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EC number: 203-232-2 | CAS number: 104-74-5
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
![](https://poisoncentres.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Endpoint summary
Administrative data
Description of key information
Acute oral toxicity:
The acute oral toxicity dose (LD50) was considered based on experimental study conducted on rats for the test chemical.The study concluded that the LD50 value isbetween50-300 mg/kg bw, for acute oral toxicity.Thus, comparing this value with the criteria of CLP regulation, the given test chemical can be classified in “Category 3” 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 0.0046 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 experimental study conducted on rats for the test chemical. The study concluded that the LD50 value is >1000 mg/kg bw, for acute dermal toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical can be classified in “Category 4 (>1000-2000 mg/kg bw)” for acute dermal toxicity.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- Data is from experimental study report.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Principles of method if other than guideline:
- The purpose of this study was to access the toxicological profile of the test item to a single administration via oral route to Sprague-Dawley rats.
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- no
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: National Institute of Biosciences, Pune.
- Females nulliparous and non-pregnant: yes
- Age at study initiation: Female rats of the age of approximately 8 to 12 weeks old were used at the commencement of its dosing.
- Weight at study initiation: Body weight range was 192.2 to 207.1 grams.
Body weights at the start : Female Mean: 199.74 g (= 100 %); Minimum : 192.2 g (- 3.78 %); Maximum : 207.1 g (+ 3.68 %)
- Identification: Each female rat was individually identified by the picric acid marking.
- Fasting period before study: Approximately 16 hours or more.
- Housing: The rats were housed in polycarbonate cages.
- Diet (e.g. ad libitum): Rodent feed supplied by the Nutrivet Life Sciences, Pune, was provided ad libitum from individual feeders.
- Water (e.g. ad libitum): Water was provided ad libitum from individual bottles attached to the cages. All water was from a local source and passed through the reverse osmosis membrane before use.
- Acclimation period: 5 days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.0 to 22.0 degree centigrade.
- Humidity (%): 54.4% to 59.3%
- Air changes (per hr): Ten to fifteen air changes per hour.
- Photoperiod (hrs dark / hrs light): An artificial light and dark cycle of 12 hours each was provided to the room.
IN-LIFE DATES:13-10-2017 to 31-10-2017 - Route of administration:
- oral: gavage
- Vehicle:
- water
- Remarks:
- Distilled water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle:300 mg/kg, 50 mg/kg and 50 mg/kg
MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg body weight.
DOSAGE PREPARATION (if unusual): The test item was dissolved in distilled water. The formulation was prepared fresh. The test item was administered in the dose volume of 10 ml/kg bw. - Doses:
- Dose Group I : 300 mg/kg
Dose Group II : 50 mg/kg
Dose Group II : 50 mg/kg - No. of animals per sex per dose:
- Three females were used at each step.
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Twice daily
- Necropsy of survivors performed: Yes
- Other examinations performed: Clinical Observations and General Appearance: Animals were observed for clinical signs, mortality and morbidity, until sacrifice.
Onset, duration and severity of any sign were recorded. The clinical signs and mortality observations were conducted at immediately (0 to 5 minutes), 5, 10, 30, 60 minutes, 2, 4 and 6 hours on the day of dosing and once daily thereafter for 14 day. Daily observation was done as far as possible at the same time.
The observations were included general clinical signs, observations of eyes, mucous membranes, respiratory, circulatory system and behavior pattern.
Body weights: Individual animal body weights were recorded, before fasting, prior to administration of the test item (fasting body weights), weekly thereafter and at termination on day 14. Weight changes were calculated and recorded.
Gross Pathology: Necropsy was performed on all animals, found dead and sacrificed at the end of the study. Macroscopic examination of all the orifices, cavities and tissues were made and the findings were recorded. All animals surviving the study period were sacrificed by the carbon dioxide asphyxiation technique (day 15).
Histopathology: No gross abnormalities were observed in animals sacrificed terminally hence, no histopathology was performed. - Statistics:
- not specified
- Preliminary study:
- not specified
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 50 - 300 mg/kg bw
- Based on:
- test mat.
- Mortality:
- Group I Step I : Two animals died at 6 hours and one animal died on day 1 after the dosing.
Group II Step I : All animals survived through the study period of 14 days.
Group II Step II : All animals survived through the study period of 14 days. - Clinical signs:
- other: Group I Step I : Animals treated at the dose level of 300 mg/kg body weight resulted in diarrhoea and reduced locomotor activity with onset at 30 minutes to 1 hour after the dosing. Group II Step I : Animals treated at the dose level of 50 mg/kg body wei
- Gross pathology:
- Gross pathological examination did not reveal any abnormalities in all animals from 300 mg/kg and 50 mg/kg dose groups.
- Other findings:
- not specified
- Interpretation of results:
- Category 3 based on GHS criteria
- Conclusions:
- Under the condition of the study, the acute oral LD50 value of the given test chemical was considered in between 50 – 300 mg/kg body weight. Thus, it was concluded that the acute toxicity study of test chemical, when administered via oral route in Sprague Dawley rats falls into the “Category 3” according to criteria of CLP.
- Executive summary:
The reported study was designed and conducted 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 Sprague Dawley rats.
Initially, three female animals were treated at the dose level of 300 mg/kg body weight of the test item (Step - I). Administration of the test item at 300 mg/kg resulted in diarrhoea and reduced locomotor activity with onset at 30 minutes to 1 hour after the dosing. Two animals died at 6 hours and one animal died on day 1 after the dosing.
As mortality was observed at 300 mg/kg dose group, additional three female animals were treated with the lower dose of 50 mg/kg of the test item (Step - I).
Administration of the test item at 50 mg/kg resulted in diarrhoea with onset at 1 hour after the dosing and no mortality at 24 hours after the dosing. As no mortality was observed at 24 hours after the dosing, three additional female animals were added to the study and treated with the dose of 50 mg/kg of the test item (Step - II). Administration of the test item at 50 mg/kg resulted in diarrhoea with onset at 1 hour after the dosing and no mortality at 24 hours after the dosing.
All animals from 50 mg/kg dose group survived through the study period of 14 days. Gross pathological examination did not reveal any abnormalities in all animals from 300 mg/kg and 50 mg/kg dose groups.
Under the condition of the study, the acute oral LD50 value of the given test chemical was considered in between 50 – 300 mg/kg body weight. Thus, it was concluded that the acute toxicity study of test chemical, when administered via oral route in Sprague Dawley rats falls into the “Category 3” according to criteria of CLP.
Reference
Table No. I
Summary of Clinical Signs of Toxicity and Mortality
Laboratory Test Item Code :TAS/122/054
Test System : Sprague Dawley Rat
Sex : Female
Group I :
Step No. |
Dose mg/kg |
Observed Signs |
Total Number of Animals |
Animal Nos. |
Period of signs in days From - to |
Mortality |
I |
300 |
Diarrhoea |
3 |
1 2 3 |
1 hr. - 4 hrs. 30 min. - 4 hrs. 1 hr. - 6 hrs. |
3/3 |
Reduced locomotor activity |
3 |
1 2 3 |
1 hr. - 4 hrs. 30 min. - 4 hrs. 1 hr. - 6 hrs. |
Group II :
Step No. |
Dose mg/kg |
Observed Signs |
Total Number of Animals |
Animal Nos. |
Period of signs in days From - to |
Mortality |
I |
50 |
Diarrhoea |
3 |
4,5 6 |
1 hr. - 4 hrs. 1 hr. - 6 hrs. |
0/3 |
Group II :
Step No. |
Dose mg/kg |
Observed Signs |
Total Number of Animals |
Animal Nos. |
Period of signs in days From - to |
Mortality |
II |
50 |
Diarrhoea |
3 |
7 8,9 |
1 hr. - 6 hrs. 1 hr. - 4 hrs. |
0/3 |
Table No.II
Mean Body Weight and Percent Body Weight Gain (g)
Laboratory Test Item Code :TAS/122/054
Test System : Sprague Dawley Rat
Sex : Female
Group I :
Step No. |
Dose (mg/kg body weight) |
|
Before Fasting Body weight |
Body weight Day 7 |
% body weight gain day 0-7 |
Body weight Day 14 |
% body weight gain day 7- 14 |
% body weight gain day 0- 14 |
I |
300 |
Mean |
195.23 |
- |
- |
- |
- |
- |
± SD |
2.87 |
- |
- |
- |
- |
- |
Group II :
Step No. |
Dose (mg/kg body weight) |
|
Before Fasting Body weight |
Body weight Day 7 |
% body weight gain day 0-7 |
Body weight Day 14 |
% body weight gain day 7- 14 |
% body weight gain day 0- 14 |
I |
50 |
Mean |
201.77 |
214.87 |
6.49 |
232.20 |
8.07 |
15.09 |
± SD |
3.40 |
4.15 |
0.30 |
5.14 |
1.78 |
1.98 |
Group II :
Step No. |
Dose (mg/kg body weight) |
|
Before Fasting Body weight |
Body weight Day 7 |
% body weight gain day 0-7 |
Body weight Day 14 |
% body weight gain day 7- 14 |
% body weight gain day 0- 14 |
II |
50 |
Mean |
202.23 |
215.20 |
6.41 |
232.37 |
7.97 |
14.89 |
± SD |
4.54 |
5.58 |
0.58 |
6.80 |
0.93 |
0.85 |
Table No.III
Summary of Gross Pathological Findings
Laboratory Test Item Code :TAS/122/054
Test System : Sprague Dawley Rat
Sex : Female Group I :
Step No. |
Dose mg/kg |
Animal Numbers |
Animal Fate |
Gross Pathological Findings |
I |
300 |
1 - 3 |
FD |
No abnormality detected |
Group II :
Step No. |
Dose mg/kg |
Animal Numbers |
Animal Fate |
Gross Pathological Findings |
I |
50 |
4 - 6 |
TS |
No abnormality detected |
Group II :
Step No. |
Dose mg/kg |
Animal Numbers |
Animal Fate |
Gross Pathological Findings |
II |
50 |
7 - 9 |
TS |
No abnormality detected |
FD = Found dead
TS = Terminal sacrifice
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 200 mg/kg bw
- Quality of whole database:
- Data is Klimisch 1 and from study report.
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Data waiving:
- other justification
- Justification for data waiving:
- other:
- Clinical signs:
- other:
Reference
Endpoint conclusion
- Quality of whole database:
- Waiver
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- Data is from experimental study report.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Principles of method if other than guideline:
- This study was designed to determine the dermal LD50 of the test item (up to 2000 mg/kg) or to establish a non-lethal dose level of 2000 milligram of test item per kilogram of body weight.
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: National Institute of Biosciences, Pune.
- Females (if applicable) nulliparous and non-pregnant: Yes
- Age at study initiation: Young adult female rats aged between 8 – 10 weeks were used.
- Weight at study initiation: The weight ranges of approximately 222.8 to 245.7 grams at initiation of dosing were used.
Body weights at the start : Female Mean: 235.02 g (= 100 %); Minimum : 222.8 g (- 5.20 %); Maximum : 245.7 g (+ 4.54 %)
-Identification: Each rat was individually identified by the cage number.
- Housing: The rats were individually housed in polycarbonate cages with paddy husk as bedding.
- Diet (e.g. ad libitum): Rodent feed supplied by the Nutrivet Life Sciences, Pune, was provided ad libitum from individual feeders.
- Water (e.g. ad libitum): Water was provided ad libitum from individual bottles attached to the cages. All water was from a local source and passed through the reverse osmosis membrane before use.
- Acclimation period: 5 days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.2 to 21.8 degree centigrade.
- Humidity (%): 56.0% to 59.1%
- Air changes (per hr): Ten to fifteen air changes per hour.
- Photoperiod (hrs dark / hrs light): An artificial light and dark cycle of 12 hours each was provided to the room.
IN-LIFE DATES: 11-09-2017 to 28-12-2017 - Type of coverage:
- occlusive
- Vehicle:
- water
- Remarks:
- (Distilled water)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: Trunk (dorsal surface and sides from scapular to pelvic area)
- % coverage: Approximately 10% of the total body surface area.
- Type of wrap if used: Porous gauze dressing and non-irritating tape.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Distilled water was used to remove residual test item.
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw
- For solids, paste formed: Yes - Duration of exposure:
- 24 hours
- Doses:
- Dose Range Finding Study:
Group I : 200 mg/kg body weight
Group I : 1000 mg/kg body weight
Group I : 2000 mg/kg body weight
Main Study:
Group II : 1000 mg/kg body weight - No. of animals per sex per dose:
- Total No. of animals : 5
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Twice daily
- Necropsy of survivors performed: Yes
- Other examinations performed: Clinical Observations and General Appearance: Animals were observed for clinical signs, mortality, until sacrifice. Onset, duration and severity of any sign were recorded. The clinical signs and mortality observations were conducted at 10, 30, 60 minutes, 2, 4 and 6 hours on the day of dosing and once daily thereafter for 14 day. Daily observation was done as far as possible at the same time. The observations included general clinical signs, observations of eyes, mucous membranes, respiratory, circulatory system and behavior pattern.
Evaluation of Dermal Reaction: Dermal reaction was observed daily for study period of 14 days.
Body weights: Individual animal body weights were recorded pre-test (prior to administration of the test item), day 7 and at termination on day 14.
Gross Pathology: Necropsy was performed on animals surviving at the end of the study. Macroscopic examination of all the orifices, cavities and tissues were made and the findings were recorded. All animals surviving the study period were sacrificed by the carbon dioxide asphyxiation technique (day 15).
Histopathology: No gross abnormalities were observed in animals sacrificed terminally hence, no histopathology was performed. - Statistics:
- not specified
- Preliminary study:
- Dose Range Finding Study: In the dose range finding study a single dose of 200 mg/kg body weight of the test item was administered to 1 female animal. No death or clinical signs of toxicity was observed during first 48 hours, hence, additional 1 female animal was administered with the dose of 1000 mg/kg body weight. Administration of 1000 mg/kg body weight revealed no clinical signs of toxicity or mortality during first 48 hours, hence, additional 1 female animal was administered at the dose of 2000 mg/kg body weight.
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 1 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- Dose Range Finding Study:
Group I : Animal treated at the dose level of 200 mg/kg body weight survived through the study period of 14 days.
Group I : Animal treated at the dose level of 1000 mg/kg body weight survived through the study period of 14 days.
Group I : Animal treated at the dose level of 2000 mg/kg body weight found dead on day 1.
Main Study:
Group II : Animals treated at the dose level of 1000 mg/kg body weight survived through the study period of 14 days. - Clinical signs:
- other: Dose Range Finding Study: Group I : Animal treated at the dose level of 200 mg/kg body weight did not result in any signs of toxicity during the study period of 14 days. Group I : Animal treated at the dose level of 1000 mg/kg body weight did not result
- Gross pathology:
- Gross pathological examination did not reveal any abnormalities attributable to the treatment in animals from 200 mg/kg dose group whereas gross pathological examination revealed moderate to severe erythema on site of application in animals from 1000 mg/kg dose group from dose range finding study and main study sacrificed terminally.
- Other findings:
- Evaluation of Dermal Reaction
Dose Range Finding Study:
Group I : Animal treated at the dose level of 200 mg/kg body weight did not result in any skin reaction during the study period of 14 days.
Group I : Animal treated at the dose level of 1000 mg/kg body weight resulted in minimal to moderate erythema at the site of application from day 1 to day 14.
Main Study:
Group II : Animal treated at the dose level of 1000 mg/kg body weight resulted in minimal to moderate erythema at the site of application from day 1 to day 14. - Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- It was concluded that the acute dermal median lethal dose (LD50) of the given test chemical, when administered to female Sprague Dawley rats was considered to be >1000 mg/kg body weight. Thus, according to CLP criteria for acute toxicity rating for the chemicals, it infers that the given test chemical can be classified as an acute dermal toxicant. CLP Classification: “Category 4 (>1000-2000 mg/kg bw)”.
- Executive summary:
The reported study was designed and conducted to determine the acute dermal toxicity profile of the given test chemical as per OECD Guideline 402 (Acute Dermal Toxicity) in Sprague Dawley rats.
In the dose range finding study a single dose of 200 mg/kg body weight of the test item was administered to 1 female animal. No death or clinical signs of toxicity was observed during first 48 hours, hence, additional 1 female animal was administered with the dose of 1000 mg/kg body weight. Administration of 1000 mg/kg body weight revealed no clinical signs of toxicity or mortality during first 48 hours, hence, additional 1 female animal was administered at the dose of 2000 mg/kg body weight.
Administration of 2000 mg/kg body weight resulted in mortality on day 1. As the dose range finding study revealed mortality at the maximum dose of 2000 mg/kg, the main study was initiated with two additional animals at a dose of 1000 mg/kg body weight. The animals were administered with a dose of 1000 mg/kg body weight in sequential manner at 48 hours intervals.
Administration of 200 mg/kg body weight exhibited normal body weight gain and no clinical signs of toxicity during the study period of 14 days. Administration of 1000 mg/kg body weight revealed minimal to moderate erythema at the site of application from day 1 to day 14 and exhibited normal body weight gain, no clinical signs of toxicity or mortality during the study period of 14 days from dose range finding study and main study. Gross pathological examination did not reveal any abnormalities attributable to the treatment in animals from 200 mg/kg dose group whereas gross pathological examination revealed moderate to severe erythema on site of application in animals from 1000 mg/kg dose group.
It was concluded that the acute dermal median lethal dose (LD50) of the given test chemical, when administered to female Sprague Dawley rats was considered to be >1000 mg/kg body weight. Thus, according to CLP criteria for acute toxicity rating for the chemicals, it infers that the given test chemical can be classified as an acute dermal toxicant. CLP Classification: “Category 4 (>1000-2000 mg/kg bw)”.
Reference
Table No. I
Summary of Clinical Signs of Toxicity and Mortality
Laboratory Test Item Code :TAS/122/054
Test System : Sprague Dawley Rat
Sex : Female
Dose Finding Study:
Group No. |
Dose mg/kg |
Observed Signs |
Total Number of Animals |
Animal No. |
Period of signs in days From - to |
Mortality |
I |
200 |
No clinical signs observed |
1 |
1 |
Day 0 - Day 14 |
0/1 |
Group No. |
Dose mg/kg |
Observed Signs |
Total Number of Animals |
Animal No. |
Period of signs in days From - to |
Mortality |
I |
1000 |
No clinical signs observed |
1 |
2 |
Day 0 - Day 14 |
0/1 |
Group No. |
Dose mg/kg |
Observed Signs |
Total Number of Animals |
Animal No. |
Period of signs in days From - to |
Mortality |
I |
2000 |
Found dead |
1 |
3 |
Day 1 |
1/1 |
Main Study:
Group No. |
Dose mg/kg |
Observed Signs |
Total Number of Animals |
Animal Nos. |
Period of signs in days From - to |
Mortality |
II |
1000 |
No clinical signs observed |
2 |
4, 5 |
Day 0 - Day 14 |
0/2 |
Table No. II
Summary of Evaluation of Dermal Reaction
Laboratory Test Item Code :TAS/122/054
Test System : Sprague Dawley Rat
Sex : Female
DoseFinding Study:
Group No. |
Dose mg/kg |
Dermal Reaction |
Total Number of Animals |
Animal No. |
Period of signs in days From - to |
I |
200 |
No dermal reaction observed |
1 |
1 |
Day 0 - Day 14 |
Group No. |
Dose mg/kg |
Dermal Reaction |
Total Number of Animals |
Animal No. |
Period of signs in days From - to |
I |
1000 |
Minimal to moderate erythema |
1 |
2 |
Day 1 - Day 14 |
Main Study:
Group No. |
Dose mg/kg |
Dermal Reaction |
Total Number of Animals |
Animal Nos. |
Period of signs in days From - to |
II |
1000 |
Minimal to moderate erythema |
2 |
4, 5 |
Day 1 – Day 14 |
Table No.III
Mean Body Weight and Percent Body Weight Gain (g)
Laboratory Test Item Code :TAS/122/054
Test System : Sprague Dawley Rat
Sex : Female
DoseFinding Study:
Group No. |
Dose (mg/kg body weight) |
|
Body weight Day 0 |
Body weight Day 7 |
% body weight gain day 0-7 |
Body weight Day 14 |
% body weight gain day 7- 14 |
% body weight gain day 0- 14 |
I |
200 |
Mean |
226.0 |
241.6 |
6.90 |
252.6 |
4.55 |
11.77 |
± SD |
- |
- |
- |
- |
- |
- |
Group No. |
Dose (mg/kg body weight) |
|
Body weight Day 0 |
Body weight Day 7 |
% body weight gain day 0-7 |
Body weight Day 14 |
% body weight gain day 7- 14 |
% body weight gain day 0- 14 |
I |
1000 |
Mean |
235.1 |
248.8 |
5.83 |
257.4 |
3.46 |
9.49 |
± SD |
- |
- |
- |
- |
- |
- |
Group No. |
Dose (mg/kg body weight) |
|
Body weight Day 0 |
Body weight Day 7 |
% body weight gain day 0-7 |
Body weight Day 14 |
% body weight gain day 7- 14 |
% body weight gain day 0- 14 |
I |
2000 |
Mean |
222.8 |
- |
- |
- |
- |
- |
± SD |
- |
- |
- |
- |
- |
- |
Main Study:
Group No. |
Dose (mg/kg body weight) |
|
Body weight Day 0 |
Body weight Day 7 |
% body weight gain day 0-7 |
Body weight Day 14 |
% body weight gain day 7- 14 |
% body weight gain day 0- 14 |
II |
1000 |
Mean |
245.60 |
255.65 |
4.09 |
264.85 |
3.60 |
7.84 |
± SD |
0.14 |
1.34 |
0.61 |
0.78 |
0.24 |
0.38 |
Table No.IV
Summary of Gross Pathological Findings
Laboratory Test Item Code :TAS/122/054
Test System : Sprague Dawley Rat
Sex : Female
DoseFinding Study:
Group No. |
Dose mg/kg |
Animal Number |
Animal Fate |
Gross Pathological Findings |
I |
200 |
1 |
TS |
No abnormality detected |
Group No. |
Dose mg/kg |
Animal Number |
Animal Fate |
Gross Pathological Findings |
I |
1000 |
2 |
TS |
Moderate to severe erythema was observed on site of application |
Group No. |
Dose mg/kg |
Animal Number |
Animal Fate |
Gross Pathological Findings |
I |
2000 |
3 |
FD |
No abnormality detected |
Main Study:
Group No. |
Dose mg/kg |
Animal Numbers |
Animal Fate |
Gross Pathological Findings |
II |
1000 |
4, 5 |
TS |
Moderate to severe erythema was observed on site of application |
FD = Found dead
TS = Terminal sacrifice
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 1 000 mg/kg bw
- Quality of whole database:
- Data is Klimisch 1 and from study report.
Additional information
Acute oral toxicity:
The reported study was designed and conducted 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 Sprague Dawley rats.
Initially, three female animals were treated at the dose level of 300 mg/kg body weight of the test item (Step - I). Administration of the test item at 300 mg/kg resulted in diarrhoea and reduced locomotor activity with onset at 30 minutes to 1 hour after the dosing. Two animals died at 6 hours and one animal died on day 1 after the dosing. As mortality was observed at 300 mg/kg dose group, additional three female animals were treated with the lower dose of 50 mg/kg of the test item (Step - I).
Administration of the test item at 50 mg/kg resulted in diarrhoea with onset at 1 hour after the dosing and no mortality at 24 hours after the dosing. As no mortality was observed at 24 hours after the dosing, three additional female animals were added to the study and treated with the dose of 50 mg/kg of the test item (Step - II). Administration of the test item at 50 mg/kg resulted in diarrhoea with onset at 1 hour after the dosing and no mortality at 24 hours after the dosing.
All animals from 50 mg/kg dose group survived through the study period of 14 days. Gross pathological examination did not reveal any abnormalities in all animals from 300 mg/kg and 50 mg/kg dose groups.
Under the condition of the study, all rats were died at 300 mg/kg bw, hence the LD100 was considered to be 300 mg/kg bw. Considering this value, the LD50 value can be expected to be 200 mg/kg bw. Therefore, comparing this value / range with the criteria of CLP regulation, the given test chemical can be classified in “Category 3 (50 - ≤ 300)” 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 0.0046 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 reported study was designed and conducted to determine the acute dermal toxicity profile of the given test chemical as per OECD Guideline 402 (Acute Dermal Toxicity) in Sprague Dawley rats.
In the dose range finding study a single dose of 200 mg/kg body weight of the test item was administered to 1 female animal. No death or clinical signs of toxicity was observed during first 48 hours, hence, additional 1 female animal was administered with the dose of 1000 mg/kg body weight. Administration of 1000 mg/kg body weight revealed no clinical signs of toxicity or mortality during first 48 hours; hence, additional 1 female animal was administered at the dose of 2000 mg/kg body weight.
Administration of 2000 mg/kg body weight resulted in mortality on day 1. As the dose range finding study revealed mortality at the maximum dose of 2000 mg/kg, the main study was initiated with two additional animals at a dose of 1000 mg/kg body weight. The animals were administered with a dose of 1000 mg/kg body weight in sequential manner at 48 hours intervals.
Administration of 200 mg/kg body weight exhibited normal body weight gain and no clinical signs of toxicity during the study period of 14 days. Administration of 1000 mg/kg body weight revealed minimal to moderate erythema at the site of application from day 1 to day 14 and exhibited normal body weight gain, no clinical signs of toxicity or mortality during the study period of 14 days from dose range finding study and main study. Gross pathological examination did not reveal any abnormalities attributable to the treatment in animals from 200 mg/kg dose group whereas gross pathological examination revealed moderate to severe erythema on site of application in animals from 1000 mg/kg dose group.
It was concluded that the acute dermal median lethal dose (LD50) of the given test chemical, when administered to female Sprague Dawley rats was considered to be >1000 mg/kg body weight. Thus, according to CLP criteria for acute toxicity rating for the chemicals, it infers that the given test chemical can be classified as an acute dermal toxicant. CLP Classification: “Category 4 (1000-2000 mg/kg bw)”.
Justification for classification or non-classification
Based on the above studies on test chemical, it can be concluded that the LD50 value is between 50-300 mg/kg bw, for acute oral toxicity and LD50 value is >1000 mg/kg bw(1000-2000 mg/kg bw), for acute dermal toxicity. Thus, comparing this range and value with the criteria of CLP regulation, the given test chemical can be classified in “Category 3” for acute oral toxicity and “Category 4 (>1000-2000 mg/kg bw)” for acute dermal toxicity. For acute inhalation toxicity wavier was added so, not possible to classify.
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