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EC number: 271-524-7 | CAS number: 68583-95-9 This substance is identified in the Colour Index by Colour Index Constitution Number, C.I. 16035:1.
- 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
A study was designed and conducted to determine the acute oral toxicity profile of the test chemical in Sprague Dawley rats.12 female, nulliparous and non-pregnant Sprague Dawley rats were used for the study.
It was concluded that the acute oral median lethal dose (LD50) of the test chemical when administered to Sprague Dawley rats was considered to be greater than 2000 mg/kg body weight. Thus by considering the CLP criteria for acute toxicity rating for the chemicals, it can be inferred that the test chemical does not exhibit acute toxicity by the oral route and can be considered as “Not Classified”.
Acute Inhalation
The study need not be performed because exposure to humans via inhalation route is not likely taking into account the low vapour pressure of the test chemical [The estimated vapor pressure of the test chemical was 3.86*10-21 Pa] and/or the possibility of exposure to aerosols, particles or droplets of inhalable size. Hence, this endpoint was considered for waiver.
Acute Dermal
The study was designed and conducted to determine the acute dermal toxicity profile of the given test chemical in Sprague Dawley rats. The test chemical was applied to shorn skin of 5 male and 5 female animals at 2000 mg/kg body weight.
Administration of the test item at 2000 mg/kg did not result in any skin reaction at the site of application during the study period of 14 days. Administration of the test item did not result in any signs of toxicity and mortality during the study period of 14 days. Animals exhibited normal body weight gain through the study period of 14 days. Gross pathological examination did not reveal any abnormalities attributable to the treatment.
It was concluded that the acute dermal median lethal dose (LD50) of test chemical, when administered to male and female Sprague Dawley rats was considered to be >2000 mg/kg body weight. Thus by considering the CLP criteria for acute toxicity rating for the chemicals, it can be inferred that the test chemical does not exhibit acute toxicity by the dermal route and can be considered as “Not Classified”.
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 report.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Principles of method if other than guideline:
- A study was designed and conducted to determine the acute oral toxicity profile of the test chemical in Sprague Dawley rats
- GLP compliance:
- yes
- Test type:
- acute toxic class 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: Female rats of the age of approximately 8 to 12 weeks old were used.
- Weight at study initiation : The weight were within ± 20% of the mean weight of any animal used for dosing. Body weight range was 197.4 to 205.5 grams.
Body weights at the start :
Female
Mean : 201.90 g (= 100 %)
Minimum : 197.4 g (- 2.23 %)
Maximum : 205.5 g (+ 1.78 %)
Total No. of animals : 12
- 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): Room temperature was maintained at 20.6 to 23.2 degree centigrade
- Humidity (%): Room humidity was maintained at 54.2% to 58.6%.
- Air changes (per hr): The animal room was independently provided with at least ten to fifteen air changes per hour of 100% fresh air that had been passed through the HEPA filters.
- Photoperiod (hrs dark / hrs light): An artificial light and dark cycle of 12 hours each was provided to the room.
IN-LIFE DATES: From: To: No data - Route of administration:
- oral: gavage
- Vehicle:
- other: Distilled water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: No data
- Amount of vehicle (if gavage): No data
- Justification for choice of vehicle: No data
- Lot/batch no. (if required): No data
- Purity: No data
MAXIMUM DOSE VOLUME APPLIED: The test item was administered in the dose volume of 10 ml/kg body weight.
DOSAGE PREPARATION (if unusual): No data
CLASS METHOD (if applicable) No data
- Rationale for the selection of the starting dose: No data - Doses:
- Dose Group I : 300 mg/kg
Dose Group II : 2000 mg/kg - No. of animals per sex per dose:
- Three females were used at each step.
- Control animals:
- yes
- 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.
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 at the end of the study period on day 15. 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. - Statistics:
- No data
- Preliminary study:
- No data
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: No mortality observed
- Mortality:
- Administration of the test item at 300 mg/kg did not result in any mortality after the dosing. No mortality was observed at 300 mg/kg dose group, hence additional three female animals were treated with the higher dose of 2000 mg/kg of the test item (Step - I). Administration of the test item at 2000 mg/kg did not result in any signs of toxicity and mortality after the dosing. As no mortality were observed at 24 hours after the dosing, hence additional three female animals were treated with the higher dose of 2000 mg/kg of the test item (Step - II). Administration of the test item at 2000 mg/kg did not result in any signs of toxicity and mortality after the dosing.
- Clinical signs:
- other: Group I Step I : Animals treated at the dose level of 300 mg/kg body weight did not result in any signs of toxicity during the study period of 14 days. Group I Step II : Animals treated at the dose level of 300 mg/kg body weight did not result in an
- Gross pathology:
- Gross pathological examination did not reveal any abnormalities in animals from 300 mg/kg and 2000 mg/kg dose groups.
- Other findings:
- No data
- Interpretation of results:
- other: Not Classified
- Conclusions:
- It was concluded that the acute oral median lethal dose (LD50) of the test chemical when administered to Sprague Dawley rats was considered to be greater than 2000 mg/kg body weight. Thus by considering the CLP criteria for acute toxicity rating for the chemicals, it can be inferred that the test chemical does not exhibit acute toxicity by the oral route and can be considered as “Not Classified”.
- Executive summary:
A study was designed and conducted to determine the acute oral toxicity profile of the test chemical in Sprague Dawley rats. The study was performed as per OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method) Guidelines. 12 female, nulliparous and non-pregnant Sprague Dawley rats were used for the study.
The single dose of test item was administered to fasted rats (approximately 16 hours or more) by oral intubation, using a ball-tipped intubation needle fitted onto a syringe of appropriate size. Doses were calculated using recent (after fasting) body weights. 10 ml per kg of body weight was considered the maximum volume which could be administered to a rat. Animals were given food 3-4 hours after test item administration. 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 did not result in any signs of toxicity and mortality at 24 hours after the dosing. As no mortality was observed at 24 hours after the dosing, three female animals were added to the study and treated with the same dose of 300 mg/kg of the test item (Step - II). Administration of the test item at 300 mg/kg did not result in any signs of toxicity and mortality after the dosing.
No mortality was observed at 300 mg/kg dose group, hence additional three female animals were treated with the higher dose of 2000 mg/kg of the test item (Step - I). Administration of the test item at 2000 mg/kg did not result in any signs of toxicity and mortality after the dosing. As no mortality were observed at 24 hours after the dosing, hence additional three female animals were treated with the higher dose of 2000 mg/kg of the test item (Step - II). Administration of the test item at 2000 mg/kg did not result in any signs of toxicity and mortality after the dosing.
Gross pathological examination did not reveal any abnormalities in animals from 300 mg/kg and 2000 mg/kg dose groups.
It was concluded that the acute oral median lethal dose (LD50) of the test chemical when administered to Sprague Dawley rats was considered to be greater than 2000 mg/kg body weight. Thus by considering the CLP criteria for acute toxicity rating for the chemicals, it can be inferred that the test chemical does not exhibit acute toxicity by the oral route and can be considered as “Not Classified”.
Reference
Table No. I
Summary of Clinical Signs of Toxicity and Mortality
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 |
No clinical signs observed |
3 |
1 - 3 |
0 to 14 |
0/3 |
Group I :
Step No. |
Dose mg/kg |
Observed Signs |
Total Number of Animals |
Animal Nos. |
Period of signs in days From - to |
Mortality |
II |
300 |
No clinical signs observed |
3 |
4 - 6 |
0 to 14 |
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 |
I |
2000 |
No clinical signs observed |
3 |
7 - 9 |
0 to 14 |
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 |
2000 |
No clinical signs observed |
3 |
10 - 12 |
0 to 14 |
0/3 |
Table No.II
Mean Body Weight and Percent Body Weight Gain (g)
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 |
204.07 |
215.00 |
5.35 |
229.80 |
6.89 |
12.61 |
± SD |
1.63 |
3.06 |
0.72 |
2.88 |
0.38 |
0.52 |
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 |
II |
300 |
Mean |
203.23 |
213.67 |
5.13 |
230.30 |
7.79 |
13.32 |
± SD |
1.21 |
2.60 |
0.93 |
2.25 |
0.37 |
0.93 |
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 |
2000 |
Mean |
201.13 |
214.37 |
6.58 |
231.50 |
7.99 |
15.09 |
± SD |
1.45 |
1.90 |
0.84 |
3.18 |
1.37 |
0.76 |
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 |
2000 |
Mean |
199.17 |
212.57 |
6.74 |
229.20 |
7.83 |
15.09 |
± SD |
1.55 |
2.30 |
1.87 |
2.11 |
0.18 |
1.82 |
Table No.III
Summary of Gross Pathological Findings
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 |
TS |
No abnormality detected |
Group I :
Step No. |
Dose mg/kg |
Animal Numbers |
Animal Fate |
Gross Pathological Findings |
II |
300 |
4 - 6 |
TS |
No abnormality detected |
Group II :
Step No. |
Dose mg/kg |
Animal Numbers |
Animal Fate |
Gross Pathological Findings |
I |
2000 |
7 - 9 |
TS |
No abnormality detected |
Group II :
Step No. |
Dose mg/kg |
Animal Numbers |
Animal Fate |
Gross Pathological Findings |
II |
2000 |
10 - 12 |
TS |
No abnormality detected |
TS = Terminal Sacrifice
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- Klimisch Rating 1 - experimental reports
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
- 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 report.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Principles of method if other than guideline:
- A study was designed and performed to determine the acute dermal toxicity profile of the test chemical
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/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: no
- Age at study initiation: Young adult male and female rats aged between 6 – 9 weeks were used.
- Weight at study initiation: The weight range of approximately 217.1 to 255.7 grams at initiation of dosing were used.
Body weights at the start :
Male
Mean : 246.04 g (= 100 %)
Minimum : 238.3 g (- 3.15 %)
Maximum : 255.7 g (+ 3.93 %)
Total No. of animals : 5
Female
Mean : 223.74 g (= 100 %)
Minimum : 217.1 g (- 2.97 %)
Maximum : 231.3 g (+ 3.38 %)
Total No. of animals : 5
- Fasting period before study : No data
- 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): Room temperature was maintained at 20.0 to 22.3 degree centigrade.
- Humidity (%): Room humidity was maintained at 55.7% to 59.6%.
- Air changes (per hr): The animal room was independently provided with at least ten to fifteen air changes per hour of 100% fresh air that had been passed through the HEPA filters.
- Photoperiod (hrs dark / hrs light): An artificial light and dark cycle of 12 hours each was provided to the room.
IN-LIFE DATES: No data - Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: 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.
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw
- Constant volume or concentration used: yes
- For solids, paste formed: No data
VEHICLE (not used)
- Amount(s) applied (volume or weight with unit):No data
- Concentration (if solution): No data
- Lot/batch no. (if required): No data
- Purity: No data - Duration of exposure:
- 24 hours
- Doses:
- A single dose of 2000 mg of the test item per kilogram of body weight was administered to ten rats (five males and five females).
- No. of animals per sex per dose:
- 10 (5/sex).
- Control animals:
- yes
- 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 were 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). - Statistics:
- No data
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: No mortality observed
- Mortality:
- Sex : Male
Group I - All animals survived through the study period of 14 days.
Sex : Female
Group I - All animals survived through the study period of 14 days. - Clinical signs:
- other: Sex : Male Group I - Animal treated at the dose level of 2000 mg/kg body weight did not result in any signs of toxicity during the study period of 14 days. Sex : Female Group I - Animal treated at the dose level of 2000 mg/kg body weight did not resul
- Gross pathology:
- Gross pathological examination did not reveal any abnormalities in animals from 2000 mg/kg dose group.
- Other findings:
- No data
- Interpretation of results:
- other: Not Classified
- Conclusions:
- Administration of the test item at 2000 mg/kg did not result in any skin reaction at the site of application during the study period of 14 days. Administration of the test item did not result in any signs of toxicity and mortality during the study period of 14 days. Animals exhibited normal body weight gain through the study period of 14 days. Gross pathological examination did not reveal any abnormalities attributable to the treatment.
It was concluded that the acute dermal median lethal dose (LD50) of test chemical, when administered to male and female Sprague Dawley rats was considered to be >2000 mg/kg body weight. Thus by considering the CLP criteria for acute toxicity rating for the chemicals, it can be inferred that the test chemical does not exhibit acute toxicity by the dermal route and can be considered as “Not Classified”. - Executive summary:
The study was designed and conducted to determine the acute dermal toxicity profile of the given test chemical in Sprague Dawley rats. The study was performed as per OECD 402 Guidelines. The test chemical was applied to shorn skin of 5 male and 5 female animals at 2000 mg/kg body weight.
The animals were kept in their cages for at least 5 days prior to administration for acclimatization to the laboratory condition and after acclimatization period, animals were randomly selected. Approximately 24 hours before application, the hair of each rat was closely clipped from the trunk (dorsal surface and sides from scapular to pelvic area) with an electric clipper, so as to expose at least 10% of the body surface area. The test item was applied directly onto the exposed skin of the animal, taking care to spread the test item evenly over the entire area of approximately 10% of the total body surface area or as much of the area as can reasonably be covered. The test item was held in contact with the skin using a porous gauze dressing and non irritating tape around the animal to cover the exposure site for first 24 hours exposure period. Elizabethan collar was placed on each animal for first 24 hours after application of the test item. These collars prevent ingestion of test item. Following 24 hours of exposure, the wrapping was removed and the test site wiped free of excess test item. Distilled water was used to remove residual test item.
Administration of the test item at 2000 mg/kg did not result in any skin reaction at the site of application during the study period of 14 days. Administration of the test item did not result in any signs of toxicity and mortality during the study period of 14 days. Animals exhibited normal body weight gain through the study period of 14 days. Gross pathological examination did not reveal any abnormalities attributable to the treatment.
It was concluded that the acute dermal median lethal dose (LD50) of test chemical, when administered to male and female Sprague Dawley rats was considered to be >2000 mg/kg body weight. Thus by considering the CLP criteria for acute toxicity rating for the chemicals, it can be inferred that the test chemical does not exhibit acute toxicity by the dermal route and can be considered as “Not Classified”.
Reference
Appendix No.I
Individual Animal - Clinical Signs of Toxicity and Mortality
Test System : Sprague Dawley Rat
Sex : Male
Group No. |
Dose mg/kg |
Observed Signs |
Total Number of Animals |
Animal Nos. |
Period of signs in days From - to |
Mortality |
I |
2000 |
No clinical signs observed |
5 |
1 |
0 - 14 |
0 |
2 |
0 - 14 |
0 |
||||
3 |
0 - 14 |
0 |
||||
4 |
0 - 14 |
0 |
||||
5 |
0 - 14 |
0 |
Sex : Female
Group No. |
Dose mg/kg |
Observed Signs |
Total Number of Animals |
Animal Nos. |
Period of signs in days From - to |
Mortality |
I |
2000 |
No clinical signs observed |
5 |
6 |
0 - 14 |
0 |
7 |
0 - 14 |
0 |
||||
8 |
0 - 14 |
0 |
||||
9 |
0 - 14 |
0 |
||||
10 |
0 - 14 |
0 |
Appendix No.II
Individual Animal - Evaluation of Dermal Reaction
Laboratory Test Item Code :TAS/122/008
Test System : Sprague Dawley Rat
Sex : Male
Group : I
Dose : 2000 mg/kg body weight
Animal |
Dermal |
D A Y S |
|
||||||||||||||
No. |
Reaction |
0 |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
|
1 |
Erythema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
|
Oedema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
2 |
Erythema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
|
Oedema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3 |
Erythema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
|
Oedema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
4 |
Erythema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
|
Oedema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
5 |
Erythema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
|
Oedema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Sex : Female
Group : I
Dose : 2000 mg/kg body weight
Animal |
Dermal |
D A Y S |
|
||||||||||||||
No. |
Reaction |
0 |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
|
6 |
Erythema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
|
Oedema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
7 |
Erythema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
|
Oedema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
8 |
Erythema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
|
Oedema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
9 |
Erythema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
|
Oedema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
10 |
Erythema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
|
Oedema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Appendix No.III
Individual Animal - Body Weight and Percent Body Weight Gain (g)
Test System : Sprague Dawley Rat
Sex : Male
Group : I
Dose : 2000 mg/kg body weight
Animal No. |
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 |
1 |
238.3 |
258.8 |
8.60 |
275.5 |
6.45 |
15.61 |
2 |
240.7 |
265.2 |
10.18 |
291.4 |
9.88 |
21.06 |
3 |
245.1 |
273.4 |
11.55 |
295.6 |
8.12 |
20.60 |
4 |
250.4 |
276.4 |
10.38 |
300.5 |
8.72 |
20.01 |
5 |
255.7 |
281.7 |
10.17 |
304.6 |
8.13 |
19.12 |
Sex : Female
Group : I
Dose : 2000 mg/kg body weight
Animal No. |
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 |
6 |
217.1 |
225.3 |
3.78 |
241.8 |
7.32 |
11.38 |
7 |
220.3 |
230.8 |
4.77 |
238.6 |
3.38 |
8.31 |
8 |
222.3 |
237.3 |
6.75 |
251.9 |
6.15 |
13.32 |
9 |
227.7 |
241.5 |
6.06 |
254.3 |
5.30 |
11.68 |
10 |
231.3 |
246.7 |
6.66 |
260.1 |
5.43 |
12.45 |
Appendix No.IV
Individual Animal - Gross Pathological Findings
Test System : Sprague Dawley Rat
Sex : Male
Group : I
Dose : 2000 mg/kg body weight
Animal No. |
Fate |
Gross Pathological Findings |
1 |
TS |
No abnormality detected |
2 |
TS |
No abnormality detected |
3 |
TS |
No abnormality detected |
4 |
TS |
No abnormality detected |
5 |
TS |
No abnormality detected |
Sex : Female
Group : I
Dose : 2000 mg/kg body weight
Animal No. |
Fate |
Gross Pathological Findings |
6 |
TS |
No abnormality detected |
7 |
TS |
No abnormality detected |
8 |
TS |
No abnormality detected |
9 |
TS |
No abnormality detected |
10 |
TS |
No abnormality detected |
TS = Terminal sacrifice
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- Klimisch Rating 1- experimental reports
Additional information
Acute Oral
A study was designed and conducted to determine the acute oral toxicity profile of the test chemical in Sprague Dawley rats. The study was performed as per OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method) Guidelines. 12 female, nulliparous and non-pregnant Sprague Dawley rats were used for the study.
The single dose of test item was administered to fasted rats (approximately 16 hours or more) by oral intubation, using a ball-tipped intubation needle fitted onto a syringe of appropriate size. Doses were calculated using recent (after fasting) body weights. 10 ml per kg of body weight was considered the maximum volume which could be administered to a rat. Animals were given food 3-4 hours after test item administration. 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 did not result in any signs of toxicity and mortality at 24 hours after the dosing. As no mortality was observed at 24 hours after the dosing, three female animals were added to the study and treated with the same dose of 300 mg/kg of the test item (Step - II). Administration of the test item at 300 mg/kg did not result in any signs of toxicity and mortality after the dosing.
No mortality was observed at 300 mg/kg dose group, hence additional three female animals were treated with the higher dose of 2000 mg/kg of the test item (Step - I). Administration of the test item at 2000 mg/kg did not result in any signs of toxicity and mortality after the dosing. As no mortality were observed at 24 hours after the dosing, hence additional three female animals were treated with the higher dose of 2000 mg/kg of the test item (Step - II). Administration of the test item at 2000 mg/kg did not result in any signs of toxicity and mortality after the dosing. Gross pathological examination did not reveal any abnormalities in animals from 300 mg/kg and 2000 mg/kg dose groups.
It was concluded that the acute oral median lethal dose (LD50) of the test chemical when administered to Sprague Dawley rats was considered to be greater than 2000 mg/kg body weight. Thus by considering the CLP criteria for acute toxicity rating for the chemicals, it can be inferred that the test chemical does not exhibit acute toxicity by the oral route and can be considered as “Not Classified”.
Acute Inhalation
The study need not be performed because exposure to humans via inhalation route is not likely taking into account the low vapour pressure of the test chemical [The estimated vapor pressure of the test chemical was 3.86*10-21 Pa] and/or the possibility of exposure to aerosols, particles or droplets of inhalable size. Hence, this endpoint was considered for waiver.
Acute Dermal
The study was designed and conducted to determine the acute dermal toxicity profile of the given test chemical in Sprague Dawley rats. The study was performed as per OECD 402 Guidelines. The test chemical was applied to shorn skin of 5 male and 5 female animals at 2000 mg/kg body weight.
The animals were kept in their cages for at least 5 days prior to administration for acclimatization to the laboratory condition and after acclimatization period, animals were randomly selected. Approximately 24 hours before application, the hair of each rat was closely clipped from the trunk (dorsal surface and sides from scapular to pelvic area) with an electric clipper, so as to expose at least 10% of the body surface area. The test item was applied directly onto the exposed skin of the animal, taking care to spread the test item evenly over the entire area of approximately 10% of the total body surface area or as much of the area as can reasonably be covered. The test item was held in contact with the skin using a porous gauze dressing and non irritating tape around the animal to cover the exposure site for first 24 hours exposure period. Elizabethan collar was placed on each animal for first 24 hours after application of the test item. These collars prevent ingestion of test item. Following 24 hours of exposure, the wrapping was removed and the test site wiped free of excess test item. Distilled water was used to remove residual test item.
Administration of the test item at 2000 mg/kg did not result in any skin reaction at the site of application during the study period of 14 days. Administration of the test item did not result in any signs of toxicity and mortality during the study period of 14 days. Animals exhibited normal body weight gain through the study period of 14 days. Gross pathological examination did not reveal any abnormalities attributable to the treatment.
It was concluded that the acute dermal median lethal dose (LD50) of test chemical, when administered to male and female Sprague Dawley rats was considered to be >2000 mg/kg body weight. Thus by considering the CLP criteria for acute toxicity rating for the chemicals, it can be inferred that the test chemical does not exhibit acute toxicity by the dermal route and can be considered as “Not Classified”.
Justification for classification or non-classification
Available results for the test chemical indicate that the test chemical was primarily non-toxic when exposed via oral, dermal routes of exposure. Hence, it can be classified under the category "Not Classified" as per CLP Regulation.
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