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EC number: 203-973-1 | CAS number: 112-45-8
- 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
Endpoint summary
Administrative data
Description of key information
Acute oral toxicity:
The acute oral toxicity dose (LD50) was considered based on study conducted 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 0.060 mmHg. 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 study conducted on rats for the test chemical. The studies concluded that the 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
- 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 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 aim of this study was to assess the toxicity potential of test chemical after single oral administration in rats and 14 day observation period
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: In-House Bred at Sa-FORD, Animal Facility
- Health Status : Healthy young adult animals were used for the study. Females were nulliparous and non pregnant.
- Age at study initiation: 8- 10 weeks at the time of dosing
- Weight at study initiation: Minimum: 136 g and Maximum: 156 g (Individual body weights were within ± 5% prior to treatment after overnight fasting)
- Fasting period before study: Overnight
- Housing: The animals were housed individually in polycarbonate cages and
- Bedding: All cages were provided with corn cobs
- Diet (e.g. ad libitum): All animals were provided conventional laboratory rodent diet (Nutrivet Life Sciences, Pune) ad libitum. Batch No 400004
- Water (e.g. ad libitum): Aqua guard filtered tap water was provided ad libitum via drinking bottles
- Acclimation period: Animal nos. 1-3 were acclimatized for 6 days and 4-6 for 9 days prior to administration of the test item
- Identification : The animals were marked temporarily on tail, permanently on toe pad micro tattooing and cage cards. Individual cage cards were labelled with study no., study type, test system, group, dose, sex, animal number, experimental start and completion date
- Room Sanitation: The experimental room floor and work tops were swept and mopped with disinfectant solution every day.
- Cages and water bottle: All the cages and water bottles were changed at least twice every week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Minimum: 19.80°C andMaximum: 23.20°C
- Humidity (%): Minimum: 48.60 % and Maximum: 63.20 %
- Air changes (per hr): More than 12 changes per hour
- Photoperiod (hrs dark / hrs light): 12:12 - Route of administration:
- oral: drinking water
- Vehicle:
- corn oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 2000 mg/Kg bw
- Amount of vehicle (if gavage): The maximum dose volume administered was 10 ml/kg body weight.
- Justification for choice of vehicle: Corn oil was selected as a vehicle because test item was not miscible in the distilled water during solubility testing
- Lot/batch no. (if required):
- Purity:
DOSAGE PREPARATION:
Added slowly vehicle in to the test item and mixed well. Transferred the formulation to the measuring cylinder and made the volume up to desired quantity. The dosing solution was prepared freshly, shortly prior to dose administration
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: - Doses:
- 2000 mg/kg body weight
- No. of animals per sex per dose:
- 6
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: After test item administration, individual animals were frequently observed at 30 minutes, 1, 2, 3 and 4 hours post dosing on day 0 (day of dosing). Subsequently, all animals were observed once a day during the 14 day observation period. All rats were weighed on days 0 (prior to dosing), 7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed:
Clinical Observation
After test item administration, individual animals were frequently observed at 30 minutes, 1, 2, 3 and 4 hours post dosing on day 0 (day of dosing). Subsequently, all animals were observed once a day during the 14 day observation period.
Mortality
All animals were observed twice daily (morning and evening) for morbidity and mortality, throughout the acclimatization and study period.
Body weight
All rats were weighed on days 0 (prior to dosing), 7 and 14.
Pathology
At the end of 14 day observation period, all rats were euthanised by overdose of CO2 for external and internal observations. - Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 5 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other:
- Remarks:
- No mortality observed
- Mortality:
- No mortality was observed througout the experimentation period. (refer table 4).
- Clinical signs:
- other: At 2000mg/kg, all the six animals were observed with normal clinical sign till day 14 (refer table 3).
- Gross pathology:
- No external and internal gross pathological examination were seen in all the six animals treated with 2000 mg/kg body weight during terminal sacrifice (refer table 5).
- Interpretation of results:
- other: Not classified
- Conclusions:
- Acute oral toxicity study of teswt chemical in female rats is as given below:
The acute oral LD50 was 5000 mg/kg body weight.Test chemical is being classified as non toxic by oral administration - Executive summary:
Acute oral toxicity study was conducted for the test compound in female Wistar rats as per OECD No. 423. The animals were fasted for minimum 16-18 hours prior to dosing and for 4 hours post dosing, with food withheld but drinking water provided ad libitum. The time intervals between dosing were determined by the onset, duration and severity of toxic signs. Three rats of group G1 were dosed with starting dose of 2000 mg/kg body weight and the animals showed no mortality post dosing, so another three rats of the same group were dosed with 2000 mg/kg weight and no mortality was observed. Hence, further dosing was stopped. Body weights were recorded on day 0 (prior to dosing), 7 and 14. Mean body weight of animals treated with 2000 mg/kg body weight was observed with gain on day 7 and 14, as compared to day 0. At 2000mg/kg, all the six animals were observed with normal clinical sign till day 14. No external and internal gross pathological examination were seen in all the six animals treated with 2000 mg/kg body weight during terminal sacrifice.The acute oral LD50of test chemical was5000 mg/kgbody weight.
Reference
Table 1: Individual Animal Body Weight (g) and Body Weight Changes(%)
Sex:Female
Animal No. |
Group/ Dose (mg/kg) |
Body Weight (gram) |
Body Weight Change (%) |
|||
Day 0 |
Day 7 |
Day 14 |
Day 0-7 |
Day 0-14 |
||
1 |
G1/ 2000 |
153 |
186 |
202 |
21.57 |
32.03 |
2 |
136 |
169 |
179 |
24.26 |
31.62 |
|
3 |
145 |
171 |
189 |
17.93 |
30.34 |
|
4 |
156 |
190 |
193 |
21.79 |
23.72 |
|
5 |
146 |
178 |
186 |
21.92 |
27.40 |
|
6 |
154 |
187 |
200 |
21.43 |
29.87 |
Table 2: Summary of Animal Body Weight (g) and Body Weight Changes (%)
Group/ Dose (mg/kg) |
Rats Body Weight (g) |
Body Weight Changes (%) |
||||
Day 0 |
Day 7 |
Day 14 |
0-7 |
0-14 |
||
G1/ 2000 |
Mean |
148.33 |
180.17 |
191.50 |
21.48 |
29.16 |
SD |
7.50 |
8.84 |
8.69 |
2.03 |
3.13 |
|
n |
6 |
6 |
6 |
6 |
6 |
Keys:SD = Standard Deviation, n = Number of Animals.
Table 3: Individual Animal Clinical Signs and Symptoms
Animal No. |
Group/ Dose (mg/kg) |
Hours (Day 0) |
||||
1/2 |
1 |
2 |
3 |
4 |
||
1 |
G1/ 2000 |
1 |
1 |
1 |
1 |
1 |
2 |
1 |
1 |
1 |
1 |
1 |
|
3 |
1 |
1 |
1 |
1 |
1 |
|
4 |
1 |
1 |
1 |
1 |
1 |
|
5 |
1 |
1 |
1 |
1 |
1 |
|
6 |
1 |
1 |
1 |
1 |
1 |
Animal No. |
Group/ Dose (mg/kg) |
Days post dosing |
|||||||||||||
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
||
1 |
G1/ 2000 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
2 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
|
3 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
|
4 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
|
5 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
|
6 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
Keys: 1 = Normal
Table 4: Individual Animal Mortality Record
Animal No. |
Group/ Dose (mg/kg) |
Day of Observation (Day 0 to 14) |
|
Morning Observations |
Evening Observations |
||
1 |
G1/ 2000 |
No mortality and morbidity |
No mortality and morbidity |
2 |
No mortality and morbidity |
No mortality and morbidity |
|
3 |
No mortality and morbidity |
No mortality and morbidity |
|
4 |
No mortality and morbidity |
No mortality and morbidity |
|
5 |
No mortality and morbidity |
No mortality and morbidity |
|
6 |
No mortality and morbidity |
No mortality and morbidity |
Table 5: Gross Necropsy Observation
Animal No. |
Group/ Dose (mg/kg) |
Mode of Death |
Gross Observation |
|
External |
Internal |
|||
1 |
G1/ 2000 |
Terminal sacrifice |
No abnormality detected |
No abnormality detected |
2 |
Terminal sacrifice |
No abnormality detected |
No abnormality detected |
|
3 |
Terminal sacrifice |
No abnormality detected |
No abnormality detected |
|
4 |
Terminal sacrifice |
No abnormality detected |
No abnormality detected |
|
5 |
Terminal sacrifice |
No abnormality detected |
No abnormality detected |
|
6 |
Terminal sacrifice |
No abnormality detected |
No abnormality detected |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 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:
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 study report
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Principles of method if other than guideline:
- The objective of the study was to assess the dermal toxicity of test chemical after single dose application by dermal route in rats and an observation period of 14 days
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: In-House Bred at Sa-Ford, Animal Facility
- Health Status : Healthy young adult animals were used for the study. Females were nulliparous and non pregnant
- Weight at study initiation: Male: Minimum: 239 g and Maximum: 261 g and Female: Minimum: 207 g and Maximum: 229 g
- Housing: The animals were housed individually in polycarbonate cages
- Bedding: All cages were provided with corn cobs (Sparconn Life Sciences Bangalore) Batch No.: SPAR – 25/2014
- Diet (e.g. ad libitum): All animals were provided conventional laboratory rodent diet (Nutrivet Life Sciences, Pune) ad libitum. Batch No 400004.
- Water (e.g. ad libitum): Aqua guard filtered tap water was provided ad libitum via drinking bottles.
- Acclimation period: All animals were acclimatized to the test conditions for 6 days prior to administration of the test item
- Room Sanitation: The experimental room floor and work tops were swept and mopped with disinfectant solution every day.
- Cages and water bottle: All the cages and water bottles were changed at least twice every week.
- Randomization: Animals were selected manually. No computer generated randomization program was used
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Minimum: 19.80 °C and Maximum: 23.20 °C
- Humidity (%): Minimum: 48.60% and Maximum: 61.10%
- Air changes (per hr): More than 12 changes per hour
- Photoperiod (hrs dark / hrs light): 12:12 - Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: dorsal area of the trunk
- % coverage: approximately 10% body surface area
- Type of wrap if used: porous gauze dressing (Approx. 10% of body surface area of rat) and non-irritating tape
REMOVAL OF TEST SUBSTANCE
- Washing (if done): At the end of the exposure period, residual test item was removed by using distilled water.
- Time after start of exposure: 24 hr
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): Individual rat was applied with an amount of test item, calculated based on the density (0.8417) and latest body weight
- Concentration (if solution): not applicable
- Constant volume or concentration used: yes
VEHICLE: Not applicable - Duration of exposure:
- 24 hr
- Doses:
- 2000 mg/kg body weight
- No. of animals per sex per dose:
- Total: 10
2000 mg/Kg bw: 5/sex/dose - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: After test item administration, individual animals were frequently observed at 1, 2, 3 and 4 hours post dosing on day 0 (day of dosing). Subsequently, all animals were observed once a day during the 14 day observation period.
All rats were weighed on days 0 (prior to dosing), 7 and 14
- Necropsy of survivors performed: yes
- Other examinations performed:
Clinical Observation
After test item administration, individual animals were frequently observed at 1, 2, 3 and 4 hours post dosing on day 0 (day of dosing). Subsequently, all animals were observed once a day during the 14 day observation period.
Mortality
Animals were observed twice daily for any mortality during the experimental period.
Body weight
All rats were weighed on days 0 (prior to dosing), 7 and 14.
Local Signs/Skin Reactions
All animals were observed once daily during days 1-14 (in common with clinical signs).
Pathology
At the end of 14 day observation period, all the surviving rats were euthanised by overdose of CO2 and subjected to gross pathology examination, for external and internal observations - Statistics:
- No statistical analysis was performed since the study was terminated with limit test.
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other:
- Remarks:
- No mortality observed
- Mortality:
- No mortality was observed at limit dose of 2000 mg/kg body weight of test item during the 14 day observation period (refer table 3).
- Clinical signs:
- other: All the animals were observed with normal clinical signs throughout the experimental period (refer table 2).
- Gross pathology:
- The external and internal gross pathological observation of all terminally sacrificed animals did not show any pathological abnormality (refer table 5).
- Interpretation of results:
- other: Not classified
- Conclusions:
- The acute dermal median lethal dose of test chemical was > 2000 mg/kg body weight. Test chemical is being classified as non toxic by dermal exposure.
- Executive summary:
Acute Dermal Toxicity Study of test chemical was performed inWistar Rats as per OECD No.402. Five male and five female healthy young adult rats were randomly selected and used for conducting acute dermal toxicity study. Ratsfree from injury and irritation of skin were selected for the study. Twenty four hours prior to dermal application of test item, approximately 10% of body surface area of each rat was clipped. A limit dose of 2000 mg/ kg body weight of test item based on the density (0.8417) and latest body weight was applied by single dermal application and observed for 14 days after treatment. On test day 0, calculated amount of test item was applied directly on the intact skin of clipped area of rats; the porous gauze dressing was put on to the intact skin of clipped area. This porous gauze dressing was covered with a non-irritating tape. After the 24-hour application period, the dressings were removed and the skin was gently wiped with distilled water. The skin reactions were assessed. The animals were observed daily for mortality and clinical signs, during the acclimatization period. All animals were observed for clinical signs at approximately 1, 2, 3 and 4 hours after treatment on day 0 and once daily during test days 1-14. Mortality was recorded after application on test day 0 and twice daily during days 1-14 (at least once on the day of sacrifice). Local signs / Skin reactions were observed daily from test days 1-14 (in common with clinical signs). Body weights were re¬corded on day 0 (prior to application) and on day 7 and 14. All animals were necropsied and examined macroscopically. No mortality was observed in any animal till the end of the experimental period. All the animals were observed with normal clinical signs throughout the experimental period. Mean body weight of both males and females were observed with increase on day 7 and 14, as compared to day 0. The external and internal gross pathological observation of all terminally sacrificed animals did not show any pathological abnormality. The acute dermal median lethal dose of test chemical was found to be > 2000 mg/kg bw.
Reference
Table 1: Individual Animal Body Weight (g) andBody Weight Changes(%)
Dose:2000 mg/ kg bodyweight Density:0.8417
Animal No. |
Sex |
Dose Volume* (ml) |
Body Weight (gram) |
Body Weight Change (%) |
|||
Day 0 |
Day 7 |
Day 14 |
Day 0-7 |
Day 0-14 |
|||
1 |
Male |
0.60 |
253 |
271 |
314 |
7.11 |
24.11 |
2 |
0.62 |
261 |
280 |
319 |
7.28 |
22.22 |
|
3 |
0.60 |
254 |
280 |
310 |
10.24 |
22.05 |
|
4 |
0.61 |
256 |
272 |
312 |
6.25 |
21.88 |
|
5 |
0.57 |
239 |
247 |
281 |
3.35 |
17.57 |
|
6 |
Female |
0.49 |
207 |
206 |
217 |
-0.48 |
4.83 |
7 |
0.52 |
219 |
218 |
226 |
-0.46 |
3.20 |
|
8 |
0.50 |
212 |
221 |
226 |
4.25 |
6.60 |
|
9 |
0.54 |
226 |
221 |
234 |
-2.21 |
3.54 |
|
10 |
0.54 |
229 |
236 |
251 |
3.06 |
9.61 |
Key:* = based on density and day 0 body weight
Table 2: Individual Animal Clinical Signs and Symptoms
Animal No. |
Sex |
Hour(s) - Day 0 |
Day |
|||||||||
1 |
2 |
3 |
4 |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
||
1 |
Male |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
2 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
|
3 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
|
4 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
|
5 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
|
6 |
Female |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
7 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
|
8 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
|
9 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
|
10 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
Animal No. |
Sex |
Day |
||||||
8 |
9 |
10 |
11 |
12 |
13 |
14 |
||
1 |
Male |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
2 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
|
3 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
|
4 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
|
5 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
|
6 |
Female |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
7 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
|
8 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
|
9 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
|
10 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
Keys: 1 = Normal
Table 3: Individual Animal Mortality Record
Animal No. |
Sex |
Days of Observation (0 to 14) |
|
Morning Observations |
Evening Observations |
||
1 |
Male |
No mortality and morbidity |
No mortality and morbidity |
2 |
No mortality and morbidity |
No mortality and morbidity |
|
3 |
No mortality and morbidity |
No mortality and morbidity |
|
4 |
No mortality and morbidity |
No mortality and morbidity |
|
5 |
No mortality and morbidity |
No mortality and morbidity |
|
6 |
Female |
No mortality and morbidity |
No mortality and morbidity |
7 |
No mortality and morbidity |
No mortality and morbidity |
|
8 |
No mortality and morbidity |
No mortality and morbidity |
|
9 |
No mortality and morbidity |
No mortality and morbidity |
|
10 |
No mortality and morbidity |
No mortality and morbidity |
Table 4:Summary of Animal Body Weight (g) and Body Weight Changes (%)
Sex |
Body Weight (gram) |
Body Weight Changes (%) |
||||
Day 0 |
Day 7 |
Day 14 |
Day 0-7 |
Day 0-14 |
||
Male |
Mean |
252.60 |
270.00 |
307.20 |
6.85 |
21.57 |
SD |
8.20 |
13.55 |
15.02 |
2.47 |
2.41 |
|
n |
5 |
5 |
5 |
5 |
5 |
|
Female |
Mean |
218.60 |
220.40 |
230.80 |
0.83 |
5.56 |
SD |
9.24 |
10.69 |
12.79 |
2.70 |
2.63 |
|
n |
5 |
5 |
5 |
5 |
5 |
Keys: SD= Standard deviation, n = Number of animals
Table 5: Gross Necropsy Observation
Mode of Death:Terminal Sacrifice
Animal No. |
Sex |
Gross Observation |
|
External |
Internal |
||
1 |
Male |
No abnormalities detected |
No abnormalities detected |
2 |
No abnormalities detected |
No abnormalities detected |
|
3 |
No abnormalities detected |
No abnormalities detected |
|
4 |
No abnormalities detected |
No abnormalities detected |
|
5 |
No abnormalities detected |
No abnormalities detected |
|
6 |
Female |
No abnormalities detected |
No abnormalities detected |
7 |
No abnormalities detected |
No abnormalities detected |
|
8 |
No abnormalities detected |
No abnormalities detected |
|
9 |
No abnormalities detected |
No abnormalities detected |
|
10 |
No abnormalities detected |
No abnormalities detected |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- Data is Klimisch 1 and from study report
Additional information
Acute oral toxicity:
In different experimental studies, 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 –
1.Acute oral toxicity study was conducted for the test compound in female Wistar ratsas per OECD No. 423. The animals were fasted for minimum 16-18 hours prior to dosing and for 4 hours post dosing, with food withheld but drinking water provided ad libitum. The time intervals between dosing were determined by the onset, duration and severity of toxic signs. Three rats of group G1 were dosed with starting dose of 2000 mg/kg body weight and the animals showed no mortality post dosing, so another three rats of the same group were dosed with 2000 mg/kg weight and no mortality was observed. Hence, further dosing was stopped. Body weights were recorded on day 0 (prior to dosing), 7 and 14. Mean body weight of animals treated with 2000 mg/kg body weight was observed with gain on day 7 and 14, as compared to day 0. At 2000mg/kg, all the six animals were observed with normal clinical sign till day 14. No external and internal gross pathological examination were seen in all the six animals treated with 2000 mg/kg body weight during terminal sacrifice.The acute oral LD50of test chemical was5000 mg/kgbody weight.
2. Acute oral toxic nature of the test compound was evaluated using rats. The dosing was done by the oral route and mortality was observed.The acute oral median LD50of test chemical was found to be > 5000 mg/Kg bw and hence non toxic by the oral route.
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, 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 0.060 mmHg. Thus, exposure to inhalable dust, mist and vapour of the chemical is highly unlikely. Therefore this study is considered for waiver.
Acute Dermal Toxicity:
In an experimental study 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 along with the studies available. The studies are summarized as below -
1.Acute Dermal Toxicity Study of test chemical was performed inWistar Rats as per OECD No.402. Five male and five female healthy young adult rats were randomly selected and used for conducting acute dermal toxicity study. Ratsfree from injury and irritation of skin were selected for the study. Twenty four hours prior to dermal application of test item, approximately 10% of body surface area of each rat was clipped. A limit dose of 2000 mg/ kg body weight of test item based on the density (0.8417) and latest body weight was applied by single dermal application and observed for 14 days after treatment. On test day 0, calculated amount of test item was applied directly on the intact skin of clipped area of rats; the porous gauze dressing was put on to the intact skin of clipped area. This porous gauze dressing was covered with a non-irritating tape. After the 24-hour application period, the dressings were removed and the skin was gently wiped with distilled water. The skin reactions were assessed. The animals were observed daily for mortality and clinical signs, during the acclimatization period. All animals were observed for clinical signs at approximately 1, 2, 3 and 4 hours after treatment on day 0 and once daily during test days 1-14. Mortality was recorded after application on test day 0 and twice daily during days 1-14 (at least once on the day of sacrifice). Local signs / Skin reactions were observed daily from test days 1-14 (in common with clinical signs). Body weights were re¬corded on day 0 (prior to application) and on day 7 and 14. All animals were necropsied and examined macroscopically. No mortality was observed in any animal till the end of the experimental period. All the animals were observed with normal clinical signs throughout the experimental period. Mean body weight of both males and females were observed with increase on day 7 and 14, as compared to day 0. The external and internal gross pathological observation of all terminally sacrificed animals did not show any pathological abnormality. The acute dermal median lethal dose of test chemical was found to be > 2000 mg/kg bw.
2.Acute dermal toxic nature of the test compound was assessed in rabbits. The test chemical was applied at a dose of 5000 mg/Kg bw. No mortality was noted at the tested concentration. The acute dermal median lethal dose (LD50) for the test compound was found to be >5000 mg/Kg bw. Test chemical does not exhibit acute toxicity by the dermal route with the dose mentioned in the study.
Thus, based on the above summarised study 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, 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.
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