Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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 and mice for the test chemical. The LD50 value is 7500 mg/kg bw. The study concluded that LD50 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 dose (LC50) was considered based on different studies conducted on rats for the given test chemical. The LC50 value is 20000 mg/m3. The study concluded that LC50 value is >5 mg/L(>5000 mg/m3), for acute inhalation toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute inhalation toxicity.

Acute Dermal toxicity:

The acute dermal toxicity dose (LD50) was considered based on different studies conducted on rabbits for the given test chemical. The LD50 value is 4290 mg/kg bw. The study 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:
calculation (if not (Q)SAR)
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
accepted calculation method
Justification for type of information:
Data is from Danish QSAR
Qualifier:
according to guideline
Guideline:
other: Predicted data
Principles of method if other than guideline:
Prediction is done by using Danish QSAR
GLP compliance:
not specified
Test type:
other: not specified
Limit test:
no
Species:
rat
Strain:
not specified
Sex:
not specified
Details on test animals or test system and environmental conditions:
not specified
Route of administration:
oral: unspecified
Vehicle:
not specified
Details on oral exposure:
not specified
Doses:
7500 mg/kg bw
No. of animals per sex per dose:
not specified
Control animals:
not specified
Details on study design:
not specified
Statistics:
not specified
Preliminary study:
not specified
Sex:
not specified
Dose descriptor:
LD50
Effect level:
7 500 mg/kg bw
Based on:
test mat.
Remarks on result:
other: 50% mortality observed
Mortality:
not specified
Clinical signs:
other: not specified
Gross pathology:
not specified
Other findings:
not specified
Interpretation of results:
other: Not classified
Conclusions:
The acute oral toxicity dose (LD50) value was estimated to be 7500 mg/kg bw, when rats were treated with the given test chemical via oral route.

Executive summary:

Based on the QSAR prediction done using the Danish (Q)SAR Database, the acute oral toxicity was estimated for the given test chemical. The LD50 was estimated to be 7500 mg/kg bw with Reliability Index 0.66 (0.5-0.75 = moderate prediction quality), when rats were treated with the given test chemical via oral route.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
7 500 mg/kg bw
Quality of whole database:
Data is Klimisch 2 and from prediction report.

Acute toxicity: via inhalation route

Link to relevant study records
Reference
Endpoint:
acute toxicity: inhalation
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 of various test substances
Justification for type of information:
Data for the test chemical is summarized based on the various chemicals
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 2 acute inhalation toxicity studies as - WoE-2 and WoE-3
Acute Inhalation 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: 2. not specified 3. Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
2. not specified
3. TEST ANIMALS
- Age at study initiation: Approximately 9 weeks old
Route of administration:
other: 2. inhalation 3. inhalation: aerosol
Type of inhalation exposure:
other: 2. inhalation 3. whole body
Vehicle:
other: 2. inhalation 3. water
Mass median aerodynamic diameter (MMAD):
1.6 µm
Geometric standard deviation (GSD):
2.19
Details on inhalation exposure:
2. not specified
3. GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: exposure chamber
- Exposure chamber volume: 120-liter
- Source and rate of air: Dried air was passed into the nebulizer at a pressure of 50 p.s.i. and the resulting aerosol was passed into the exposure chamber. Every 30 minutes during exposure, a sample of chamber atmosphere was drawn through a tared fiberglass filter at the rate of 1.8 l/min.
- Method of particle size determination: The particle size distribution for the test material was determined with a cascade impactor.
- Treatment of exhaust air: After one minute the filter was removed, dried in a drying oven to a constant weight and the final weight recorded. The change in weight represented the amount of hydrolyzed silane collected and represents approximately 49.77% of the test material. This factor, along with the volume of air sampled, was used to calculate the concentration of test material in the chamber air.

TEST ATMOSPHERE
- Brief description of analytical method used: The ethanol concentration in the exposure chamber, formed from the reaction of the test material with water, was determined five times during the four-hour exposure period by gas chromatographic analysis. Gravimetric chamber analysis indicated that the mean chamber concentration was 7.35 (6.65 to 9.52) mg/liter.

VEHICLE
- Concentration of test material in vehicle (if applicable): 60% (w/w)
- Justification of choice of vehicle: Distilled water was used to make a 60% (w/w) solution of the test material. The mixture was stirred for one hour to ensure complete dissolution of the test material.

TEST ATMOSPHERE (if not tabulated)
- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.): The mass mean aerodynamic diameter was 1.6 micrometers with a geometric standard deviation of 2.19.
Analytical verification of test atmosphere concentrations:
yes
Duration of exposure:
8 h
Concentrations:
2. 20000 mg/m3
3. 7.35 (6.65 to 9.52) mg/liter
No. of animals per sex per dose:
2. not specified
3. Total = 5
Control animals:
not specified
Details on study design:
2. not specified
3. - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were weighed just before exposure and at 7 and 14 days after exposure. All rats were observed frequently on the day of the test and daily during the subsequent 14-day observation period.
- Necropsy of survivors performed: yes, necropsy findings, included doses affected, severity and number of animals affected.
Statistics:
2. not specified
3. not specified
Preliminary study:
2. not specified
3. not specified
Sex:
not specified
Dose descriptor:
LC50
Effect level:
20 000 mg/m³ air
Based on:
test mat.
Exp. duration:
8 h
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 7 350 mg/m³ air
Based on:
test mat.
Exp. duration:
4 h
Mortality:
2. 50% mortality observed at 20000 mg/m3 in treated animals.
3. No mortality was observed at 7.35 mg/L in treated animals.
Clinical signs:
other: 2. not specified 3. During exposure, a dense fog was present in the animal chamber, preventing observation of the test animals. After exposure, slow righting reflex, labored breathing, hypoactivity, ataxia and discharge from the mouth, nose and eyes were
Body weight:
2. not specified
3. All animals gained weight during the study period.
Gross pathology:
2. not specified
3. No remarkable gross pathologic findings were seen.
Other findings:
2. not specified
3. not specified
Interpretation of results:
other: Not classified
Conclusions:
According to CLP regulation, the given test chemical cannot be classified for acute inhalation toxicity, as the LC50 value is >5 mg/L.
Executive summary:

In different studies, the given test chemical has been investigated for acute inhalation 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 the given test chemical. The studies are summarized as below -

 

The reported study was mentioned in authoritative database and conducted to determine the acute inhalation toxicity profile of the given test chemical in rats at the dose concentration of 20000 mg/m3 via inhalation route for 8 hours exposure. Animals were observed for mortality. 50% mortality observed at 20000 mg/m3. Hence, the LC50 value was considered to be 20000 mg/m3, when rats was treated with the given test chemical via inhalation route for 8 hours exposure.

 

The above study is supported with another study mentioned in authoritative database and secondary source and conducted to determine the acute inhalation toxicity profile as per OECD Guide-line 403 "Acute Inhalation Toxicity" in 5 male and female Wistar rats at the mean chamber concentration of 7.35 (6.65 to 9.52) mg/liter by inhalation route via aerosol to whole body exposure for 4 hours.

Distilled water was used to make a 60% (w/w) solution of the test material. The mixture was stirred for one hour to ensure complete dissolution of the test material. A Solo-Sphere® nebulizer containing the diluted test material was connected to a 120-liter exposure chamber. Dried air was passed into the nebulizer at a pressure of 50 p.s.i. and the resulting aerosol was passed into the exposure chamber. Every 30 minutes during exposure, a sample of chamber atmosphere was drawn through a tared fibreglass filter at the rate of 1.8 l/min. After one minute the filter was removed, dried in a drying oven to a constant weight and the final weight recorded. The change in weight represented the amount of hydrolyzed silane collected and represents approximately 49.77% of the test material. This factor, along with the volume of air sampled, was used to calculate the concentration of test material in the chamber air. The particle size distribution for the test material was determined with a cascade impactor. The ethanol concentration in the exposure chamber, formed from the reaction of the test material with water, was determined five times during the four-hour exposure period by gas chromatographic analysis. Gravimetric chamber analysis indicated that the mean chamber concentration was 7.35 (6.65 to 9.52) mg/liter. The mass mean aerodynamic diameter was 1.6 micrometers with a geometric standard deviation of 2.19.

Animals were weighed just before exposure and at 7 and 14 days after exposure. All rats were observed frequently on the day of the test and daily during the subsequent 14-day observation period. Necropsy findings, included doses affected, severity and number of animals affected.

No mortality was observed at 7.35 mg/L in treated animals. During exposure, a dense fog was present in the animal chamber, preventing observation of the test animals. After exposure, slow righting reflex, labored breathing, hypoactivity, ataxia and discharge from the mouth, nose and eyes were apparent. At 3 days, the animals were fully recovered. There were no other clinical signs. All animals gained weight during the study period. No remarkable gross pathologic findings were seen.

Under the condition of the study, the LC50 value was considered to be >7.35 mg/L (>7350 mg/m3), when 5 male and female Wistar rats was treated with the given test chemical by inhalation route via aerosol to whole body exposure for 4 hours.

 

Thus, based on the above summarised studies on test chemical, it can be concluded that LC50 value is >5 mg/L, for acute inhalation toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute inhalation toxicity.

 

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LC50
Value:
20 000 mg/m³ air
Quality of whole database:
Data is Klimisch 2 and from authoritative database.

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
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
Qualifier:
according to guideline
Guideline:
other: As mentioned below
Principles of method if other than guideline:
WoE report is based on 2 acute dermal toxicity studies as- WoE 2 and WoE 3.
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:
rabbit
Strain:
other: 2. New Zealand White 3. not specified
Sex:
male/female
Details on test animals or test system and environmental conditions:
2. not specified
3. not specified
Type of coverage:
other: 2. occlusive 3. Dermal
Vehicle:
not specified
Details on dermal exposure:
2. REMOVAL OF TEST SUBSTANCE
- Washing (if done): After the contact period, excess test material is removed to prevent ingestion.
- Time after start of exposure: 24 hours
3. not specified
Duration of exposure:
2. 24 hours
3. not specified
Doses:
2. 8, 4, 2, and 1 g/kg
3. 6300 mg/kg bw
No. of animals per sex per dose:
2. 10/dose
3. not specified
Control animals:
not specified
Details on study design:
2. - Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: Animals were observed for mortality and clinical signs.
3. not specified
Statistics:
2. not specified
3. not specified
Preliminary study:
2. not specified
3. not specified
Sex:
male/female
Dose descriptor:
LD50
Effect level:
4 290 mg/kg bw
Based on:
test mat.
95% CL:
2 900 - 6 340
Sex:
not specified
Dose descriptor:
LD50
Effect level:
6 300 mg/kg bw
Based on:
test mat.
Mortality:
2. Days to death for the five male animals in the 8 g/kg group were 1, 1,1,2,2. All other deaths occurred more than 24 hours after dosing.
3. not specified
Clinical signs:
other: 2. Local cutaneous effects included erythema, edema, ecchymosis, necrosis, desquamation, fissuring, ulceration, alopecia and scabs. Blood in rectal and urogenital areas apparent in several animals (especially at 4 g/kg). Hemorrhaging under the skin eviden
Gross pathology:
2. Gross pathologic findings included discolored lungs (red, pink, or mottled), lungs with dark red foci (in one), mottled tan livers, stomachs with dark areas of hemorrhages, stomach with black foci (in one), tan or hemorrhaged kidneys, ureters and urethra with hemorrhages (in one), bladders filled with red liquid (1 with a dark red clot) and the untreated skin of 2 animals stained red.
3. not specified
Other findings:
2. not specified
3. not specified
Interpretation of results:
other: Not classified
Conclusions:
According to CLP regulation, the given test chemical cannot be classified for acute dermal toxicity, as the LD50 value is 4290 mg/kg bw i.e. >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 rabbits for test chemical. The studies are summarized as below -

 

The reported study was mentioned in authoritative database and secondary report and conducted to determine the acute dermal toxicity profile of the given test chemical as per EPA TSCA Guideline 798-1100 in 10/dose male and female New Zealand white rabbits at the dose concentrations of 8, 4, 2, and 1 g/kg bw by dermal application occlusively.

After the contact period, excess test material is removed to prevent ingestion. Animals were observed for mortality and clinical signs. Necropsy of survivors performed. Days to death for the five male animals in the 8 g/kg group were 1, 1,1,2,2. All other deaths occurred more than 24 hours after dosing. Local cutaneous effects included erythema, edema, ecchymosis, necrosis, desquamation, fissuring, ulceration, alopecia and scabs. Blood in rectal and urogenital areas apparent in several animals (especially at 4 g/kg). Haemorrhaging under the skin evident at 4 g/kg. Other signs of toxicity included sluggishness, salivation (in one), unsteady gait (in 2), prostration, and diarrhoea (in one). Survivors recovered at 2 to 4 days.

Gross pathologic findings included discoloured lungs (red, pink, or mottled), lungs with dark red foci (in one), mottled tan livers, stomachs with dark areas of haemorrhages, stomach with black foci (in one), tan or haemorrhaged kidneys, ureters and urethra with haemorrhages (in one), bladders filled with red liquid (1 with a dark red clot) and the untreated skin of 2 animals stained red.

Hence, the LD50 value was considered to be 4290 mg/kg bw, with 95% confidence limits of 2900 to 6340 mg/kg bw, when 10/dose male and female New Zealand white rabbits was treated with the given test chemical by dermal application occlusively.

 

The above study is supported with another study mentioned in authoritative database and conducted in rabbits using the given test chemical at the dose concentration of 6300 mg/kg bw. Animals were observed for mortality. 50% mortality observed at 6300 mg/kg bw. Hence, the LD50 value was considered to be 6300 mg/kg bw, when rabbits was treated with the given 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, 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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
4 290 mg/kg bw
Quality of whole database:
Data is Klimisch 2 and from authoritative 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 and mice for test chemical. The studies are summarized as below -

 

Based on the QSAR prediction done using the Danish (Q)SAR Database, the acute oral toxicity was estimated for the given test chemical. The LD50 was estimated to be 7500 mg/kg bw with Reliability Index 0.66 (0.5-0.75 = moderate prediction quality), when rats were treated with the given test chemical via oral route.

 

The above prediction is supported with another prediction study based on the QSAR prediction done using the Danish (Q)SAR Database, the acute oral toxicity was estimated for the given test chemical. The LD50 was estimated to be 3500 mg/kg bw with Reliability Index 0.67 (0.5-0.75 = moderate prediction quality), when mice were treated with the given test chemical via oral route.

 

These prediction studies are supported with the study mentioned in authoritative database for the given test chemical. The acute oral toxicity study was conducted in rats at the dose concentration of 6270 mg/kg bw. Animals were observed for mortality. 50% mortality observed at 6270 mg/kg bw. Hence, the LD50 value was considered to be 6270 mg/kg bw, when rats was treated with the given test chemical via oral route.

 

All the above studies arefurther supported with the data available in authoritative databases for the test chemical. The acute oral toxicity study was conducted in rats at the dose concentration of 9280 mg/kg bw. Animals were observed for mortality. 50% mortality observed at 9280 mg/kg bw. Hence, the LD50 value was considered to be 9280 mg/kg bw, when rats was treated with the given test chemical via oral route.

 

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

In different studies, the given test chemical has been investigated for acute inhalation 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 the given test chemical. The studies are summarized as below -

 

The reported study was mentioned in authoritative database and conducted to determine the acute inhalation toxicity profile of the given test chemical in rats at the dose concentration of 20000 mg/m3 via inhalation route for 8 hours exposure. Animals were observed for mortality. 50% mortality observed at 20000 mg/m3. Hence, the LC50 value was considered to be 20000 mg/m3, when rats was treated with the given test chemical via inhalation route for 8 hours exposure.

 

The above study is supported with another study mentioned in authoritative database and secondary source and conducted to determine the acute inhalation toxicity profile as per OECD Guide-line 403 "Acute Inhalation Toxicity" in 5 male and female Wistar rats at the mean chamber concentration of 7.35 (6.65 to 9.52) mg/liter by inhalation route via aerosol to whole body exposure for 4 hours.

Distilled water was used to make a 60% (w/w) solution of the test material. The mixture was stirred for one hour to ensure complete dissolution of the test material. A Solo-Sphere® nebulizer containing the diluted test material was connected to a 120-liter exposure chamber. Dried air was passed into the nebulizer at a pressure of 50 p.s.i. and the resulting aerosol was passed into the exposure chamber. Every 30 minutes during exposure, a sample of chamber atmosphere was drawn through a tared fibreglass filter at the rate of 1.8 l/min. After one minute the filter was removed, dried in a drying oven to a constant weight and the final weight recorded. The change in weight represented the amount of hydrolyzed silane collected and represents approximately 49.77% of the test material. This factor, along with the volume of air sampled, was used to calculate the concentration of test material in the chamber air. The particle size distribution for the test material was determined with a cascade impactor. The ethanol concentration in the exposure chamber, formed from the reaction of the test material with water, was determined five times during the four-hour exposure period by gas chromatographic analysis. Gravimetric chamber analysis indicated that the mean chamber concentration was 7.35 (6.65 to 9.52) mg/liter. The mass mean aerodynamic diameter was 1.6 micrometers with a geometric standard deviation of 2.19.

Animals were weighed just before exposure and at 7 and 14 days after exposure. All rats were observed frequently on the day of the test and daily during the subsequent 14-day observation period. Necropsy findings, included doses affected, severity and number of animals affected.

No mortality was observed at 7.35 mg/L in treated animals. During exposure, a dense fog was present in the animal chamber, preventing observation of the test animals. After exposure, slow righting reflex, labored breathing, hypoactivity, ataxia and discharge from the mouth, nose and eyes were apparent. At 3 days, the animals were fully recovered. There were no other clinical signs. All animals gained weight during the study period. No remarkable gross pathologic findings were seen.

Under the condition of the study, the LC50 value was considered to be >7.35 mg/L (>7350 mg/m3), when 5 male and female Wistar rats was treated with the given test chemical by inhalation route via aerosol to whole body exposure for 4 hours.

 

Thus, based on the above summarised studies on test chemical, it can be concluded that LC50 value is >5 mg/L, for acute inhalation toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified 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 rabbits for test chemical. The studies are summarized as below -

 

The reported study was mentioned in authoritative database and secondary report and conducted to determine the acute dermal toxicity profile of the given test chemical as per EPA TSCA Guideline 798-1100 in 10/dose male and female New Zealand white rabbits at the dose concentrations of 8, 4, 2, and 1 g/kg bw by dermal application occlusively.

After the contact period, excess test material is removed to prevent ingestion. Animals were observed for mortality and clinical signs. Necropsy of survivors performed. Days to death for the five male animals in the 8 g/kg group were 1, 1,1,2,2. All other deaths occurred more than 24 hours after dosing. Local cutaneous effects included erythema, edema, ecchymosis, necrosis, desquamation, fissuring, ulceration, alopecia and scabs. Blood in rectal and urogenital areas apparent in several animals (especially at 4 g/kg). Haemorrhaging under the skin evident at 4 g/kg. Other signs of toxicity included sluggishness, salivation (in one), unsteady gait (in 2), prostration, and diarrhoea (in one). Survivors recovered at 2 to 4 days.

Gross pathologic findings included discoloured lungs (red, pink, or mottled), lungs with dark red foci (in one), mottled tan livers, stomachs with dark areas of haemorrhages, stomach with black foci (in one), tan or haemorrhaged kidneys, ureters and urethra with haemorrhages (in one), bladders filled with red liquid (1 with a dark red clot) and the untreated skin of 2 animals stained red.

Hence, the LD50 value was considered to be 4290 mg/kg bw, with 95% confidence limits of 2900 to 6340 mg/kg bw, when 10/dose male and female New Zealand white rabbits was treated with the given test chemical by dermal application occlusively.

 

The above study is supported with another study mentioned in authoritative database and conducted in rabbits using the given test chemical at the dose concentration of 6300 mg/kg bw. Animals were observed for mortality. 50% mortality observed at 6300 mg/kg bw. Hence, the LD50 value was considered to be 6300 mg/kg bw, when rabbits was treated with the given 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, 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.

 

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 and LC50 value is >5 mg/L for acute inhalation toxicity. Thus, comparing these values with the criteria of CLP regulation, the given test chemical cannot be classified for acute oral, acute dermal and acute inhalation toxicity.