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EC number: 267-032-7 | CAS number: 67762-73-6
- 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
The acute oral median lethal dose (LD50) of the registered substance in male Sprague-Dawley rats was estimated to be greater than 10,000 mg/kg bw. The registered substance did not meet the criteria for classification according to Regulation (EC) No.1272/2008 on the Classification, Labelling and Packaging of Substances and Mixtures.
The acute dermal median lethal dose (LD50) of the registered substance in New Zealand white rabbits was estimated to be greater than 3160 mg/kg bw. The registered substance did not meet the criteria for classification according to Regulation (EC) No.1272/2008 on the Classification, Labelling and Packaging of Substances and Mixtures.
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:
- 1970
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- yes
- Remarks:
- substance was tested above the limit dose; males used instead of females; missing data on animals
- Principles of method if other than guideline:
- Study was conducted using a method equivalent to OECD Testing Guideline 423 and meets acceptable scientific standards. Groups of five animals received doses up to 10,000 mg/kg bw of the registered substance in ethanol and were observed for 14 days. Mortality and clinical signs were recorded, and a gross necropsy was performed. As a result, it is considered that the study is providing a sufficient amount of data to conclude regarding the acute toxicity of the registered substance.
- GLP compliance:
- no
- Test type:
- acute toxic class method
- Limit test:
- no
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River
- Weight at study initiation: 209 - 245 g
- Fasting period before study: overnight - Route of administration:
- oral: gavage
- Vehicle:
- ethanol
- Details on oral exposure:
- 20 % ethanol used as a solvent
- Doses:
- Five dosages ranging from 34.6 g to 10,000 mg/kg bw
- No. of animals per sex per dose:
- Five male rats per dose
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observed at one, four and 24 hours and then daily thereafter
- Necropsy of survivors performed: yes - Statistics:
- None
- Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 10 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: no deaths observed
- Mortality:
- None
- Clinical signs:
- other: None
- Gross pathology:
- No gross alterations observed
- Other findings:
- None
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute oral median lethal dose (LD50) of the test substance in male Sprague-Dawley rats was estimated to be greater than 10,000 mg/kg body weight. The registered substance did not meet the criteria for classification according to Regulation (EC) No.1272/2008 on the Classification, Labelling and Packaging of Substances and Mixtures.
- Executive summary:
Male sprague-dawley rats were orally exposed by oral intubation to different doses of the test substance by a method similar to OECD guideline 423. Five dosage levels were used ranging from 34.6 g to 10,000 mg/kg of body weight. After the 14 days observation period no clinical observations were noted and there were no deaths at any of the concentrations. No gross alterations were noted during necropsy of the animals. It was therefore estimated that the LD50 was greater than 10,000 mg/kg bw. The test substance did not meet the criteria for classification according to Regulation (EC) No.1272/2008 on the Classification, Labelling and Packaging of Substances and Mixtures.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 10 000 mg/kg bw
- Quality of whole database:
- The study was considered as reliable with restriction as it was conducted on the registered substance (as defined in section 1.1) and meets acceptable scientific standards, but before the implementation of GLP and of the OECD Testing Guideline.
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:
- 1970
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- yes
- Remarks:
- substance was tested above the limit dose; missing data on animals
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- No data present beyond the species, strain and that both sexes were used
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: clipped abraded abdominal skin
- Type of wrap if used: binders of rubber dam, gauze and adhesive tape
REMOVAL OF TEST SUBSTANCE
- Washing (if done): cleansed with corn oil
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 50, 200, 794, 3160 mg/kg bw - Duration of exposure:
- 24 hours
- Doses:
- 50, 200, 794, 3160 mg/kg bw
- No. of animals per sex per dose:
- 4 animals per dosage level. No data showing the number of sexes in each group
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: animals observed at 1, 4 and 24 hours and then daily. Observations were for mortality and toxic effects.
- Necropsy of survivors performed: yes - Statistics:
- None
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 3 160 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: No deaths observed at any dosage level
- Mortality:
- None
- Clinical signs:
- other: All animals showed slight or moderate erythema that never lasted beyond day 9. Desquamation noted at the 2 highest concentrations and edema and atonia observed in the highest. Severity and duration showed a dose response effect (see results table)
- Gross pathology:
- None observed
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The LD50 for the test substance dermal exposure to rabbits is assumed to be >3160 mg/kg bw as no mortality was observed ar any of the tested concentrations. The test substance did not meet the criteria for classification according to Regulation (EC) No.1272/2008 on the Classification, Labelling and Packaging of Substances and Mixtures.
- Executive summary:
Following a protocol equivalent to OECD guideline 402, New Zealand white rabbits were exposed dermally to the test substance. Four rabbits were tested at each of the four concentrations. Some slight to moderate clinical effects were observed following a dose dependent pattern, but had all disappeared before the end of the observation period. No mortality was observed at any of the concentrations indicating the LD50 for dermal exposure to the registered substance is greater than 3160 mg/kg bw. No gross alterations were observed after necropsy of the animals. The registered substance did not meet the criteria for classification according to Regulation (EC) No.1272/2008 on the Classification, Labelling and Packaging of Substances and Mixtures.
Reference
Signs of dermal irritation observed in male and female albino rabbits.
Observation interval (days) | 50 mg/kg | 200 mg/kg | 794 mg/kg | 3,160 mg/kg | ||||
Erythema | Erythema | Erythema | Desquamation | Erythema | Edema | Atonia | Desquamation | |
1 | +(4) | +(4) | +(3) ++(1) | - | +(2)++(2) | +(2) | - | - |
2 | - | +(1) | +(4) | - | +(2)++(2) | +(2) | - | - |
3 | - | - | +(4) | - | +(4) | - | +(1) | - |
4 | - | - | - | +(4) | +(3) | - | - | +(2) |
5 | - | - | - | +(3) | +(2) | - | - | +(2) |
6 | - | - | - | +(3) | +(1) | - | - | +(2) |
7 | - | - | - | +(3) | - | - | - | +(3) |
8 | - | - | - | +(1) | - | - | - | +(3) |
9 | - | - | - | - | - | - | - | +(1) |
+ = slight
++ = moderate
+++ = severe
(x) = number of animals showing that effect
- = no toxicity observed
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 3 160 mg/kg bw
- Quality of whole database:
- The study was considered as reliable with restriction as it was conducted on the registered substance (as defined in section 1.1) and meets acceptable scientific standards, but before the implementation of GLP and of the OECD Testing Guideline.
Additional information
The acute toxicity: oral of the registered substance was determined according to a method similar to OECD Guideline for Testing of Chemicals 423 with deviations. Male sprague-dawley rats were treated with doses ranging from 34.6 mg/kg bw to 10,000 mg/kg bw. All animals were subjected to gross necropsy. At dose 10,000 mg/kg bw there was no mortality, no abnormalities were noted at necropsy. The acute oral median lethal dose (LD50) of the test substance in the male Sprague-Dawley rats was estimated to be greater than 10,000 mg/kg bw.
The acute toxicity: dermal of the registered substance was determined
according to a method similar to OECD Guideline for Testing of Chemicals
402 with deviations. Male and female New Zealand white rabbits were
treated with doses ranging from 50 mg/kg bw to 3,160 mg/kg bw. All
animals were subjected to gross necropsy. Some slight to moderate
clinical effects were observed following a dose dependent pattern. At
dose 3,160 mg/kg bw there was no mortality, no abnormalities were noted
at necropsy. The acute dermal median lethal dose (LD50) of the
registered substance in the male and female New Zealand white rabbits
was estimated to be greater than 3,160 mg/kg bw.
Justification for selection of acute toxicity – oral endpoint
Study was conducted using a method equivalent to OECD Testing
Guideline 423 and meets acceptable scientific standards. The study was
conducted on the registered substance.
Justification for selection of acute toxicity – dermal endpoint
Study was conducted using a method equivalent to OECD Testing
Guideline 402 and meets acceptable scientific standards. The study was
conducted on the registered substance.
Justification for classification or non-classification
The acute oral median lethal dose (LD50) of the test substance in male Sprague-Dawley rats was estimated to be greater than 10,000 mg/kg body weight. The test substance did not meet the criteria for classification according to Regulation (EC) No.1272/2008 on the Classification, Labelling and Packaging of Substances and Mixtures.
The acute dermal median lethal dose (LD50) of the test substance in New Zealand white rabbits was estimated to be greater than 3160 mg/kg body weight. The test substance did not meet the criteria for classification according to Regulation (EC) No.1272/2008 on the Classification, Labelling and Packaging of Substances and Mixtures.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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