Registration Dossier

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, which is reported to be 8.85E-018 Pa. Thus, exposure to inhalable dust, mist and vapour of the chemical is highly unlikely. 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.

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:

not specified

Sex:

male

Details on test animals or test system and environmental conditions:

1. not specified
2. not specified
3. not specified

Route of administration:

oral: unspecified

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

1. not specified
2. not specified
3. not specified

Doses:

1. 2340 mg/kg
2. 15800 mg/kg
3. 10800 mg/kg

No. of animals per sex per dose:

1. not specified
2. not specified
3. not specified

Control animals:

not specified

Details on study design:

1. not specified
2. not specified
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:

male

Dose descriptor:

LD50

Effect level:

2 340 mg/kg bw

Based on:

test mat.

Remarks on result:

other: 50% mortality was observed

Sex:

not specified

Dose descriptor:

LD50

Effect level:

> 15 800 mg/kg bw

Based on:

test mat.

Remarks on result:

other: No mortality was observed

Sex:

not specified

Dose descriptor:

LD50

Effect level:

> 10 800 mg/kg bw

Based on:

test mat.

Remarks on result:

other: No mortality was observed

Mortality:

1. 50% mortality was observed at 2340 mg/kg.
2. No mortality was observed at 15800 mg/kg bw.
3. No mortality was observed at 10800 mg/kg bw.

Clinical signs:

other: 1. not specified 2. not specified 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 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 –

Acute oral toxicity test was conducted using the given test chemical in male rat at the concentration of 2340 mg/kg bw. 50% mortality was observed at 2340 mg/kg bw. Hence, the LD50 was considered to be 2340 mg/kg bw, when male rat was treated with test chemical via oral route.

The above study is supported with another study mentioned in databases and secondary sources for the test chemical. The acute oral toxicity test was conducted using test chemical in rat at the concentration of 15800 mg/kg bw. No mortality was observed at 15800 mg/kg bw. Hence, LD50 was considered to be >15800 mg/kg bw, when rat was treated with test chemical via oral route.

Both the above studies are further supported with the study mentioned in database for the test chemical. The acute oral toxicity study of the test chemical was conducted in rats at the concentration of 10800 mg/kg bw. No mortality was observed in treated rats at 10800 mg/kg bw. Therefore, LD50 was considered to be >10800 mg/kg bw, when rats were treated with the given test chemical via oral route.

Thus, based on the above summarised studies on test chemical, it can be concluded that the 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:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Quality of whole database:

Data is Klimisch 2 and from database.

Reference

Endpoint:: acute toxicity: inhalation
Data waiving:: other justification
Justification for data waiving:: other:

Quality of whole database:

Waiver

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. rabbit 3. rat

Strain:

not specified

Sex:

not specified

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:

unchanged (no vehicle)

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. 5000 mg/kg
2. 5000 mg/kg
3. 10000 mg/kg

No. of animals per sex per dose:

1. not specified
2. not specified
3. not specified

Control animals:

not specified

Details on study design:

1. not specified
2. not specified
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:

> 5 000 mg/kg bw

Based on:

test mat.

Sex:

not specified

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: No mortality was observed

Sex:

not specified

Dose descriptor:

LD50

Effect level:

> 10 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: No mortality was observed

Mortality:

1. No mortality was observed.
2. No mortality was observed at 5000 mg/kg bw.
3. No mortality was observed at 10000 mg/kg bw.

Clinical signs:

other: 1. not specified 2. not specified 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 ratsand rabbits for test chemical. The studies are summarized as below –

The acute dermal toxicity test was conducted using the given test chemical in rat at the concentration of 5000 mg/kg bw. No mortality was observed at 5000 mg/kg bw. Hence, LD50 was considered to be>5000 mg/kg bw, when rat was treated with test chemical by dermal application.

The above study is supported with another study conducted on rabbits for the test chemical. The acute dermal toxicity test was conducted using the given test chemical in rat at the concentration of 5000 mg/kg bw. No mortality was observed at 5000 mg/kg bw. Hence, the LD50 was considered to be >5000 mg/kg bw, when rat was treated with test chemical by dermal application to skin.

Both the above studies are further supported with the study mentioned in authoritative database and handbook. The acute dermal toxicity test was conducted using test chemical in rat at the concentration of 10000 mg/kg bw. No mortality was observed at 10000 mg/kg bw. Hence, the LD50 value was considered to be >10000 mg/kg bw, when rat was treated with test chemical by dermal application to skin.

Thus, based on the above summarised studies on test chemical, it can be concluded that the 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:

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 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 –

Acute oral toxicity test was conducted using the given test chemical in male rat at the concentration of 2340 mg/kg bw. 50% mortality was observed at 2340 mg/kg bw. Hence, the LD50 was considered to be 2340 mg/kg bw, when male rat was treated with test chemical via oral route.

The above study is supported with another study mentioned in databases and secondary sources for the test chemical. The acute oral toxicity test was conducted using test chemical in rat at the concentration of 15800 mg/kg bw. No mortality was observed at 15800 mg/kg bw. Hence, LD50 was considered to be >15800 mg/kg bw, when rat was treated with test chemical via oral route.

Both the above studies are further supported with the study mentioned in database for the test chemical. The acute oral toxicity study of the test chemical was conducted in rats at the concentration of 10800 mg/kg bw. No mortality was observed in treated rats at 10800 mg/kg bw. Therefore, LD50 was considered to be >10800 mg/kg bw, when rats were treated with the given test chemical via oral route.

Thus, based on the above summarised studies on test chemical, it can be concluded that the 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, which is reported to be 8.85E-018 Pa. Thus, exposure to inhalable dust, mist and vapour of the chemical is highly unlikely. Therefore this study is considered for waiver.

In one case, the acute inhalation toxicity study was conducted by using the given test chemical in rats at the concentration of 1000 mg/m3. No mortality was observed at 1000 mg/m3. Therefore, the LC50 was considered to be >1000 mg/m3, when rats were treated with test chemical by inhalation.

From the above study, the details on possible symptoms or findings were not provided. Hence, this study is difficult to classify for acute inhalation toxicity.

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 ratsand rabbits for test chemical. The studies are summarized as below –

The acute dermal toxicity test was conducted using the given test chemical in rat at the concentration of 5000 mg/kg bw. No mortality was observed at 5000 mg/kg bw. Hence, LD50 was considered to be>5000 mg/kg bw, when rat was treated with test chemical by dermal application.

The above study is supported with another study conducted on rabbits for the test chemical. The acute dermal toxicity test was conducted using the given test chemical in rat at the concentration of 5000 mg/kg bw. No mortality was observed at 5000 mg/kg bw. Hence, the LD50 was considered to be >5000 mg/kg bw, when rat was treated with test chemical by dermal application to skin.

Both the above studies are further supported with the study mentioned in authoritative database and handbook. The acute dermal toxicity test was conducted using test chemical in rat at the concentration of 10000 mg/kg bw. No mortality was observed at 10000 mg/kg bw. Hence, the LD50 value was considered to be >10000 mg/kg bw, when rat was treated with test chemical by dermal application to skin.

Thus, based on the above summarised studies on test chemical, it can be concluded that the 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.

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.