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EC number: 222-492-8 | CAS number: 3495-36-1
- 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
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:
- From February 21, 2007 to March 29, 2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- no
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River (UK) Ltd, Margate, Kent, UK
- Age at study initiation: Eight to twelve weeks of age
- Weight at study initiation: Since the animals are 8-12 weeks old, hence weight should be approximately 200-250 g
- Housing: Propylene cages furnished with woodflakes
- Diet (e.g. ad libitum): Certified rat and mouse diet
- Water (e.g. ad libitum): Drinking water
- Acclimation period: 5 d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25 ˚C
- Humidity (%): 30-70 %
- Air changes (per hr): 15 changes per h
- Photoperiod (hrs dark / hrs light): 12 h continuous light (06:00 to 18:00) and 12 h darkness - Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: For 300 mg/kg – 30 mg/mL; For 2000 mg/kg – 2127.7 mg/mL (calculated from the dose volume 0.94 ml/kg)
- Amount of vehicle (if gavage): No data
- Justification for choice of vehicle: Test substance is highly soluble in water. Moreover distilled water is an inert vehicle and will not interfere with the subsequent evaluation of results
- Lot/batch no. (if required): No data
- Purity: No data
MAXIMUM DOSE VOLUME APPLIED: For 300 mg/kg - 10 ml/kg; For 2000 mg/kg – 0.94 ml/kg
DOSAGE PREPARATION (if unusual): The specific gravity was determined and used to calculate the appropriate dose volume for the required dose level. The test substance was freshly prepared as a solution in distilled water.
For 300 mg/kg, the test substance was dissolved in the distilled water at a concentration of 30 mg/ml.
For 2000 mg/kg, the test substance was dissolved in distilled water to achieve a dose volume of 0.94 ml/kg.
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: Using available information on toxicity of test material, 300 mg/kg was chosen as the starting dose. - Doses:
- 300 and 2000 mg/kg
- No. of animals per sex per dose:
- Sighting test: 1 animal per dose group of 300 and 2000 mg/kg
Main test: 4 animals per dose group of 300 and 2000 mg/kg - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 d
- Frequency of observations and weighing: Daily for observations and weekly for weighing
- Necropsy of survivors performed: Yes
- Other examinations performed:
Clinical signs: Clinical observations were performed ½, 1, 2 and 4 h after dosing and then daily for up to 14 d.
Body weight: Body weights were recorded on Day 0 (the day of dosing) and on Days 7 and 14 or at death.
Organ weights: Not applicable
Histopathology: Not applicable
Other: Mortality and morbidity checks were performed twice daily. - Preliminary study:
- No toxicity was observed in the two animals treated with 300 and 2000 mg/kg
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 300 - < 2 000 mg/kg bw
- Mortality:
- Dose level: 2000 mg/kg
4/5 were found dead during the day of dosing or one day after dosing
Dose level: 300 mg/kg
There was no mortality - Clinical signs:
- Dose level: 2000 mg/kg
Treatment related clinical signs were observed in 1/5 animals at 4 h after dosing followed which the animal was found dead. The clinical signs included reduced activity, hunched posture, ataxia and piloerection.
Dose level: 300 mg/kg
No signs of systemic toxicity were observed during the observation period. - Body weight:
- Dose level: 2000 mg/kg
The only surviving animal gained body weight normally throughout the observation period.
Dose level: 300 mg/kg
All animals showed expected gains in body weight over the observation period. - Gross pathology:
- Dose level: 2000 mg/kg
The necropsy of animals (4/5 rats) that died during the observation period showed abnormally red lungs, dark liver and kidneys and haemorrhage in gastric mucosa. No abnormalities were observation at necropsy of the surviving animal.
Dose level: 300 mg/kg
No gross pathological abnormalities were observed at necropsy in any animal. - Conclusions:
- Under the study conditions, the LD50 of the test substance in Sprague Dawley rats was greater than 300 mg/kg bw but lower than 2000 mg/kg bw.
- Executive summary:
A study was conducted to determine the acute oral toxicity of the test substance to Sprague-Dawley CD (crl: CD®(SD) IGS BR) rats according to OECD Guideline 420, in compliance with GLP. A sighting test was performed with a single female rat at 300 mg/kg bw. In the absence of toxicity at this dose level, another female rat was treated with 2000 mg/kg bw. In the absence of toxicity at 2000 mg/kg, an additional group of 4 female rats were treated with the same dose level, i.e. 2000 mg/kg bw. Due to the absence of mortality and signs of systemic toxicity at 2000 mg/kg bw, an additional 4 animals were treated at 300 mg/kg bw. At the end of the observation period, the surviving animals were killed by cervical dislocation and subjected to gross necropsy. All four animals at 2000 mg/kg bw were found dead on the day of dosing or one day after dosing. There were no mortalities or clinical signs observed at 300 mg/kg bw. The surviving animal at 2000 mg/kg bw showed clinical signs such as hunched posture, lethargy, ataxia and piloerection. All surviving animals showed expected gain in bodyweight over the observation period. No abnormalities were recorded at necropsy of the animals that were killed at the end of the study. Under the study conditions, the LD50 of the test substance in Sprague Dawley rats was greater than 300 mg/kg bw but lower than 2000 mg/kg bw (Sanders, 2007).
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From January 7, 1997 to January 30, 1997
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 798.1175 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- no
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMAL
-Source: Harlan Sprague Dawley, Inc. P. O. Box 29176, Indianapolis, IN 46229
- Age at study initiation: Adult
- Weight at study initiation: Males – 251-302 g, Females – 205-233 g (Day 0 body weights)
- Fasting period before study: None
- Housing: Wire mesh suspension cages
- Diet (e.g. ad libitum): Teklad 4 % Mouse/Rat Diet
- Water (e.g. ad libitum): Tap water
- Acclimation period: At least 5 d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 64-79 ˚F
- Humidity (%): 30-70 %
- Air changes (per hr): 15 changes per h
- Photoperiod (hrs dark / hrs light): 12 h light/dark cycle
IN-LIFE DATES: From: January 7, 1997 To: January 30, 1997 - Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: The test substance was administered undiluted using the bulk density to determine the dose volume. Individual doses were calculated using post-fasting body weights.
DOSAGE PREPARATION (if unusual): Test substance was used undiluted
CLASS METHOD (if applicable): Not applicable
- Rationale for the selection of the starting dose: Not reported - Doses:
- 1250, 1580, 2000 and 5000 mg/kg
- No. of animals per sex per dose:
- Five
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 d
- Frequency of observations and weighing: All surviving animals were observed frequently for gross signs of systemic toxicity and mortality on the day of test material administration and at least twice daily.
- Necropsy of survivors performed: Yes
- Other examinations performed:
Clinical signs: Clinical signs were observed frequently on the day of dosing and at least twice daily from Day 2 until Day 14.
Body weight: Body weights were measured for each animal on the day of dosing, on Day 7 of the observation period, and at the ti me of necropsy (scheduled or in the event of death)
Organ weights: Not applicable
Histopathology: Not applicable
Other: Gross pathological observations were recorded for all necropsied animals. - Statistics:
- Not reported
- Preliminary study:
- Not performed
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- ca. 1 780 other: mg/kg bw
- 95% CL:
- ca. 200 - ca. 15 610
- Mortality:
- Males: 4/5 animals in 5000 mg/kg and 5/5 animals at 2000 mg/kg dose level died on Day 1. The surviving animal at 5000 mg/kg died by Day 1. There was no mortality at 1580 and 1250 mg/kg doses.
Females: 4/5 animals at 5000 mg/kg and 2/5 animals at 2000 mg/kg died on Day 0 of dosing. All the surviving animals at 5000 mg/kg and 4/5 animals at 2000 mg/kg died by Day 1. There were no mortalities in the lower doses. - Clinical signs:
- Varying degrees of clinical signs like reduced activity, convulsions, respiratory distress, jaw movements, ataxia and external staining was observed across all dose levels from 1580 mg/kg. The only effect observed at 1250 mg/kg was fecal stains.
- Body weight:
- All surviving animals exhibited body weight gain at Day 14.
- Gross pathology:
- Presence of clear yellow fluid in the stomach and intestines, hemorrhagic lungs, congested kidneys and darkened spleen were observed in animals died at 2000 and 5000 mg/kg doses. Additionally, liver mottling were observed in 2/5 females at 5000 mg/kg dose. No gross pathological changes were observed at necropsy of the lower dose level animals.
External urine/fecal staining was observed in animals that died on Days 0 and 1. - Interpretation of results:
- other: Acute oral LD50 = 1780 mg/kg
- Conclusions:
- Under the study conditions, the acute oral LD50 value was calculated to be 1780 mg/kg bw with 95 % confidence intervals of 200 and 15610 mg/kg bw.
- Executive summary:
A study was conducted to determine the LD50 of the test substance in rats according to OECD Guideline 401 (acute oral toxicity test), in compliance with GLP. Male and female Sprague Dawley rats were exposed to a single dose of undiluted test substance at 0, 1250, 1580, 2000 and 5000 mg/kg bw and observed for 14 days. Clinical signs of reduced activity, convulsions, respiratory distress, ataxia and jaw movements were observed in animals of both sexes at 2000 and 5000 mg/kg bw. 100% mortality occurred in males at 2000 and 5000 mg/kg bw by Day 1. All animals at 5000 mg/kg and 4/5 animals at 2000 mg/kg bw in females died by Day 1. No mortality was observed at the lower doses in either sex. Gross pathological observations at necropsy/death revealed signs of stomach/small intestinal irritation. Under the study conditions, the acute oral LD50 value was calculated to be 1780 mg/kg bw with 95 % confidence intervals of 200 and 15610 mg/kg bw (Harrod, 1997).
Referenceopen allclose all
Using the mortality data obtained an estimate of the acute oral median lethal dose (LD50) of the test material was made.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 1 780 mg/kg bw
Acute toxicity: via inhalation route
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:
- From August 5, 2009 to September 3, 2009
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- yes
- Remarks:
- humidity was outside the protocol range but did not affect study outcome
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- other: Limit test
- Limit test:
- yes
- Species:
- other: albino rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Texas Animal Specialities, Humble, TX
- Weight at study initiation: Males: 232-269 g,
Females: 178-197 g
- Housing: Cage was suspended,wire bottom,stainless steel
- Diet (e.g. ad libitum): PMI feeds Inc. Formulab#5008,Ad libitum
- Water (e.g. ad libitum): Municipal water supply analysed by TCEQ water utilities division;tap water,ad libitum
- Acclimation period: 7 d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-22 ⁰C
- Humidity (%): 54-92% (humidity was outside the protocol range but did not affect study outcome.
- Air changes (per hr): 10-12 air changes/h
- Photoperiod (hrs dark / hrs light): 12 h light/dark cycle - Type of coverage:
- not specified
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: Dorsal surface of the trunk
- % coverage: 10%
- Type of wrap if used: Non-irritationg adhesive tape
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes
- Time after start of exposure: 24 h
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg (2528 mg/kg of the solution)
- Constant volume or concentration used: Yes - Duration of exposure:
- 24 h
- Doses:
- Single dose of 2000 mg/kg bw of test substance (2528 mg/kg bw of solution as received, consisting of 79.1 % test substance)
- No. of animals per sex per dose:
- 5 males/dose
5 females/dose - Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Three times on the day of dosing (day 0) and once daily for 14 days.
- Necropsy of survivors performed: Yes
- Other examinations performed: Clinical signs, body weight,organ weights, histopathology, other: Body weight were recorded just prior to dosing and on Day 7 and 14, Dermal irritation was measured at approx. 60 mins after removal of wrapping and on Day 4, 7, 11,14 - Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- act. ingr.
- Mortality:
- No mortality
- Clinical signs:
- The only clinical sign was red crusts around the eye of one animal on Days 7-14 (female).
- Body weight:
- No effect on the bodyweight gain, except one animal that lost weight during second week.
- Gross pathology:
- No observable abnormalities in gross necropsy, except an empty stomach in one animal.
- Conclusions:
- Under the study conditions the estimated LD50 of test substance was found to be greater than 2000 mg/kg bw.
- Executive summary:
A study was conducted to determine the dermal toxicity and relative skin irritancy of the test substance according to OECD Guideline 402, in compliance with GLP.A single dose of 2000 mg/kg bw of test substance (2528 mg/kg bw of solution as received, consisting of 79.1% test substance) was applied to the intact skin of albino rats. No mortality occurred during the study. The only clinical sign was red crust around the eye of one animal on Days 7 - 14. There were no signs of dermal irritation and no effect on body weight gain (except one animal that lost weight during second week). No observable abnormalities in gross necropsy (except an empty stomach in one animal) were noted.Under the study conditions, the LD50 of the test substance was found to be greater than 2000 mg/kg bw (Kuhn, 2009).
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
Additional information
Oral
A study was conducted to determine the LD50 of the test substance in rats according to OECD Guideline 401 (acute oral toxicity test), in compliance with GLP. Male and female Sprague Dawley rats were exposed to a single dose of undiluted test substance at 0, 1250, 1580, 2000 and 5000 mg/kg bw and observed for 14 days. Clinical signs of reduced activity, convulsions, respiratory distress, ataxia and jaw movements were observed in animals of both sexes at 2000 and 5000 mg/kg bw. 100% mortality occurred in males at 2000 and 5000 mg/kg bw by Day 1. All animals at 5000 mg/kg and 4/5 animals at 2000 mg/kg bw in females died by Day 1. No mortality was observed at the lower doses in either sex. Gross pathological observations at necropsy/death revealed signs of stomach/small intestinal irritation. Under the study conditions, the acute oral LD50 value was calculated to be 1780 mg/kg bw with 95 % confidence intervals of 200 and 15610 mg/kg bw (Harrod, 1997).
A study was conducted to determine the acute oral toxicity of the test substance to Sprague-Dawley CD (crl: CD®(SD) IGS BR) rats according to OECD Guideline 420, in compliance with GLP. A sighting test was performed with a single female rat at 300 mg/kg bw. In the absence of toxicity at this dose level, another female rat was treated with 2000 mg/kg bw. In the absence of toxicity at 2000 mg/kg, an additional group of 4 female rats were treated with the same dose level, i.e. 2000 mg/kg bw. Due to the absence of mortality and signs of systemic toxicity at 2000 mg/kg bw, an additional 4 animals were treated at 300 mg/kg bw. At the end of the observation period, the surviving animals were killed by cervical dislocation and subjected to gross necropsy. All four animals at 2000 mg/kg bw were found dead on the day of dosing or one day after dosing. There were no mortalities or clinical signs observed at 300 mg/kg bw. The surviving animal at 2000 mg/kg bw showed clinical signs such as hunched posture, lethargy, ataxia and piloerection. All surviving animals showed expected gain in bodyweight over the observation period. No abnormalities were recorded at necropsy of the animals that were killed at the end of the study. Under the study conditions, the LD50 of the test substance in Sprague Dawley rats was greater than 300 mg/kg bw but lower than 2000 mg/kg bw (Sanders, 2007).
Dermal
A study was conducted to determine the dermal toxicity and relative skin irritancy of the test substance according to OECD Guideline 402, in compliance with GLP. A single dose of 2000 mg/kg bw of test substance (2528 mg/kg bw of solution as received, consisting of 79.1% test substance) was applied to the intact skin of albino rats. No mortality occurred during the study. The only clinical sign was red crust around the eye of one animal on Days 7 - 14. There were no signs of dermal irritation and no effect on body weight gain (except one animal that lost weight during second week). No observable abnormalities in gross necropsy (except an empty stomach in one animal) were noted. Under the study conditions, the LD50 of the test substance was found to be greater than 2000 mg/kg bw (Kuhn, 2009).
Justification for classification or non-classification
The available acute toxicity data (oral LD50 of 1780 mg/kg bw and dermal LD50 > 2000 mg/kg bw) suggests that the substance should be classified as Acute Tox. 4 - H302: Harmful if swallowed according to CLP (EC 1272/2008) criteria.
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