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EC number: 231-034-6 | CAS number: 7417-99-4
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
![](https://echa.europa.eu./o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Endpoint summary
Administrative data
Description of key information
Acute oral toxicity: Key study. Method according to OECD guideline 423, GLP study. The LD50 of the test item is lower than 2000 mg/kg body weight by oral route in the rat. The LD50 cut-off may be considered to be 500 mg/kg body weight by oral route in the rat.
Acute inhalation toxicity: Data waiving (study scientifically not necessary/other information available): According to REACH Annex VIII, column 2, in addition to the oral route, information from at least other route must be provided depending on the nature of the substance and the likely route of human exposure. Due to the low vapour pressure of the test material the dermal route is the second route of exposure selected.
Acute dermal toxicity: Key study. Method according to OECD guideline 402, GLP study. The LD50 of the test item is higher than 2000 mg/kg body weight by dermal route in rats.
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
- Study period:
- 01 December 2017 - 25 December 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- no
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- RccHan: WIST
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Animal Breeding Facility, Jai Research Foundation, India
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 9 to 11 weeks
- Weight at study initiation: 166.9 to 188.5 g
- Fasting period before study: overnight prior to dosing until three hours post-dosing
- Housing: 3 females in polypropylene rat cages covered with stainless steel grid top. Autoclaved clean rice husk was used as the bedding material. Wooden blocks were provided as enrichment material.
- Diet (e.g. ad libitum): Ad libitum. Teklad Certified Global High Fiber Rat/Mice Feed manufactured by Envigo, USA. The quality of feed is regularly monitored at Jai Research Foundation.
- Water (e.g. ad libitum): Ad libitum. UV sterilized water filtered through Reverse Osmosis water filtration system. The quality of water is regularly monitored at Jai Research Foundation.
- Acclimation period: 6 to 12 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 to 23°C
- Humidity (%): 49 to 66%
- Air changes (per hr): At least 15 air changes/hour
- Photoperiod (hrs dark / hrs light): 12 hours continuous light (06.00 to 18.00 h) and 12 hours darkness.
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 30 mg/mL and 200 mg/mL
- Amount of vehicle (if gavage): 10 mL
- Justification for choice of vehicle: recommended by OECD 423 guideline
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: without preliminary information, the selected starting dose is 300 mg/kg body weight. - Doses:
- 300 and 2000 mg/kg bw
- No. of animals per sex per dose:
- Set I (300 mg/kg bw): 3 animals; Set II (300 mg/kg bw): 3 animals; Set III (2000 mg/kg bw): 3 animals
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: toxicity and mortality at 30 min, 1h, 2 h, 3h, 4h, 6 h after adminitration. Morbidity and mortality twice a day and clinical sings daily during 14 days. Weighing= D0 (prior to dosing) then on D7, and D14.
- Necropsy of survivors performed: yes. At termination, macroscopic observation was observed.
- Other examinations performed:
Clinical observations: evaluation of skin and fur, eyes and mucous membranes, respiratory and circulatory effects, autonomic effects and central nervous system effects, behavioural pattern, somatomotor activity and observation of tremor, convulsions, salivation, diarrhoea, lethargy, sleep and coma. - Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 300 - <= 2 000 mg/kg bw
- Based on:
- test mat.
- Key result
- Sex:
- female
- Dose descriptor:
- LD50 cut-off
- Effect level:
- ca. 500 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality was observed in set I and set II treated at the dose level of 300 mg/kg bw.
All the rats were found dead in set III treated at the dose level of 2000 mg/kg bw. - Clinical signs:
- other: No clinical sign was observed in rats treated with 300 mg/kg bw. Clinical sign like lethargy was observed in all the rats treated with 2000 mg/kg bw.
- Gross pathology:
- External examination of found dead and terminally sacrificed rats did not reveal any abnormality.
Visceral examination of found dead rats revealed pale liver (rats treated with 2000 mg/kg bw) whereas terminally sacrificed rats did not reveal any lesion.
Lesion observed in the found dead rats could be correlated with the test item used in the present study. - Interpretation of results:
- other: Category 4 (CLP Regulation EC no. 1272/2008)
- Conclusions:
- The LD50 of the test item is lower than 2000 mg/kg body weight by oral route in the rat. The LD50 cut-off may be considered to be 500 mg/kg body weight by oral route in the rat.
- Executive summary:
The acute oral toxicity of the test item has been tested in accordance with OECD Test Guideline 423, following GLP. 9 female Wistar rats divided in 3 groups were administered sequentially with test item by oral gavage. The first set of 3 female rats was given a single dose of 300 mg/kg body weight. No mortality was observed at this dose level, so the second set of 3 female rats was treated at the same dose level. No mortality was observed at this dose level, so the third set of 3 female rats was treated at the higher dose level of 2000 mg/kg bw. All the rats were found dead at this dose level. Clinical sign like lethargy was observed from day 6 until day of death and also decrease in body weight was observed on day 7 in rats treated at this high dose. External examination of found dead and terminally sacrificed rats did not reveal any abnormality. Visceral examination of found dead rats revealed pale liver whereas terminally sacrificed rats did not reveal any lesion. Based on these results, the LD50 of the test item is lower than 2000 mg/kg body weight by oral route in the rat. The LD50 cut-off of the test item may be considered to be 500 mg/kg body weight by oral route in the rat.
Reference
Table 1: Mortality
Dose (mg/kg body weight) |
Set N° |
Number of Rats Used |
Mortality after Dosing |
||||||
At Hour |
On Day |
||||||||
0.5 – 4 |
6 |
1 |
2 |
3 |
4 - 7 |
8 - 14 |
|||
300 |
I |
3 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
II |
3 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
2000 |
III |
3 |
0 |
0 |
0 |
0 |
0 |
0 |
3 |
Table 2: Individual and Mean Body Weight (g) and Body Weight Change (%)
Dose (mg/kg body weight) |
Rat N° |
Date and Time of Dosing |
Volume of Test Item Administered (mL) |
Body Weight (g) on Day |
Percent Body Weight Change on Day |
||||
0 |
7 |
14 |
At Death |
7 |
14 |
||||
300 |
1 |
December 07, 2017 and 10:00 am |
1.67 |
166.9 |
170.4 |
207.1 |
- |
2.1 |
24.1 |
2 |
1.71 |
170.8 |
181.3 |
193.2 |
- |
6.1 |
13.1 |
||
3 |
1.73 |
173.3 |
185.6 |
200.5 |
- |
7.1 |
15.7 |
||
Mean |
170.3 |
179.1 |
200.3 |
- |
5.1 |
17.6 |
|||
Standard Deviation (±) |
3.2 |
7.8 |
7.0 |
- |
2.6 |
5.7 |
|||
4 |
December 11, 2017 and 10:30 am |
1.88 |
187.7 |
199.3 |
209.4 |
- |
6.2 |
11.6 |
|
5 |
1.89 |
188.5 |
191.9 |
196.3 |
- |
1.8 |
4.1 |
||
6 |
1.86 |
186.4 |
195.9 |
204.5 |
- |
5.1 |
9.7 |
||
Mean |
187.5 |
195.7 |
203.4 |
- |
4.4 |
8.5 |
|||
Standard Deviation (±) |
1.1 |
3.7 |
6.6 |
- |
2.3 |
3.9 |
|||
2000 |
7 |
December 13, 2017 and 10:30 am |
1.82 |
181.7 |
154.9 |
- |
134.1 |
-14.7 |
- |
8 |
1.85 |
185.1 |
155.7 |
- |
132.3 |
-15.9 |
- |
||
9 |
1.80 |
180.2 |
151.5 |
- |
130.6 |
-15.9 |
- |
||
Mean |
182.3 |
154.0 |
- |
- |
-15.5 |
- |
|||
Standard Deviation (±) |
2.5 |
2.2 |
- |
- |
0.7 |
- |
Key: Day 0 = Before dosing , - = Not applicable
Table 3: Individual clinical observations
Set I
Dose (mg/kg body weight) |
Rat N° |
Clinical Signs Observed Post-dosing |
|||||
At Hour (Day 0) |
|||||||
0.5 |
1 |
2 |
3 |
4 |
6 |
||
300 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
2 |
1 |
1 |
1 |
1 |
1 |
1 |
|
3 |
1 |
1 |
1 |
1 |
1 |
1 |
Dose (mg/kg body weight) |
Rat N° |
Clinical Signs Observed Post-dosing |
|||||||||||||
On Days |
|||||||||||||||
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
||
300 |
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 |
|
3 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
Set II
Dose (mg/kg body weight) |
Rat N° |
Clinical Signs Observed Post-dosing |
|||||
At Hour (Day 0) |
|||||||
0.5 |
1 |
2 |
3 |
4 |
6 |
||
300 |
4 |
1 |
1 |
1 |
1 |
1 |
1 |
5 |
1 |
1 |
1 |
1 |
1 |
1 |
|
6 |
1 |
1 |
1 |
1 |
1 |
1 |
Dose (mg/kg body weight) |
Rat N° |
Clinical Signs Observed Post-dosing |
|||||||||||||
On Days |
|||||||||||||||
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
||
300 |
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 |
Set III
Dose (mg/kg body weight) |
Rat N° |
Clinical Signs Observed Post-dosing |
|||||
At Hour (Day 0) |
|||||||
0.5 |
1 |
2 |
3 |
4 |
6 |
||
2000 |
7 |
1 |
1 |
1 |
1 |
1 |
1 |
8 |
1 |
1 |
1 |
1 |
1 |
1 |
|
9 |
1 |
1 |
1 |
1 |
1 |
1 |
Dose (mg/kg body weight) |
Rat N° |
Clinical Signs Observed Post-dosing |
|||||||||||||
On Days |
|||||||||||||||
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
||
2000 |
7 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
11 |
11 |
11, 2 |
- |
- |
- |
- |
8 |
1 |
1 |
1 |
1 |
1 |
11 |
11 |
11 |
11 |
2 |
- |
- |
- |
- |
|
9 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
11 |
11 |
11, 2 |
- |
- |
- |
- |
Clinical Signs: 1 = Normal, 2 = Dead, 11 = Lethargy
Note: Day 0 = Day of dosing, - = Not Applicable
Table 4: Individual necropsy findings
Dose (mg/kg body weight) |
Set N° |
Rat N° |
Mode of Death |
External |
Internal |
300 |
I |
1 |
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 |
||
II |
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 |
||
2000 |
III |
7 |
Found dead |
No abnormality detected |
Liver:Pale (1+) |
8 |
Found dead |
No abnormality detected |
Liver:Pale (2+) |
||
9 |
Found dead |
No abnormality detected |
Liver:Pale (+) |
Key: + = Minimal, 1+ = Mild, 2+ = Moderate
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 500 mg/kg bw
- Quality of whole database:
- Key study with Klimisch score = 1
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
- Justification for type of information:
- JUSTIFICATION FOR DATA WAIVING
According to REACH Annex VIII, column 2, in addition to the oral route information from at least other route must be provided depending on the nature of the substance and the likely route of human exposure. Due to the low vapour pressure of the test material the dermal route is the second route of exposure selected.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 01 December 2017 - 01 January 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- no
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- RccHan: WIST
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Animal Breeding Facility, Jai Research Foundation, India
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 9 to 11 weeks
- Weight at study initiation: 219.8 to 226.0 g
- Fasting period before study: No
- Housing: 3 females in polypropylene rat cages covered with stainless steel grid top. Autoclaved clean rice husk was used as the bedding material. Wooden blocks were provided as enrichment material.
- Diet (e.g. ad libitum): Ad libitum. Teklad Certified Global High Fiber Rat/Mice Feed manufactured by Envigo, USA. The quality of feed is regularly monitored at Jai Research Foundation.
- Water (e.g. ad libitum): Ad libitum. UV sterilized water filtered through Reverse Osmosis water filtration system. The quality of water is regularly monitored at Jai Research Foundation.
- Acclimation period: 6 to 12 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 to 23°C
- Humidity (%): 49 to 66%
- Air changes (per hr): At least 15 air changes/hour
- Photoperiod (hrs dark / hrs light): 12 hours continuous light (06.00 to 18.00 h) and 12 hours darkness.
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure:
- % coverage: at least 10%
- Type of wrap if used: porous gauze dressing (not more than 8 ply) and a non-irritating tape (Medi tape 330 hypo-allergenic surgical tape)
REMOVAL OF TEST SUBSTANCE
- Washing (if done): cotton soaked in RO water (freshly collected)
- Time after start of exposure: 24h
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 200, 1000 and 2000 mg/kg body weight
- Concentration (if solution): N/A
- Constant volume or concentration used: N/A
- For solids, paste formed: no - Duration of exposure:
- 24 h
- Doses:
- Range finding study: 200, 1000 and 2000 mg/kg body weight
Main study: 2000 mg/kg body weight - No. of animals per sex per dose:
- Range finding study: 1 female per dose
Main study: 2 females per dose - Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: toxicity and mortality at 0.5, 2, 4 and 6 h post-dermal application on the day of dosing (day 0). Morbidity and mortality twice a day. Erythema and oedema were recorded at 24 h, 48 h and 72 h post patch removal. The clinical signs were recorded once a day. Individual body weight was recorded prior to dermal application on day 0 and on days 7 and 14 post dermal application.
- Necropsy of survivors performed: yes
- Other examinations performed:
Clinical observations: evaluation of skin and fur, eyes and mucous membranes, respiratory and circulatory effects, autonomic effects and central nervous system effects, behavioural pattern, somatomotor activity and observation of tremor, convulsions, salivation, diarrhoea, lethargy, sleep and coma. - Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred during the study.
- Clinical signs:
- other: No clinical signs related to the administration of the test item were observed. Erythema and oedema was not evident at 24, 48 and 72 h post patch removal in all the rats.
- Gross pathology:
- The macroscopic examinations of the animals at the end of the study did not reveal treatment-related changes.
- Interpretation of results:
- other: No category (CLP Regulation EC no. 1272/2008)
- Remarks:
- EU criteria.
- Conclusions:
- The LD50 of the test item is higher than 2000 mg/kg body weight by dermal route in rats.
- Executive summary:
The acute dermal toxicity of the test item was studied according to OECD 402 (GLP study). 5 female Wistar rats were tested for a exposure period of 24 h. Initially, a range finding study was conducted sequentially at doses of 200, 1000 and 2000 mg/kg bw in one animal per dose. Based on the results of range finding two additional rats were tested sequentially at a dose of 2000 mg/kg bw. At the end of the 24 h exposure period, the residual test item was removed with cotton soaked in RO water.The skin reactions of each rats were observed at 24, 48 and 72 h post patch removal.The rats were observed for a period of 14 days. There were no treatment-related mortality, clinical signs or necropsy findings recorded. Body weight gain was normal for all rats except for one rat whose body weight decreased on days 7 and 14 compared to day 0 but increased from day 7 to 14. Erythema and oedema was not evident at 24, 48 and 72 h post patch removal in all the rats. Based on the results of the study, the test item was found to be non toxic, with an LD50 > 2000 mg/kg bw.
Reference
Table 1: Individual and Mean Body Weight (g) and Body Weight Change (%)
Dose (mg/kg body weight) |
Date and Time of Dosing |
Animal N° |
Volume of test itemApplied (mL) |
Body Weights (g) on Day |
Percent Body Weight Change on Day |
|||
0 |
7 |
14 |
7 |
14 |
||||
200 |
December 07, 2017 and 10:15 am |
1 |
43.96 |
219.8 |
235.0 |
250.3 |
6.9 |
13.9 |
1000 |
December 11, 2017 and 10:20 am |
2 |
226.0 |
226.0 |
232.9 |
236.3 |
3.1 |
4.6 |
2000 |
December 13, 2017 and 10:35 am |
3 |
451.8 |
225.9 |
226.9 |
232.0 |
0.4 |
2.7 |
December 15, 2017 and 10:40 am |
4 |
447.4 |
223.7 |
231.7 |
240.1 |
3.6 |
7.3 |
|
December 18, 2017 and 10:45 am |
5 |
441.0 |
220.5 |
210.0 |
212.1 |
-4.8 |
-3.8 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- Key study with Klimisch score = 1
Additional information
Acute oral toxicity: Key study. The acute oral toxicity of the test item has been tested in accordance with OECD Test Guideline 423, following GLP. 9 female Wistar rats divided in 3 groups were administered sequentially with test item by oral gavage.The first set of 3 female rats was given a single dose of 300 mg/kg body weight. No mortality was observed at this dose level, so the second set of 3 female rats was treated at the same dose level. No mortality was observed at this dose level, so the third set of 3 female rats was treated at the higher dose level of 2000 mg/kg bw. All the rats were found dead at this dose level. Clinical sign like lethargy was observed from day 6 until day of death and also decrease in body weight was observed on day 7 in rats treated at this high dose. External examination of found dead and terminally sacrificed rats did not reveal any abnormality. Visceral examination of found dead rats revealed pale liver whereas terminally sacrificed rats did not reveal any lesion. Based on these results, the LD50 of the test item is lower than 2000 mg/kg body weight by oral route in the rat. The LD50 cut-off of the test item may be considered to be 500 mg/kg body weight by oral route in the rat.
Acute inhalation toxicity: Data waiving (study scientifically not necessary/other information available): According to REACH Annex VIII, column 2, in addition to the oral route, information from at least other route must be provided depending on the nature of the substance and the likely route of human exposure. Due to the low vapour pressure of the test material the dermal route is the second route of exposure selected.
Acute dermal toxicity: Key study. The acute dermal toxicity of the test item was studied according to OECD 402 (GLP study). 5 female Wistar rats were tested for a exposure period of 24 h. Initially, a range finding study was conducted sequentially at doses of 200, 1000 and 2000 mg/kg bw in one animal per dose. Based on the results of range finding two additional rats were tested sequentially at a dose of 2000 mg/kg bw. At the end of the 24 h exposure period, the residual test item was removed with cotton soaked in RO water.The skin reactions of each rats were observed at 24, 48 and 72 h post patch removal.The rats were observed for a period of 14 days. There were no treatment-related mortality, clinical signs or necropsy findings recorded. Body weight gain was normal for all rats except for one rat whose body weight decreased on days 7 and 14 compared to day 0 but increased from day 7 to 14. Erythema and oedema was not evident at 24, 48 and 72 h post patch removal in all the rats. Based on the results of the study, the test item was found to be non toxic, with an LD50 > 2000 mg/kg bw.
Justification for classification or non-classification
Based on the available data, the substance is classified as category 4 for acute toxicity (oral) according to CLP Regulation (EC) no. 1272/2008.
Based on the available data, the substance is not classified for acute toxicity (dermal) according to CLP Regulation (EC) no. 1272/2008.
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