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EC number: 939-581-9 | CAS number: 1471314-81-4
- 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
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- Water solubility
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- Storage stability and reactivity towards container material
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- pH
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- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
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- Endpoint summary
- Stability
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- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data

Endpoint summary
Administrative data
Description of key information
Acute oral toxicity: weight of evidence approach including the following studies:
- Sanders (2000a): LD50 (male/female rat) between 500 and 1000 mg a.i./kg bw (OECD TG 423, K1)
- Goldschmidt GmbH (1976): LD50 (male rat) between 1500 and 2250 mg a.i./kg bw (similar OECD TG 401, K2)
- Sterner and Chibanguza (1978): LD50 (male/female rat) ca. 2184 mg a.i./kg bw (similar OECD TG 401, K2)
- Thompson (1980): LD50 (male) > 1750 mg a.i./kg bw and LD50 (female) < 1750 mg a.i./kg bw (similar OECD TG 401, K2)
Acute dermal toxicity:
Sanders (2000b): dermal LD50 > 2000 mg a.i./kg bw (OECD 402, K1)
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:
- weight of evidence
- Study period:
- no data
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- Well-documented non-GLP study performed according to a method similar to OECD TG 401.
- Qualifier:
- according to guideline
- Guideline:
- other: Appraisal of the safety of chemicals in foods, drugs and cosmetics; by the Staff of the Division of Pharmacology, FDA, 1959
- Deviations:
- not specified
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): Aminoxid WS 35
- Substance type: light-yellow, clear watery liquid
- Physical state: liquid
- Other: pH 5.0 - Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Winkelmann, Paderborn, Germany
- Age at study initiation: no data
- Weight at study initiation: 160-205 g
- Fasting period before study: 16h prior to dosage
- Housing: in groups of 5 rats in plastic cages (42x26x14 cm) on wood chips bedding.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22
- Humidity (%): 45-55
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12 - Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- Substance was administered in a 100% concentration at dosage levels of 3.98, 5.00, 6.30 and 7.94 ml/kg bw.
- Doses:
- 3.98, 5.00, 6.30 and 7.94 ml/kg.
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: animals were observed closely for gross signs of systemic toxicity and mortality at frequent intervals during the day of dosage, and at least once daily thereafter.
- Necropsy of survivors performed: yes - Statistics:
- Mortality data by Probit-analysis
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 6.24 mL/kg bw
- Based on:
- test mat.
- 95% CL:
- > 5.84 - < 6.65
- Mortality:
- After 14 days: 0/10 died at 3.98 ml/kg; 2/10 animals died at 5 ml/kg; 6/10 died at 6.30 ml/kg; 8/10 died at 7.94 ml/kg.
- Clinical signs:
- other:
- Body weight:
- other body weight observations
- Remarks:
- No effects.
- Gross pathology:
- Animals that died during the study showed slight redness of the gastro-intestinal mucous membrane and the intestine was filled with liquid.
Surviving animals did not show adverse effects. - Interpretation of results:
- GHS criteria not met
- Conclusions:
- The oral rat LD50 derived after acute exposure and a 14-day recovery period, was 6.24 ml/kg bw. Assuming a relative density of 1, the oral LD50 equals 6240 mg/kg bw. When correcting for the active content (i.e. 35%) the LD50 is 2184 mg/kg bw , which is above the classification limits of the CLP Regulation.
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- October-December 1976.
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- Non-GLP study performed similar to OECD TG 401.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- not specified
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): Varox 1770 (30% Active)
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Holtzman
- Age at study initiation: approx. 7 weeks
- Weight at study initiation: average group weights: 146, 177 and 191 g
- Fasting period before study: no data
- Housing: individually in screen bottom cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 7 days
ENVIRONMENTAL CONDITIONS
no data - Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- Substance administered as such.
- Doses:
- 5000, 7500 and 10000 mg/kg bw
- No. of animals per sex per dose:
- 6
- Control animals:
- no
- Details on study design:
- Observations were made at hourly intervals for 5h after dosing and twice daily thereafter.
Surviving animals were sacrified. Gross post mortem examinations were performed on all animals and gross tissue alterations noted. - Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 - < 7 500 mg/kg bw
- Based on:
- test mat.
- Mortality:
- 5000 mg/kg: 0/6 died
7500 mg/kg: 4/6 died on day 1 or 2
10000 mg/kg: all animals died on day 1 or 2 - Clinical signs:
- other: No data
- Body weight:
- other body weight observations
- Remarks:
- No data
- Gross pathology:
- No data
- Other findings:
- No data
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The male rat oral LD50 was estimated as being between 5000 and 7500 mg/kg bw. When correcting for the active content (i.e. 30%): the LD50 is between 1500 and 2250 mg/kg bw.
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 1999-10-20 - 1999-11-24
- 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:
- yes
- Remarks:
- Dose levels deviating from current guideline. Compliant with guideline as it was in 2000
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class 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: Charles River (UK) Ltd, Margate, Kent, UK
- Age at study initiation: eight to twelve weeks old
- Weight at study initiation: males weighed 228 to 236 g, and the females 201 to 236 g
- Fasting period before study: overnight immediately before dosing
- Housing: in groups of three by sex in solid-floor polypropylene cages furnished with wood flakes
- Diet (e.g. ad libitum): ad libitum with the exception of an overnight fast immediately before dosing and for approximately three to four hours after dosing
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25 ºC
- Humidity (%): 30 - 70 %
- Air changes (per hr): The rate of air exchange was approximately fifteen changes per hour
- Photoperiod (hrs dark / hrs light): cycles of twelve hours continuous light and twelve hours darkness. - Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 217.4 mg/ml and 21.8 mg/ml
- Amount of vehicle (if gavage): 10 ml
DOSAGE PREPARATION: The test material solutions were prepared using a correction factor based on the purity of the test substance to ensure that the animals received 2000 and 200 mg/kg of the pure test material
MAXIMUM DOSE VOLUME APPLIED: 10 mL
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: Using all available information, 2174 mg/kg bodyweight was selected as the starting dose. (This dose level was selected using a correction factor based on the purity of the supplied test material, to ensure that the animals received a dose equivalent to 2000 mg/kg bodyweight of pure test material). - Doses:
- 2174 mg/kg (equivalent to 2000 mg pure tets material/kg) and 218 mg/kg (equivalent to 200 mg pure test material/kg)
- No. of animals per sex per dose:
- 2000 mg/kg: a group of 3 female rats.
200 mg/kg: 6 rats, one group of 3 females and one group of 3 males - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Individual bodyweights were recorded prior to dosing and seven and fourteen days after treatment or at death
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs and body weight. - Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- >= 500 - <= 1 000 mg/kg bw
- Based on:
- act. ingr.
- Remarks on result:
- other: According to classification scheme in report
- Mortality:
- Two animals treated with 2174 mg/kg were found dead one or two days after dosing. There were no deaths noted at a dose level of 218 mg/kg.
- Clinical signs:
- other:
- Body weight:
- other body weight observations
- Remarks:
- All surviving animals showed expected gains in bodyweight over the study period.
- Gross pathology:
- Necropsy results of animals that died during the study (treated with 2174 mg/kg) were haemorrhagic lungs, dark liver, dark kidneys, haemorragic gastric mucosa, sloughing and/or haemorrhage of the non-glandular epithelium of the stomach and haemorrhagic small and large intestines. No abnormalities were noted at necropsy of animals that were killed at the end of the study.
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- Mortalities were noted in animals treated at 2174 mg/kg b.w. No mortalities were noted in animals treated with 218 mg/kg b.w. The acute oral LD50 of the test substance in Sprague-Dawley rats was estimated as being in the range of 500 and 1000 mg/kg of pure test substance, according to the criteria in the guideline.
- Executive summary:
The Acute Oral toxicity 'Acute Toxic Class method' study was performed in Sprague-Dawley CD strain rats. A stepwise procedure was used; a group of 3 females was treated with a dose of 2174 mg/kg (equivalent to 2000 mg of pure test material/kg) and 2 groups (3 females and 3 males) were treated with a dose of 218 mg/kg (equivalent to 200 mg of pure test material /kg). The test substance was administered as a solution in distilled water. An oral single dose of 10 ml/kg was given by gavage.
Clinical observations were made at 0.5, 1, 2, and 4 hours after dosing and subsequently once daily for up to 14 days. Individual body weights were recorded prior to dosing and 7 and 14 days after treatment or at death. All animals including those that died during the study were subjected to gross pathological observations. Two animals treated with 2174 mg/kg died. No mortalities were noted in animals treated with 218 mg/kg. The acute oral LD50 of the test substance in Sprague-Dawley rats was estimated as being in the range of 500 - 1000 mg/kg of pure test substance.
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 1980-08 - 1980-10
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- Well-documented non-GLP study performed similar to OECD TG 401
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- yes
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): VAROX 1770 (35%)
- Physical state: liquid
- Analytical purity: 35%
- Lot/batch No.: Code 659770; Lot 8066-K
- Other: bulk density 0.99 g/ml - Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan
- Age at study initiation: approx. 7 weeks
- Weight at study initiation: 222-278 g; average males: 260 g; average females: 245 g
- Fasting period before study: 17h prior to dosage (only food withheld)
- Housing: group housed
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 7 days
ENVIRONMENTAL CONDITIONS
no data - Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- Dose volume: 5.05 ml/kg bw
- Doses:
- 5000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: animals were observed for pharmacotoxic signs and mortality at 1, 2.5, and 4h after compound administration and daily thereafter. Animals were weighed just before administration and at 7 and 14 days.
- Necropsy of survivors performed: only on animals that died during the study - Statistics:
- Not applicable
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- < 5 000 mg/kg bw
- Based on:
- test mat.
- Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- Males: 2 of 5 died on day 2 and 3.
Females: all animals died on day 1 or 2. - Clinical signs:
- other:
- Body weight:
- other body weight observations
- Remarks:
- No effects
- Gross pathology:
- Males that died during study: one animal only showed severe cannibalization; the other animal showed light to dark-red mottled lungs and gastrointestinal tract with little content and distented with gas.
Females that died during study: one female showed small red areas on thymus and slightly dark lungs. The other females showed distended stomach and empty colon. One female also showed multiple dark red areas on the lung. - Interpretation of results:
- study cannot be used for classification
- Conclusions:
- The oral rat LD50 in males was found to be >5000 mg/kg bw; while the LD50 in females was <5000 mg/kg bw. When correcting for the active content (i.e. 35%) the male LD50 is >1750 mg/kg bw and the female LD50 is <1750 mg/kg bw.
Referenceopen allclose all
Other observations: none
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 1 000 mg/kg bw
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
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:
- 1999-10-20 - 1999-11-03
- 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
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
- Specific details on test material used for the study:
- - Name: NINOX HCDO
- Purity: 92%
- Physical state: off white paste
- Lot/batch No.: 876 TK
- Storage condition of test material: room temperature, in the dark - Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River (UK)
- Age at study initiation: eight to twelve weeks old
- Weight at study initiation: males 206 to 232 g, and the females 214 to 225 g.
- Housing: in suspended polypropylene cages furnished with wood flakes. The animals were housed individually during the 24-hour exposure period and in groups of five, by sex, for the remainder of the study
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25 ºC
- Humidity (%): 30-70 %
- Air changes (per hr): approximately fifteen changes per hour
- Photoperiod (hrs dark / hrs light): twelve hours continuous light and twelve hours darkness - Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: approximating to 10% of the total body surface area.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with cotton wool moistened with distilled water to remove any residual test material.
- Time after start of exposure: After the 24-hour contact period
TEST MATERIAL
- Concentration (if solution): 2174 mg/kg (equivalent to 2000 mg/kg bodyweight of pure test material). - Duration of exposure:
- 24-hours
- Doses:
- 2174 mg/kg (equivalent to 2000 mg/kg bodyweight of pure test material).
- No. of animals per sex per dose:
- Ten animals (five males and five females)
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were observed for deaths or overt signs of toxicity ½, 1, 2 and 4 hours after dosing and subsequently once daily for fourteen days. Individual bodyweights were recorded prior to application of the test material on Day 0 and on Days 7 and 14.
- Necropsy of survivors performed: yes - Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 174 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: The dose 2174 mg/kg bw is equivalent to 2000 mg/kg bw of pure test material
- Mortality:
- There were no deaths.
- Clinical signs:
- other:
- Body weight:
- other body weight observations
- Remarks:
- All animals showed expected gain in bodyweight during the study except for one female animal which showed bodyweight loss during the first week and expected gain in bodyweight during the second week.
- Gross pathology:
- No abnormalities were noted at necropsy.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute dermal median lethal dose (LD50) of the test substance in the Sprague-Dawley rat was found to be greater than 2174 mg/kg bodyweight (equivalent to 2000 mg/kg bodyweight of pure test material). The test substance is not to be classified as acute dermal toxicant according to CLP Regulation.
- Executive summary:
The Acute Dermal Toxicity assay for the test substance was performed in Sprague-Dawley rats. One female group and one male group, of 5 animals each one, were treated with a single dose of 2174 mg/kg bodyweight, equivalent to 2000 mg/kg bodyweight of pure test material (Limit test). The test material was applied uniformly to an area of shorn skin (approximating to 10% of the total body surface area). A piece of surgical gauze was placed over the treatment area and semi-occluded with a piece of self-adhesive bandage. After the 24-hour contact period the bandage was carefully removed and the treated skin and surrounding hair wiped with cotton wool moistened with distilled water. Clinical observation was conducted at 1/2,1, 2 and 4 hours after dosing and subsequently once daily for fourteen days. Body weight was controlled before the administration, on day 0 and on days 7 and 14 after the administration. All animals were subjected to gross necropsy. No test substance related effects were noted from clinical observations or post-mortem examination. The acute dermal median lethal dose (LD50) of the test substance in the Sprague-Dawley rat was found to be greater than 2174 mg/kg bodyweight (equivalent to 2000 mg/kg bodyweight of pure test material).
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
Additional information
For acute oral toxicity a weight of evidence approach is used to define an LD50 value. The Sanders (2000a) study estimated an LD50 value as being between 500 and 1000 mg/kg bw, according to OECD 423 guideline methodology in 2000. The Sterner and Chibanguza (1978) study showed an LD50 of ca. 2184 mg/kg bw, estimated using an assumed density of 1 g/ml.
The 1976 study (Goldschmidt GmbH) only used male rats and estimated an LD50 value as being between 1500 and 2250 mg/kg bw. The Thompson (1980) study showed a male LD50 of >1750 mg/kg bw and a female LD50 of <1750 mg/kg bw (corrected for the active content (i.e. 35%)).
Based on all the available data on the acute oral toxicity of this substance, an LD50 value of 1000 mg/kg bw is proposed.
Acute dermal toxicity is covered by the key study by Sanders (2000b), revealing a dermal LD50 > 2000 mg/kg bw.
Acute inhalation toxicity is waived as the other routes of exposure have been covered, and inhalation exposure is not likely during use as the substance is marketed as a dilution in water.
Justification for classification or non-classification
In view of the assumed oral LD50 value of 1000 mg a.i./kg bw, the substance should be classified for acute oral toxicity as category 4 (H302) according to the CLP Regulation.
In view of the dermal LD50 value of >2000 mg a.i./kg bw, the substance should not be classified for acute dermal toxicity according to the CLP Regulation.
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