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EC number: 205-160-7 | CAS number: 134-85-0
- 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 :
Study 1: Based on all the observations and results, the acute oral LD50 (cut-off value) of the test chemical was 5000 mg/kg body weight. Thus, by considering the CLP criteria for acute toxicity rating for the chemicals, it infers that the test chemical does not exhibit acute oral toxicity i.e it is acutely non toxic to animals.
Study 2: Slight lethargy was observed during the course of the study. The LD50 exceeded 5 g/kg based on one (1/10) death at that dose. Thus, based on all the observations and results, it was concluded that the test chemical is not acutely toxic to the rats when administered at 5000 mg/kg bw.
Acute Inhalation Toxicity :
Waiver
Acute Dermal Toxicity :
Study 1: Based on all the available observations and results, it was concluded that, the LD50 was considered to be >2000mg/kg bw, when rats were treated with test chemical by dermal application.
Study 2: Under the conditions of the study, the acute dermal toxicity dose (LD50) was considered to be >2000 mg/kg bw, when rats were treated with the test chemical by dermal application.
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
- Remarks:
- Read across based on grouping of substances (Category approach)
- Adequacy of study:
- weight of evidence
- 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:
- According to OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- no
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Bharat Serum and Vaccines Limited, India.
- Age at study initiation:8- 11 weeks at the time of dosing.
- Health Status :Healthy young adult animals were used for the study. Females were nulliparous and non pregnant.
- Weight at study initiation:Minimum: 181 g and Maximum: 213 g (Individual body weights were within ± 6% prior to treatment after overnight fasting)
- Fasting period:Wistar rats were fasted for 16-18 hrs.
- Housing:The animals were housed individually in polycarbonate cages.
- Bedding:All cages were provided with corn cobs.
- 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.
- Diet (e.g. ad libitum):All animals were provided conventional laboratory rodent diet (Nutrivet Life Sciences, Pune) ad libitum.
- 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 five days and 4-6 for seven days prior to administration of the test item.
ENVIRONMENTAL CONDITIONS
- Temperature (°C):Minimum: 20.40°C and Maximum: 23.10°C
- Humidity (%):Minimum: 38.40 % and Maximum: 58.70 %
- Air changes (per hr):More than 12 changes per hour.
- Photoperiod (hrs dark / hrs light):12:12 - Route of administration:
- oral: unspecified
- Vehicle:
- corn oil
- Details on oral exposure:
- VEHICLE
- Amount of vehicle (if gavage):10 ml
- Justification for choice of vehicle:N/A
- Lot/batch no. (if required):MKBD4650
- Purity:N/A
MAXIMUM DOSE VOLUME APPLIED:10 ml/kg body weight. - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 6 female rats
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:Daily
- Necropsy of survivors performed: yes
At the end of 14 day observation period, all the survived rats were euthanised by overdose of CO2 for external and internal observations.
- 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 the surviving animals were observed once a day during the 14 day observation period.
Body weight
All surviving rats were weighed on days 0 (prior to dosing), 7 and 14. Animals were weighed immediately after found dead.
other:
Mortality
All surviving animals were observed twice daily (morning and evening) for morbidity and mortality, throughout the acclimatization and study period. - Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 5 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: No mortality observed
- Mortality:
- No mortality was observed in the animals treated with 2000 mg/kg dose throught out the 14 days observation period post dosing.
- Clinical signs:
- other: At 2000 mg/kg, animal nos. 1, 2, 3, 5 and 6 were observed normal throughout the experimental period, whereas animal no. 4 was observed normal at 30 minutes, 1, 2, 3 and 4 hours, with mild ataxia from day 1 to 4, with mild tremors on day 1, with mild chrom
- Gross pathology:
- No external and internal gross pathological changes were seen in all the six animals treated with 2000 mg/kg body weight during terminal sacrifice.
- Interpretation of results:
- other: Not Classified
- Conclusions:
- Based on all the observations and results, the acute oral LD50 (cut-off value) of the test chemical was 5000 mg/kg body weight. Thus, by considering the CLP criteria for acute toxicity rating for the chemicals, it infers that the test chemical does not exhibit acute oral toxicity i.e it is acutely non toxic to animals.
- Executive summary:
An Acute Oral Toxicity Study of the test chemical in Rats, was conducted. This study was performed as per OECD No. 423. Six female Wistar rats were selected for acute oral toxicity study. The animals were fasted for minimum 16-18 hours prior to dosing and for 3-4 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 first group were dosed with starting dose of 2000 mg/kg body weight and the animals did not show any mortality so another three animals of the same group were dosed with 2000 mg/kg body weight and no mortality was observed. Hence, further dosing was stopped. Body weights were recorded on day 0 (prior to dosing) 7 and 14. Body weight gain was observed in all the animals treated with 2000 mg/kg body weight, during the 14 day observation period, as compared to day 0. At 2000 mg/kg, animal nos. 1, 2, 3, 5 and 6 were observed normal throughout the experimental period, whereas animal no. 4 was observed normal at 30 minutes, 1, 2, 3 and 4 hours, with mild ataxia from day 1 to 4, with mild tremors on day 1, with mild chromodacryorrhea from day 2 to 6 and with moderate to mild lethargy from day 3 to 9 post dosing followed by normal observation till day 14. No external and internal gross pathological changes were seen in all the six animals treated with 2000 mg/kg body weight during terminal sacrifice. Based on all the observations and results, the acute oral LD50 (cut-off value) of the test chemical was 5000 mg/kg body weight. Thus, by considering the CLP criteria for acute toxicity rating for the chemicals, it infers that the test chemical does not exhibit acute oral toxicity i.e it is acutely non toxic to animals.
Reference
Table 1: Individual Animal Body Weight (g) andBody 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 |
213 |
233 |
247 |
9.39 |
15.96 |
2 |
200 |
227 |
240 |
13.50 |
20.00 |
|
3 |
189 |
221 |
252 |
16.93 |
33.33 |
|
4 |
194 |
173 |
205 |
-10.82 |
5.67 |
|
5 |
186 |
203 |
209 |
9.14 |
12.37 |
|
6 |
181 |
195 |
196 |
7.73 |
8.29 |
Table 2: Summary of Animal Body Weight (g) and Body Weight Changes (%)
Sex:Female
Group/ Dose (mg/kg) |
Rats Body Weight (g) |
Body Weight Changes (%) |
||||
Day 0 |
Day 7 |
Day 14 |
0-7 |
0-14 |
||
G1/ 2000 |
Mean |
193.83 |
208.67 |
224.83 |
7.65 |
15.94 |
SD |
11.44 |
22.68 |
24.23 |
9.66 |
9.96 |
|
n |
6 |
6 |
6 |
6 |
6 |
Keys:SD = Standard Deviation, n = Number of Animals
Table 3: Individual Animal Clinical Signs and Symptoms
Sex:Female
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 |
21+ 166+ |
21+ 32++ |
21+ 32+ 99++ |
21+ 99+ 32+ |
32+ 99++ |
32+ 99++ |
99++ |
99+ |
99+ |
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, 21 = Ataxia, 32 = Chromodacryorrhea, 99 = Lethargy, 166 = Tremors, + = Mild, ++ = Moderate
Table 4: Individual Animal Mortality Record
Sex:Female
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
Sex:Female
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:
- > 5 000 mg/kg bw
- Quality of whole database:
- K1
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- the study does not need to be conducted because exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size
Reference
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Remarks:
- read-across from supporting subsatnce (surrogate)
- Adequacy of study:
- weight of evidence
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- Read across data from a study report.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Principles of method if other than guideline:
- According to OECD Guideline 402 (Acute Dermal Toxicity)
- 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 Animals.
- Age at study initiation: N/A
- Health Status:Healthy young adult animals were used for the study. Females were nulliparous and non pregnant.
- Weight (Prior to Treatment):Male:Minimum: 247 g and Maximum: 251 g ,Female:Minimum: 247 g and Maximum: 260 g
- Fasting period before study: N/A
- Housing:The animals were housed individually in polycarbonate cages.
- Bedding : All cages were provided with corn cobs.
- 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.
- Diet (e.g. ad libitum):All animals were provided conventional laboratory rodent diet (Nutrivet Life Sciences, Pune) ad libitum.
- 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 5 days prior to administration of the test item.
- Randomization : Animals were selected manually. No computer generated randomization program was used.
ENVIRONMENTAL CONDITIONS
- Temperature (°C):Minimum: 20.40 °C and Maximum: 23.10 °C
- Humidity (%):Minimum: 38.40% and Maximum: 58.70%
- Air changes (per hr):More than 12 changes per hour
- Photoperiod (hrs dark / hrs light):12:12
- IN-LIFE DATES: From: January 30, 2014 to: March, 2014 - Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure:The test item was applied uniformly over clipped dorsal area of rat skin.
- % coverage:Approximately 10% body surface area of rat.
- Type of wrap if used:The porous gauze dressing and non-irritating tape.
REMOVAL OF TEST SUBSTANCE
- Washing (if done):The residual test item was removed by using distilled water.
- Time after start of exposure:24-hour.
TEST MATERIAL
- Amount(s) applied (volume or weight with unit):A limit dose of 2000 mg/ kg body weight of test item was applied.
- Constant volume or concentration used: yes
- For solids, paste formed: no
VEHICLE
- Amount(s) applied (volume or weight with unit):N/A
- Concentration (if solution):N/A
- Lot/batch no. (if required):N/A
- Purity:N/A - Duration of exposure:
- 24 hrs
- Doses:
- 2000 mg/kg body weight.
- No. of animals per sex per dose:
- 10 (Five per sex)
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:Daily
- Necropsy of survivors performed: yes
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.
- Other examinations performed:
- Clinical signs : 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.
- Body weight: All rats were weighed on days 0 (prior to dosing), 7 and 14.
other:
- Local Signs/Skin Reactions
All animals were observed once daily during days 1-14 (in common with clinical signs).
- Mortality
Animals were observed twice daily for any mortality during the experimental period. - Statistics:
- No statistical analysis was performed since the study was terminated with limit test.
- Preliminary study:
- No data available
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: No mortality was observed
- Mortality:
- No mortality was observed at limit dose of 2000 mg/kg body weight of test item during the 14 day observation period.
- Clinical signs:
- other: No systemic or local signs of toxicity were observed at limit dose of 2000 mg/kg body weight of test item during the experimental period.
- Gross pathology:
- The external and internal gross pathological observation of all terminally sacrificed animals did not show any pathological abnormality.
- Other findings:
- No data available
- Interpretation of results:
- other: Not classified
- Conclusions:
- Based on all the available observations and results, it was concluded that, the LD50 was considered to be >2000mg/kg bw, when rats were treated with test chemical by dermal application.
- Executive summary:
An Acute Dermal Toxicity Study was conducted using test chemical as per OECD No.402 in 10 male and female healthy young adult Wistar rats which were randomly selected and used for conducting acute dermal toxicity study at the concentration of 2000 mg/kg bw. Rats free from injury and irritation of skin were selected for the study. 24 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 was applied by single dermal application and observed for 14 days after treatment. On test day 0,as such amount of test item, calculated based on density (1.0016) and body weight was applied directly on the intact skin of clipped area of rats; the surgical gauze patch was put on to the intact skin of clipped area. This porous gauze dressing was covered with a non-irritating adhesive tape. The porous gauze dressing was wrapped around the abdomen and anchored with non-irritating adhesive 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 recorded 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. No clinical signs and any skin reaction were observed throughout the experimental period in all treated animals. The male and female animals were observed with body weight gain throughout the experiment, except on day 7 male animals were observed with decline in mean body weight gain as compared to day 0. The external and internal gross pathological observation of all terminally sacrificed animals did not show any pathological abnormality. Hence the LD50 was considered to be >2000mg/kg bw, when rats were treated with test chemical by dermal application.
Reference
Table 1: Individual Animal Body Weight (g) andBody Weight Changes(%)
Dose:2000 mg/ kg bodyweight Density:1.0016
Animal No. |
Sex |
Dose (ml) Applied* |
Body Weight (gram) |
Body Weight Change (%) |
|||
Day 0 |
Day 7 |
Day 14 |
Day 0-7 |
Day 0-14 |
|||
1 |
Male |
0.50 |
250 |
238 |
260 |
-4.80 |
4.00 |
2 |
0.49 |
247 |
227 |
245 |
-8.10 |
-0.81 |
|
3 |
0.50 |
250 |
243 |
272 |
-2.80 |
8.80 |
|
4 |
0.50 |
249 |
244 |
256 |
-2.01 |
2.81 |
|
5 |
0.50 |
251 |
256 |
271 |
1.99 |
7.97 |
|
6 |
Female |
0.51 |
253 |
259 |
258 |
2.37 |
1.98 |
7 |
0.50 |
249 |
251 |
255 |
0.80 |
2.41 |
|
8 |
0.50 |
250 |
248 |
260 |
-0.80 |
4.00 |
|
9 |
0.52 |
260 |
267 |
270 |
2.69 |
3.85 |
|
10 |
0.49 |
247 |
254 |
255 |
2.83 |
3.24 |
Key:* = Based on density of test item and day 0 body weight taken prior to dose application.
Table 2: Individual Animal Clinical Signs and Symptoms
Dose:2000 mg/kg body weight
Animal No. |
Sex |
Hour(s) - Day 0 |
Day |
||||||||||||||||
1 |
2 |
3 |
4 |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
||
1 |
Male |
1 |
1 |
1 |
1 |
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 |
1 |
1 |
1 |
1 |
|
3 |
1 |
1 |
1 |
1 |
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 |
1 |
1 |
1 |
1 |
|
5 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
|
6 |
Female |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
7 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
|
8 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
|
9 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
|
10 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
Key: 1 = Normal
Table 3: Individual Animal Mortality Record
Dose:2000 mg/kg body weight
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 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- > 2 000 mg/kg bw
- Quality of whole database:
- K1
Additional information
Acute Oral Toxicity :
Study 1: An Acute Oral Toxicity Study of the test chemical in Rats, was conducted. This study was performed as per OECD No. 423. Six female Wistar rats were selected for acute oral toxicity study. The animals were fasted for minimum 16-18 hours prior to dosing and for 3-4 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 first group were dosed with starting dose of 2000 mg/kg body weight and the animals did not show any mortality so another three animals of the same group were dosed with 2000 mg/kg body weight and no mortality was observed. Hence, further dosing was stopped. Body weights were recorded on day 0 (prior to dosing) 7 and 14. Body weight gain was observed in all the animals treated with 2000 mg/kg body weight, during the 14 day observation period, as compared to day 0. At 2000 mg/kg, animal nos. 1, 2, 3, 5 and 6 were observed normal throughout the experimental period, whereas animal no. 4 was observed normal at 30 minutes, 1, 2, 3 and 4 hours, with mild ataxia from day 1 to 4, with mild tremors on day 1, with mild chromodacryorrhea from day 2 to 6 and with moderate to mild lethargy from day 3 to 9 post dosing followed by normal observation till day 14. No external and internal gross pathological changes were seen in all the six animals treated with 2000 mg/kg body weight during terminal sacrifice. Based on all the observations and results, the acute oral LD50 (cut-off value) of the test chemical was 5000 mg/kg body weight. Thus, by considering the CLP criteria for acute toxicity rating for the chemicals, it infers that the test chemical does not exhibit acute oral toxicity i.e it is acutely non toxic to animals.
Study 2 : In an acute oral toxicity study, the acute oral LD50 of the test chemical was determined in 10 rats. The rats were observed for mortality and/or systemic effects for 14 days. Slight lethargy was observed during the course of the study. The LD50 exceeded 5 g/kg based on one (1/10) death at that dose. Thus, based on all the observations and results, it was concluded that the test chemical is not acutely toxic to the rats when administered at 5000 mg/kg bw.
Acute Inhalation Toxicity :
Waiver
Acute Dermal Toxicity :
Study 1:
An Acute Dermal Toxicity Study was conducted using test chemical as per OECD No.402 in 10 male and female healthy young adult Wistar rats which were randomly selected and used for conducting acute dermal toxicity study at the concentration of 2000 mg/kg bw. Rats free from injury and irritation of skin were selected for the study. 24 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 was applied by single dermal application and observed for 14 days after treatment. On test day 0,as such amount of test item, calculated based on density (1.0016) and body weight was applied directly on the intact skin of clipped area of rats; the surgical gauze patch was put on to the intact skin of clipped area. This porous gauze dressing was covered with a non-irritating adhesive tape. The porous gauze dressing was wrapped around the abdomen and anchored with non-irritating adhesive 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 recorded 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. No clinical signs and any skin reaction were observed throughout the experimental period in all treated animals. The male and female animals were observed with body weight gain throughout the experiment, except on day 7 male animals were observed with decline in mean body weight gain as compared to day 0. The external and internal gross pathological observation of all terminally sacrificed animals did not show any pathological abnormality. Hence the LD50 was considered to be >2000mg/kg bw, when rats were treated with test chemical by dermal application.
Study 2: Acute dermal toxicity study for the test chemical was conducted as per OECD No. 402 in Wistar Rats. Five male and five female healthy young adult rats were randomly selected and used for conducting acute dermal toxicity study. Rats free from injury and irritation of skin were selected for the study. Approximately, twenty four hours prior to dermal application of test item, greater than 10% of body surface area of each rat was clipped. A limit dose of 2000 mg/ kg body weight based on the test item density (1.07513) and latest body weight was applied by single dermal application and observed for 14 days after treatment. On test day 0, calculated volume 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 and post dosing till the termination. 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. At 2000 mg/kg, all the animals were observed normal throughout the experimental period. Mean body weight was observed with gain on day 7 and 14 of male and female animals, as compared to day 0. The external and internal gross pathological observation of all terminally sacrificed animals did not show any pathological abnormality. Under the conditions of the study, the acute dermal toxicity dose (LD50) was considered to be >2000 mg/kg bw, when rats were treated with the test chemical by dermal application.
Justification for classification or non-classification
Based on the available study data of the read across chemical substance it was observed that the LD50 value for oral toxicity study was >5000 mg/kg whereas,for Dermal toxicity study it was found to be >2000 mg/kg thus it was concluded that the test chemical was not classified as per CLP criteria.
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