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EC number: 248-595-8 | CAS number: 27668-52-6
- Life Cycle description
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- Endpoint summary
- Appearance / physical state / colour
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- Additional physico-chemical information
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- Endpoint summary
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- 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
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- Toxicological Summary
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- Genetic toxicity
- Carcinogenicity
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- 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 experimental study conducted on rats 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 5.8 x10-14 mm Hg = 0.0000000000077 Pascal.
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 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 experimental study report.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Principles of method if other than guideline:
- The purpose of this study was to assess the Toxicological profile of test item to a single administration via oral route to Sprague Dawley rats.
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- no
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: National Institute of Biosciences, Pune
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 8 to 12 weeks
- Weight at study initiation: 196.2 to 206.4 grams
Female: Mean : 200.63 g (= 100 %)
Minimum : 196.2 g (- 2.21 %)
Maximum : 206.4 g (+ 2.87 %)
Total No. of animals : 12
- Fasting period before study: 16 hrs prior
- Housing:polycarbonate cages
- Diet (e.g. ad libitum): Rodent feed supplied by the Nutrivet Life Sciences, Pune
- Water (e.g. ad libitum):Water was provided ad libitum from individual bottles attached to the cages. All water was from a local source and passed through the reverse osmosis membrane before use.
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.1 to 22.2 degree centigrade
- Humidity (%): 56.1% to 61.1%.
- Air changes (per hr): ten to fifteen air changes per hour of 100% fresh air
- Photoperiod (hrs dark / hrs light): An artificial light and dark cycle of 12 hours each
IN-LIFE DATES: From: To:19-05-2017 to 29-07-2017 - Route of administration:
- oral: gavage
- Vehicle:
- other: Distilled water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle:
- Amount of vehicle (if gavage):
- Justification for choice of vehicle:
- Lot/batch no. (if required):
- Purity:
MAXIMUM DOSE VOLUME APPLIED:
DOSAGE PREPARATION (if unusual):
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: - Doses:
- Dose Group I : 300 mg/kg
Dose Group I : 300 mg/kg
Dose Group II : 2000 mg/kg
Dose Group II : 2000 mg/kg - No. of animals per sex per dose:
- Three females were used at each step.
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Twice daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other:Animals were observed for clinical signs, mortality and morbidity, until sacrifice.
Onset, duration and severity of any sign were recorded. The clinical signs and mortality observations were conducted at immediately (0 to 5 minutes), 5, 10, 30,60 minutes, 2, 4 and 6 hours on the day of dosing and once daily thereafter for 14 day. Daily observation was done as far as possible at the same time.
The observations were included general clinical signs, observations of eyes, mucous membranes, respiratory, circulatory system and behavior pattern.
Body weights:
Individual animal body weights were recorded, before fasting, prior to administration of the test item (fasting body weights), weekly thereafter and at termination on day 14. Weight changes were calculated and recorded.
Gross Pathology:
Necropsy was performed on all animals 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.
Histopathology:
No gross abnormalities were observed in animals sacrificed terminally hence, no histopathology was performed. - Statistics:
- not specified
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- Group I
Step I :
Animals treated at the dose level of 300 mg/kg body weight: All animals survived through the study period of 14 days.
Group I
Step II :
Animals treated at the dose level of 300 mg/kg body weight: All animals survived through the study period of 14 days.
Group II
Step I :
Animals treated at the dose level of 2000 mg/kg body weight: All animals survived through the study period of 14 days.
Group II
Step II :
Animals treated at the dose level of 2000 mg/kg body weight: All animals survived through the study period of 14 days. - Clinical signs:
- other: Group I Step I : Animals treated at the dose level of 300 mg/kg body weight 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 test chemical, when administered to female Sprague Dawley rats was considered greater than 2000 mg/kg body weight.Thus, according to CLP criteria for acute toxicity rating for the chemicals, it infers that test chemical does not classify as an acute oral toxicant.
CLP Classification:Not classified - Executive summary:
The reported study was designed and conducted to determine the acute oral toxicity profile of test chemical in Sprague Dawley rats.
Initially, three female animals were treated at the dose level of 300 mg/kg body weight of the test item (Step - I). Administration of the test item at 300 mg/kg 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, 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.
Thus, it was concluded that the acute toxicity study of test chemical, when administered via oral route in Sprague Dawley rats falls into the “Category: Not classified” criteria of CLP.
Reference
Table No. I
Summary of Clinical Signs of Toxicity and Mortality
Laboratory Test Item Code :TAS/122/032
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 |
1,2,3 |
Day 0 - Day 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 |
4,5,6 |
Day 0 - Day 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 |
7,8,9 |
Day 0 - Day 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 |
10,11, 12 |
Day 0 - Day 14 |
0/3 |
Table No.II
Mean Body Weight and Percent Body Weight Gain (g)
Laboratory Test Item Code :TAS/122/032
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 |
196.77 |
213.63 |
8.57 |
230.50 |
7.90 |
17.14 |
± SD |
0.55 |
3.25 |
1.45 |
3.77 |
0.83 |
1.61 |
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 |
202.90 |
220.93 |
8.87 |
241.57 |
9.33 |
19.04 |
± SD |
3.08 |
6.22 |
1.54 |
7.51 |
0.33 |
2.04 |
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 |
203.47 |
216.43 |
6.36 |
232.50 |
7.42 |
14.26 |
± SD |
2.15 |
5.41 |
1.61 |
5.67 |
0.35 |
1.60 |
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 |
199.40 |
215.27 |
7.94 |
231.50 |
7.52 |
16.07 |
± SD |
2.17 |
6.67 |
2.18 |
8.97 |
0.88 |
3.25 |
Table No.III
Summary of Gross Pathological Findings
Laboratory Test Item Code :TAS/122/032
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:
- Data is Klimisch 1 and from experimental 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:
- This study was designed to determine the dermal LD50 of the test item (up to 2000 mg/kg) or to establish a non-lethal dose level of 2000 milligram of test item per kilogram of body weight.
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: National Institute of Biosciences, Pune
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 8 – 12 weeks
- Weight at study initiation:
Male Female
Mean : 244.22 g (= 100 %)
Minimum : 241.1 g (- 1.28 %)
Maximum : 246.8 g (+ 1.06 %)
Total No. of animals : 5
Mean : 220.38 g (= 100 %)
Minimum : 217.6 g (- 1.26 %)
Maximum : 222.4 g (+ 0.92 %)
Total No. of animals : 5
- Fasting period before study: 16 hrs
- Housing: polycarbonate cages with paddy husk as bedding
- Diet (e.g. ad libitum): Rodent feed supplied by the Nutrivet Life Sciences, Pune, was provided ad libitum from individual feeders.
- Water (e.g. ad libitum):Water was provided ad libitum from individual bottles attached to the cages. All water was from a local source and passed through the reverse osmosis membrane before use.
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.7 to 21.8 degree centigrade
- Humidity (%): 56.2% to 60.1%.
- Air changes (per hr): 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): light and dark cycle of 12 hours
IN-LIFE DATES: From: To:19-05-2017 to 28-07-2017 - Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: trunk (dorsal surface and sides from scapular to pelvic area)
- % coverage: 10% of the body surface area
- Type of wrap if used: porous gauze dressing and non irritating tape used.
Elizabethan collar was placed on each animal for first 24 hours after application of the test item. These collars prevent ingestion of test item.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): wrapping was removed and the test site wiped free of excess test item. Distilled water was used to remove residual test item.
- Time after start of exposure: 24 hrs
TEST MATERIAL
- Amount(s) applied (volume or weight with unit):2000 mg of the test item per kilogram of body weight
- Constant volume or concentration used: yes
- Duration of exposure:
- 24 hrs
- 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:
- Ten rats (5 male and 5 female)
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: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.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other:
Animals were observed for clinical signs, mortality, until sacrifice.
Onset, duration and severity of any sign were recordedThe 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).
Histopathology:
No gross abnormalities were observed in animals sacrificed terminally hence, no histopathology was performed. - Statistics:
- No data
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- 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 result
- Gross pathology:
- Gross pathological examination did not reveal any abnormalities in animals from 2000 mg/kg dose group.
- Other findings:
- Sex : Male
Group I -
Animal treated at the dose level of 2000 mg/kg body weight did not result in any skin reaction 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 result in any skin reaction during the study period of 14 days. - Interpretation of results:
- other: Not classified
- Conclusions:
- 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 greater than 2000 mg/kg body weight.Thus, according to CLP criteria for acute toxicity rating for the chemicals, it infers that test chemical does not classify as an acute dermal toxicant.
CLP Classification:Not classified - Executive summary:
The reported study was designed and conducted to determine the acute dermal toxicity profile of test chemical in Sprague Dawley rats.
The test item 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 greater than 2000 mg/kg body weight. Thus, according to CLP criteria for acute toxicity rating for the chemicals, it infers that test chemical does not classify as an acute dermal toxicant.
CLP Classification: Not classified
Reference
Table No. I
Summary of Clinical Signs of Toxicity and Mortality
Laboratory Test Item Code :TAS/122/032
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 - 5 |
Day 0 - Day 14 |
0/5 |
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 - 10 |
Day 0 - Day 14 |
0/5 |
Table No. II
Summary of Evaluation of Dermal Reaction
Laboratory Test Item Code :TAS/122/032
Test System : Sprague Dawley Rat
Sex : Male
Group No. |
Dose mg/kg |
Dermal Reaction |
Total Number of Animals |
Animal Nos. |
Period of signs in days From - to |
Mortality |
I |
2000 |
No dermal reaction observed |
5 |
1 - 5 |
Day 0 - Day 14 |
0/5 |
Sex : Female
Group No. |
Dose mg/kg |
Dermal Reaction |
Total Number of Animals |
Animal Nos. |
Period of signs in days From - to |
Mortality |
I |
2000 |
No dermal reaction observed |
5 |
6 - 10 |
Day 0 - Day 14 |
0/5 |
Table No.III
Mean Body Weight and Percent Body Weight Gain (g)
Laboratory Test Item Code :TAS/122/032
Test System : Sprague Dawley Rat
Sex : Male
Group No. |
Dose (mg/kg body weight) |
|
Body weight Day 0 |
Body weight Day 7 |
% body weight gain day 0-7 |
Body weight Day 14 |
% body weight gain day 7- 14 |
% body weight gain day 0- 14 |
I |
2000 |
Mean |
244.22 |
270.30 |
10.68 |
295.46 |
9.31 |
20.98 |
± SD |
2.11 |
3.66 |
0.93 |
5.23 |
1.17 |
2.02 |
Sex : Female
Group No. |
Dose (mg/kg body weight) |
|
Body weight Day 0 |
Body weight Day 7 |
% body weight gain day 0-7 |
Body weight Day 14 |
% body weight gain day 7- 14 |
% body weight gain day 0- 14 |
I |
2000 |
Mean |
220.38 |
236.16 |
7.15 |
247.40 |
4.76 |
12.26 |
± SD |
1.92 |
4.77 |
1.38 |
5.11 |
1.22 |
1.79 |
Table No.IV
Summary of Gross Pathological Findings
Laboratory Test Item Code :TAS/122/032
Test System : Sprague Dawley Rat
Sex : Male
Group No. |
Dose mg/kg |
Animal Numbers |
Animal Fate |
Gross Pathological Findings |
I |
2000 |
1 - 5 |
TS |
No abnormality detected |
Sex : Female
Group No. |
Dose mg/kg |
Animal Numbers |
Animal Fate |
Gross Pathological Findings |
I |
2000 |
6 - 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:
- Data is Klimisch 1 and from experimental study report.
Additional information
Acute oral toxicity:
The reported study was designed and conducted to determine the acute oral toxicity profile of test chemical in Sprague Dawley rats.
Initially, three female animals were treated at the dose level of 300 mg/kg body weight of the test item (Step - I). Administration of the test item at 300 mg/kg 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, 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.
Thus, it was concluded that the acute toxicity study of test chemical, when administered via oral route in Sprague Dawley rats falls into the “Category: Not classified” criteria of CLP.
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 be5.8 x10-14 mm Hg = 0.0000000000077 Pascal.
Thus, exposure to inhalable dust, mist and vapour of the chemical is highly unlikely. Therefore this study is considered for waiver.
Acute dermal toxicity:
The reported study was designed and conducted to determine the acute dermal toxicity profile of test chemical in Sprague Dawley rats.
The test item 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 greater than 2000 mg/kg body weight. Thus, according to CLP criteria for acute toxicity rating for the chemicals, it infers that test chemical does not classify as an acute dermal toxicant.
CLP Classification: Not classified
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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