At 2000 mg/kg, all the animals were normal throughout the experimental period. No external and internal gross pathological changes were seen in all the six animals treated with 2000 mg/kg body weight during terminal sacrifice. Under the conditions of this acute oral toxicity study, the acute oral LD50 value was greater than 2000 mg/kg. Hence, the test chemical can be classified under the category "Not Classified" as per CLP Regulation.

Based on the available results, the acute oral LD50 for the test chemical can be considered to be > 2000 mg/kg. Hence, the test chemical can be classified under the category "Not Classified" as per CLP Regulation.

Acute toxicity- Dermal

Various studies have been reviewed to determine the acute dermal LD50 of the test chemical. These include in vivo experimental studies performed on rats, rabbits for the test chemical. The results are mentioned below:

 

An acute dermal toxicity study was performed to evaluate the toxic potential of the test chemical in rabbits. Nine rabbits received a single dermal application of neat test chemical at a dose of 5 g/kg. The rabbits were observed for mortality and/or systemic effects for 14 days. No clinical signs or mortality were observed. Thus, based on all the observations and results, it was concluded that the LD50 of the test chemical was observed to be >5000 mg/kg bw.

This result is supported by an Acute Dermal Toxicity Study was conducted using test chemical as per OECD No.402 in 10 male and female healthy young adult Wistar rats which were randomly selected and used for conducting acute dermal toxicity study at the concentration of 2000 mg/kg bw. Rats free from injury and irritation of skin were selected for the study. 24 hours prior to dermal application of test item, approximately 10% of body surface area of each rat was clipped. A limit dose of 2000 mg/ kg body weight of test item was applied by single dermal application and observed for 14 days after treatment. On test day 0, as such amount of test item, calculated based on density (1.0016) and body weight was applied directly on the intact skin of clipped area of rats; the surgical gauze patch was put on to the intact skin of clipped area. This porous gauze dressing was covered with a non-irritating adhesive tape. The porous gauze dressing was wrapped around the abdomen and anchored with non-irritating adhesive tape. After the 24-hour application period, the dressings were removed and the skin was gently wiped with distilled water. The skin reactions were assessed. The animals were observed daily for mortality and clinical signs, during the acclimatization period. All animals were observed for clinical signs at approximately 1, 2, 3 and 4 hours after treatment on day 0 and once daily during test days 114. Mortality was recorded after application on test day 0 and twice daily during days 1-14 (at least once on the day of sacrifice). Local signs / Skin reactions were observed daily from test days 1-14 (in common with clinical signs). Body weights were re­corded on day 0 (prior to application) and on day 7 and 14. All animals were necropsied and examined macroscopically. No mortality was observed in any animal till the end of the experimental period. No clinical signs and any skin reaction were observed throughout the experimental period in all treated animals. The male and female animals were observed with body weight gain throughout the experiment, except on day 7 male animals were observed with decline in mean body weight gain as compared to day 0. The external and internal gross pathological observation of all terminally sacrificed animals did not show any pathological abnormality. Hence the LD50 was considered to be >2000mg/kg bw, when rats were treated with test chemical by dermal application.

These results are further supported by another acute dermal toxicity study for the test chemical conducted as per OECD No. 402 in Wistar Rats. Five male and five female healthy young adult rats were randomly selected and used for conducting acute dermal toxicity study. Rats free from injury and irritation of skin were selected for the study. Approximately, twenty four hours prior to dermal application of test item, greater than 10% of body surface area of each rat was clipped. A limit dose of 2000 mg/ kg body weight based on the test item density (1.07513) and latest body weight was applied by single dermal application and observed for 14 days after treatment. On test day 0, calculated volume of test item was applied directly on the intact skin of clipped area of rats; the porous gauze dressing was put on to the intact skin of clipped area. This porous gauze dressing was covered with a non-irritating tape. After the 24 -hour application period, the dressings were removed and the skin was gently wiped with distilled water. The skin reactions were assessed. The animals were observed daily for mortality and clinical signs, during the acclimatization period and post dosing till the termination. All animals were observed for clinical signs at approximately 1, 2, 3 and 4 hours after treatment on day 0 and once daily during test days 1 14. Mortality was recorded after application on test day 0 and twice daily during days 1-14 (at least once on the day of sacrifice). Local signs / Skin reactions were observed daily from test days 1-14 (in common with clinical signs). Body weights were recorded on day 0 (prior to application) and on day 7 and 14. All animals were necropsied and examined macroscopically. No mortality was observed in any animal till the end of the experimental period. At 2000 mg/kg, all the animals were observed normal throughout the experimental period. Mean body weight was observed with gain on day 7 and 14 of male and female animals, as compared to day 0. The external and internal gross pathological observation of all terminally sacrificed animals did not show any pathological abnormality. Under the conditions of the study, the acute dermal toxicity dose (LD50) was considered to be >2000 mg/kg bw, when rats were treated with the test chemical by dermal application.

Based on the available results, the acute dermal LD50 for the test chemical can be considered to be > 2000 mg/kg. Hence, the test chemical can be classified under the category "Not Classified" as per CLP Regulation.

Acute toxicity- Inhalation

The study doesnot need to be conducted because exposure of humans via inhalation route is not likely taking into account the vapor pressure of the substance and/or the possibility of exposure to aerosols, particles, or droplets of an inhalable size. The test chemical has very low vapor pressure < 0.1333 Pa at 20°C., so the potential for the generation of inhalable vapors is very low. The normal conditions of use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be highly unlikely.

Justification for classification or non-classification

Based on the available results, the test chemical is not likely to cause toxicity when exposed via oral, dermal or inhalation route. Hence, the test chemical can be classified under the category "Not Classified" as per CLP Regulation.