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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Acute oral toxicity: 

The acute oral toxicity dose (LD50) was considered based on different studies conducted on rats for the test chemical. The LD50 value is >2000 mg/kg bw, for acute oral toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute oral toxicity.

Acute Inhalation Toxicity:

The acute inhalation toxicity study need not be conducted because exposure to humans via inhalation route is not likely taking into account due to the low vapour pressure of the test chemical; also it has a particle size distribution of 53-150 micron, so the potential for the generation of inhalable vapours is very low. Also 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 and therefore this study is considered for waiver. 

Acute Dermal toxicity:

The acute dermal toxicity dose (LD50) was considered based on different studies conducted on rats and rabbits for the test chemical. The studies concluded that LD50 value is >2000 mg/kg bw, for acute dermal toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute dermal toxicity.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Remarks:
experimental data from various test chemicals
Justification for type of information:
Data is summarized based on the available information from various test chemicals.
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across source
Qualifier:
according to guideline
Guideline:
other: As mentioned below
Principles of method if other than guideline:
WoE report is based on 3 acute oral toxicity studies as - WoE 2, WoE 3 and WoE 4.
Acute Oral toxicity test was carried out to study the effects of the test chemicals on rodents.
GLP compliance:
not specified
Test type:
other: not specified
Limit test:
no
Species:
rat
Strain:
other: 1. not specified 2. Crj: CD (SD) (SPF) 3. Fischer 344
Sex:
male/female
Details on test animals or test system and environmental conditions:
1. not specified
2. Details on test animal
TEST ANIMALS
- Source: Charles River Japan Co., Ltd. (Kanagawa)
- Age at study initiation: Four weeks old
- Fasting period before study: 16 hours
- Housing: Animals were housed in stainless mesh breeding cages with 5 animals in a breeding room.
- Diet (e.g. ad libitum): solid feed MF was provided ad libitum
- Water (e.g. ad libitum): tap water was provided ad libitum
- Acclimation period: The animals were acclimatized to the test environment after inspection, and administered at 6 weeks of age.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23.2 to 24.4 ° C.
- Humidity (%):50 to 64%
- Photoperiod (hrs dark / hrs light): 12 hours (7 am lights, 7 pm off)
3. Details on test animal
TEST ANIMALS
- Source: Charles River Japan, Inc. (Kanagawa, Japan)
- Age at study initiation: 5-wk-old
- Diet (e.g. ad libitum): basal diet was provided until study started
- Water (e.g. ad libitum): tap-water was provided until study started
Route of administration:
other: 1. oral: unspecified 2. oral: gavage 3. oral: gavage
Vehicle:
other: 1. not specified 2. distilled water 3. Distilled water
Details on oral exposure:
1. not specified
2. Details on exposure
VEHICLE
- Concentration in vehicle:2000 mg/kg bw
- Amount of vehicle (if gavage): 1 mL per 100 g body weight
- Justification for choice of vehicle:the test substance was soluble in distilled water to a concentration of 200 mg / mL.

DOSAGE PREPARATION (if unusual): The test substance was dissolved in distilled water to a concentration of 200 mg / mL. Preparation of the administration solution was done at the time of use.The concentration of the test substance in the administration solution (total concentration: n = 3) was measured promptly after preparation, and it was confirmed that it was properly prepared and the dose was calculated based on the body weight measured for each individual.
3. not specified
Doses:
1. 1200 mg/kg bw
2. 0 and 2000 mg/kg bw
3. 500, 1000, 2000, 4000 and 8000 mg/kg bw
No. of animals per sex per dose:
1. not specified
2. Total: 28 animals (14 male and 14 female)
3. not specified
Control animals:
other: 1. not specified 2. yes 3. not specified
Details on study design:
1. not specified
2. - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations of poisoning symptoms and survival and death were made every hour for 6 hours after administration and twice a day for 14 days from the day after administration.
- Body Weight : All animals were weighed immediately before administration, 7 and 14 days after administration.
- Pathology examination: At the end of the observation, all animals were anesthetized with ether, euthanized by euthanasia, dissected, and gross pathological findings were recorded.
- Other examinations performed: clinical signs, body weight.
3. Details on study design
- Duration of observation period following administration: 10 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs
Statistics:
1. not specified
2. not specified
3. not specified
Preliminary study:
1. not specified
2. In preliminary tests conducted prior to this study no deaths were observed in any of the 500, 1000 and 2000 mg / kg groups. Therefore, the dose of this study was one dose of 2000 mg / kg which is specified as the upper limit dose in OECD guidelines "acute oral" in both sexes, and a vehicle control group was also set in each sex.
3. not specified
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 1 200 mg/kg bw
Based on:
test mat.
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: no mortality was observed
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 8 000 mg/kg bw
Based on:
test mat.
Mortality:
1. No mortality was observed in animals at 1200 mg/kg bw.
2. No mortality was observed at dose 2000 mg/kg bw
3. one female rat given 8000 mg/kg died at wk 1, all of the other rats survived until the end of the study (10 days).
Clinical signs:
other: 1. not specified 2. No abnormalities were observed in the general condition in any animal throughout the observation period. 3. The general condition of the animals was a decrease in spontaneous activity. The rats recovered from this symptom in a few days
Gross pathology:
1. not specified
2. No abnormalities were found in any animals at the time of the end of the observation period.
3. No clear toxicological effect was observed in rats that died or were killed, except for haemorrhage of the lung which was observed in some rats given the highest dose.
Other findings:
1. not specified
2. not specified
3. not specified
Interpretation of results:
other: Not classified
Conclusions:
According to CLP regulation, the test chemical cannot be classified for acute oral toxicity, as the LD50 value is >2000 mg/kg bw.
Executive summary:

In different studies, the given test chemical has been investigated for acute oral toxicity to a greater or lesser extent. Often are the studies based on in-vivo experiments in rodents,

i.e. most commonly in rats for test chemical. The studies are summarized as below –

 

The study was mentioned in handbook and secondary report and conducted in rats to determine acute oral toxicity dose for the given test chemical at the dose concentration of 1200 mg/kg bw. Animals were observed for mortality. No mortality was observed in animals treated at 1200 mg/kg bw. Therefore, the LD50 value was considered to be >1200 mg/kg bw, when rats were treated with the given test chemical via oral route. As the details of the study (Number of animals, dose ranges, time/number of death, clinical signs, etc.) not mentioned, the given test chemical is not classified for acute oral toxicity.

 

The above study is supported with another study mentioned in authoritative database to determine the acute oral toxicity profile of the given test chemical as per OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method) in male and female Crj: CD (SD) rats (SPF) at the dose concentration of 0 and 2000 mg/kg bw.

In preliminary tests conducted prior to this study, no deaths were observed in any of the 500, 1000 and 2000 mg/kg groups. Therefore, the dose of this study was one dose of 2000 mg/kg which is specified as the upper limit dose in OECD guidelines in both sexes, and a vehicle control group was also set in each sex.

For this study, the test substance was dissolved in distilled water to a concentration of 200 mg/mL. Preparation of the administration solution was done at the time of use. The concentration of the test substance in the administration solution (total concentration: n = 3) was measured promptly after preparation, and it was confirmed that it was properly prepared and the dose was calculated based on the body weight measured for each individual. Control animals received distilled water only.

Observations of poisoning symptoms and survival and death were made every hour for 6 hours after administration and twice a day for 14 days from the day after administration. All animals were weighed immediately before administration, 7 and 14 days after administration. At the end of the observation, all animals were anesthetized with ether, euthanized by euthanasia, dissected, and gross pathological findings were recorded.

No mortality was observed at dose 2000 mg/kg bw. No abnormalities were observed in the general condition in any animal throughout the observation period. Body weights of all animals were increased compared to the previous measurements on measurements 7 and 14 days after administration. No abnormalities were found in any animals at the time of the end of the observation period.

Therefore, the lethal concentration (LD50) value for acute oral toxicity test was considered to be >2000 mg/kg bw, when male and female Crj: CD (SD) rats (SPF) were treated with the given test chemical orally via gavage according to OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method).

 

Both the above studies are further supported with the study mentioned in publication and database for the test chemical. The acute oral toxicity study was performed in 4 male and female specified-pathogen-free Fischer (F344) rats using the given test chemical at dose level 500, 1000, 2000, 4000 and 8000 mg/kg bw.

The test chemical was dissolved in distilled water. The rats were observed for 10 days, and the clinical signs and mortality were recorded.

One female rat given 8000 mg/kg died at week 1, all of the other rats survived until the end of the study (10 days). No clear toxicological effect was observed in rats that died or were killed, except for haemorrhage of the lung which was observed in some rats given the highest dose. In Clinical signs observations, decrease in spontaneous activity was seen which was recovered in few days.

Hence, the lethal concentration (LD50) value for acute oral toxicity test was considered to be >8000 mg/kg bw, when 4 male and female specified-pathogen-free Fischer (F344) rats were treated with the given test chemical orally via gavage.

 

Thus, based on the above summarised studies on test chemical, it can be concluded that LD50 value is >2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute oral toxicity.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw
Quality of whole database:
Data is Klimisch 2 and from database.

Acute toxicity: via inhalation route

Link to relevant study records
Reference
Endpoint:
acute toxicity: inhalation
Data waiving:
other justification
Justification for data waiving:
other:
Endpoint conclusion
Quality of whole database:
Waiver

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Remarks:
experimental data from various test chemicals
Justification for type of information:
Data is summarized based on the available information from various test chemicals.
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across source
Qualifier:
according to guideline
Guideline:
other: As mentioned below
Principles of method if other than guideline:
WoE report is based on 3 acute dermal toxicity studies as- WoE 2, WoE 3 and WoE 4.
Acute dermal toxicity test was carried out to study the effects of the test chemicals on rodents.
GLP compliance:
not specified
Test type:
other: not specified
Limit test:
no
Species:
other: 1. rat 2. rat 3. rabbit
Strain:
not specified
Sex:
male/female
Details on test animals or test system and environmental conditions:
1. not specified
2. not specified
3. not specified
Type of coverage:
other: 1. Dermal 2. Dermal 3. dermal
Vehicle:
other: 1. not specified 2. not specified 3. 50% aqueous solution
Details on dermal exposure:
1. not specified
2. not specified
3. not specified
Duration of exposure:
1. not specified
2. not specified
3. not specified
Doses:
1. 2000 mg/kg bw
2. 4000 mg/kg bw
3. 10000 mg/kg bw
No. of animals per sex per dose:
1. not specified
2. not specified
3. 1 rabbit / group
Control animals:
not specified
Details on study design:
1. not specified
2. - Other examinations performed: Animals were observed for mortality and clinical signs changes.
3. not specified
Statistics:
1. not specified
2. not specified
3. not specified
Preliminary study:
1. not specified
2. not specified
3. not specified
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 4 000 mg/kg bw
Based on:
test mat.
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 10 000 mg/kg bw
Based on:
test mat.
Mortality:
1. No mortality was observed in animals at 2000 mg/kg bw.
2. No mortality was observed in animals at 4000 mg/kg bw.
3. No mortality was observed at dose 10000 mg/kg bw
Clinical signs:
other: 1. not specified 2. Changes were observed in kidney, ureter, and bladder and also in liver. 3. not specified
Gross pathology:
1. not specified
2. not specified
3. not specified
Other findings:
1. not specified
2. not specified
3. not specified
Interpretation of results:
other: Not classified
Conclusions:
According to CLP regulation, the test chemical cannot be classified for acute dermal toxicity, as the LD50 value is >2000 mg/kg bw.
Executive summary:

In different studies, the given test chemical has been investigated for acute dermal toxicity to a greater or lesser extent. Often are the studies based on in-vivo experiments in rodents, i.e. most commonly in rats and rabbits for test chemical. The studies are summarized as below –

 

The study was mentioned in authoritative database and secondary source to determine the acute dermal toxicity dose for the given test chemical as per OECD Guideline 402 (Acute Dermal Toxicity) and conducted in rats at the dose concentration of 2000 mg/kg bw. Animals were observed for mortality. No mortality was observed in animals at 2000 mg/kg bw. Therefore, the LD50 value was considered to be >2000 mg/kg bw, when rats were treated with the given test chemical by dermal application.

 

The above study is supported with another study mentioned in authoritative database and conducted on rats at the dose concentration of 4000 mg/kg bw for the given test chemical. Animals were observed for mortality and clinical signs changes. No mortality was observed in animals at 4000 mg/kg bw. Changes were observed in kidney, ureter, and bladder and also in liver. Therefore, the LD50 value was considered to be >4000 mg/kg bw, when rats were treated with the given test chemical by dermal application.

 

Both the above studies are further supported with the study mentioned in publication. In an acute dermal toxicity study, male and female rabbits were treated with test chemical at the dose concentration of 10000 mg/kg bw by dermal application. Animals were observed for mortality. No mortality was observed in treated rabbits at dose 10000 mg/kg bw. Therefore, the LD50 value was considered to be >10000 mg/kg bw, when rats were treated with test chemical by dermal application.  

 

Thus, based on the above summarised studies on test chemical, it can be concluded that LD50 value is >2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute dermal toxicity.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw
Quality of whole database:
Data is Klimisch 2 and from database.

Additional information

Acute oral toxicity:

In different studies, the given test chemical has been investigated for acute oral toxicity to a greater or lesser extent. Often are the studies based on in-vivo experiments in rodents, i.e. most commonly in rats for test chemical. The studies are summarized as below –

 

The study was mentioned in handbook and secondary report and conducted in rats to determine acute oral toxicity dose for the given test chemical at the dose concentration of 1200 mg/kg bw. Animals were observed for mortality. No mortality was observed in animals treated at 1200 mg/kg bw. Therefore, the LD50 value was considered to be >1200 mg/kg bw, when rats were treated with the given test chemical via oral route. As the details of the study (Number of animals, dose ranges, time/number of death, clinical signs, etc.) not mentioned, the given test chemical is not classified for acute oral toxicity.

 

The above study is supported with another study mentioned in authoritative database to determine the acute oral toxicity profile of the given test chemical as per OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method) in male and female Crj: CD (SD) rats (SPF) at the dose concentration of 0 and 2000 mg/kg bw.

In preliminary tests conducted prior to this study, no deaths were observed in any of the 500, 1000 and 2000 mg/kg groups. Therefore, the dose of this study was one dose of 2000 mg/kg which is specified as the upper limit dose in OECD guidelines in both sexes, and a vehicle control group was also set in each sex.

For this study, the test substance was dissolved in distilled water to a concentration of 200 mg/mL. Preparation of the administration solution was done at the time of use. The concentration of the test substance in the administration solution (total concentration: n = 3) was measured promptly after preparation, and it was confirmed that it was properly prepared and the dose was calculated based on the body weight measured for each individual. Control animals received distilled water only.

Observations of poisoning symptoms and survival and death were made every hour for 6 hours after administration and twice a day for 14 days from the day after administration. All animals were weighed immediately before administration, 7 and 14 days after administration. At the end of the observation, all animals were anesthetized with ether, euthanized by euthanasia, dissected, and gross pathological findings were recorded.

No mortality was observed at dose 2000 mg/kg bw. No abnormalities were observed in the general condition in any animal throughout the observation period. Body weights of all animals were increased compared to the previous measurements on measurements 7 and 14 days after administration. No abnormalities were found in any animals at the time of the end of the observation period.

Therefore, the lethal concentration (LD50) value for acute oral toxicity test was considered to be >2000 mg/kg bw, when male and female Crj: CD (SD) rats (SPF) were treated with the given test chemical orally via gavage according to OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method).

 

Both the above studies are further supported with the study mentioned in publication and database for the test chemical. The acute oral toxicity study was performed in 4 male and female specified-pathogen-free Fischer (F344) rats using the given test chemical at dose level 500, 1000, 2000, 4000 and 8000 mg/kg bw.

The test chemical was dissolved in distilled water. The rats were observed for 10 days, and the clinical signs and mortality were recorded.

One female rat given 8000 mg/kg died at week 1, all of the other rats survived until the end of the study (10 days). No clear toxicological effect was observed in rats that died or were killed, except for haemorrhage of the lung which was observed in some rats given the highest dose. In Clinical signs observations, decrease in spontaneous activity was seen which was recovered in few days.

Hence, the lethal concentration (LD50) value for acute oral toxicity test was considered to be >8000 mg/kg bw, when 4 male and female specified-pathogen-free Fischer (F344) rats were treated with the given test chemical orally via gavage.

 

Thus, based on the above summarised studies on test chemical, it can be concluded that LD50 value is >2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute oral toxicity.

 

Acute Inhalation Toxicity:

The acute inhalation toxicity study need not be conducted because exposure to humans via inhalation route is not likely taking into account due to the low vapour pressure of the test chemical; also it has a particle size distribution of 53-150 micron, so the potential for the generation of inhalable vapours is very low. Also 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 and therefore this study is considered for waiver. 

Acute Dermal Toxicity:

In different studies, the given test chemical has been investigated for acute dermal toxicity to a greater or lesser extent. Often are the studies based on in-vivo experiments in rodents, i.e. most commonly in rats and rabbits for test chemical. The studies are summarized as below –

 

The study was mentioned in authoritative database and secondary source to determine the acute dermal toxicity dose for the given test chemical as per OECD Guideline 402 (Acute Dermal Toxicity) and conducted in rats at the dose concentration of 2000 mg/kg bw. Animals were observed for mortality. No mortality was observed in animals at 2000 mg/kg bw. Therefore, the LD50 value was considered to be >2000 mg/kg bw, when rats were treated with the given test chemical by dermal application.

 

The above study is supported with another study mentioned in authoritative database and conducted on rats at the dose concentration of 4000 mg/kg bw for the given test chemical. Animals were observed for mortality and clinical signs changes. No mortality was observed in animals at 4000 mg/kg bw. Changes were observed in kidney, ureter, and bladder and also in liver. Therefore, the LD50 value was considered to be >4000 mg/kg bw, when rats were treated with the given test chemical by dermal application.

 

Both the above studies are further supported with the study mentioned in publication. In an acute dermal toxicity study, male and female rabbits were treated with test chemical at the dose concentration of 10000 mg/kg bw by dermal application. Animals were observed for mortality. No mortality was observed in treated rabbits at dose 10000 mg/kg bw. Therefore, the LD50 value was considered to be >10000 mg/kg bw, when rats were treated with test chemical by dermal application.  

 

Thus, based on the above summarised studies on test chemical, it can be concluded that LD50 value is >2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute dermal toxicity.

 

Justification for classification or non-classification

Based on the above studies on test chemical, it can be concluded that LD50 value is >2000 mg/kg bw, for acute oral and acute dermal toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute oral and acute dermal toxicity. For acute inhalation toxicity wavier was added so, not possible to classify.