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EC number: 228-819-0 | CAS number: 6359-98-4
- 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
Endpoint summary
Administrative data
Description of key information
LD50 (oral) > 5000 mg/kg bw
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
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- documentation insufficient for assessment
- Principles of method if other than guideline:
- Groups of four Sprague-Dawley rats (two males and two females) were intubated with the sample at selected close levels, i.e. 4600, 6800, 10200, 15400 mg/kg. All doses were administered by gavage. Following oral administration of the test material, the rats were observed for the succeeding 14 days. Initial and final body weights as well as all mortalities and/or reactions displayed were recorded. A necropsy was conducted on any animal which died during the study as well as on all animals sacrificed at the end of the 14 days.
- GLP compliance:
- no
- Remarks:
- pre GLP
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: from 150 to 227 grams.
- Housing: following oral administration of the test material, the rats were housed individually in suspended, wire-mesh cages.
- Fasting period before study: 16 hours period immediately prior to oral intubation.
- Diet: standard laboratory diet, ad libitum.
- Water: ad libitum.
- Acclimation period: all animals were kept under observation for five days prior to experimental use, during which period they were checked for general physical health and suitability as test animals. - Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- All doses were administered directly into the stomachs of the rats using a hypodermic syringe equipped with a ball-tipped intubating needle.
The test material was administered as a 50. 0 percent (w/v) aqueous suspension. - Doses:
- 4600, 6800, 10200, 15400 mg/kg
- No. of animals per sex per dose:
- 2 males and 2 females
- Details on study design:
- - Duration of observation period following administration: 14 days.
- Observations and weighing: initial and final body weights as well as all mortalities and/or reactions displayed were recorded.
- Necropsy of survivors performed: necropsy was conducted on any animal which died during the study as well as on all animals sacrificed at the end of the 14 days. - Statistics:
- At the end of the observation period, the acute oral median lethal dose (LD50) of each test material was calculated using the techniques of Weil, Thompson, and Thompson and Weil.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 10 200 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: Standard Deviation of LD50 = ± 1200 mg/kg
- Mortality:
- No death occurred at 4600 and 6800 mg/kg. At 10200 2 oput of 4 rats died, while at 15400 mg/kg no rat survived.
- Clinical signs:
- other: Hypoactivity and ruffed fur were observed at 4600 mg/kg; hypoactivity, ruffed fur and muscular weakness at the two middle doses. At the highest tested dose hypoactivity, ruffed fur, muscular weakness and prostration were observed.
- Gross pathology:
- Necropsy of the animals that died revealed gastroenteritis. No gross pathologic alterations were noted among the animals sacrificed at the end of the 14-day observation period.
- Interpretation of results:
- other: not classified, according to the CLP Regulation (EC 1272/2008)
- Conclusions:
- LD50: 10200 mg/Kg bw.
- Executive summary:
Method
Young albino rats of the Sprague-Dawley strain were used in order to assess the cute toxicity potential by otral route of the test item. Selected groups of four rats (two males and two females) were intubated with the sample at selected close levels, i.e. 4600, 6800, 10200, 15400 mg/kg. All doses were administered directly into the stomachs of the rats using a hypodermic syringe equipped with a ball-tipped intubating needle. Following oral administration of the test material, the rats were observed for the succeeding 14 days. Initial and final body weights as well as all mortalities and/or reactions displayed were recorded. A necropsy was conducted on any animal which died during the study as well as on all animals sacrificed at the end of the 14 days.
Results
No death occurred at 4600 and 6800 mg/kg; at 10200 mg/kg 2 out of 4 rats died, while at 15400 mg/kg no rat survived.
Hypoactivity and ruffed fur were observed at 4600 mg/kg; hypoactivity, ruffed fur and muscular weakness at the two middle doses. At the highest tested dose hypoactivity, ruffed fur, muscular weakness and prostration were observed.
Necropsy of the animals that died revealed gastroenteritis. No gross pathologic alterations were noted among the animals sacrificed at the end of the 14-day observation period.
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- documentation insufficient for assessment
- Principles of method if other than guideline:
- Healthy Sprague-Dawley were administered with a 25 % w/v solution of the compound in tap water, as a single dose by gavage at a rate of 20 ml/kg (equivalent to 5000 mg/kg of compound). 5 males and 5 females were used. Symptoms and mortality after administration were recorded during an observation period of 14 days. At the end of the observation period surviving animals were killed by exsanguination under ether anaesthesia and an autopsy performed.
- GLP compliance:
- no
- Remarks:
- pre GLP
- 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
- Breeding: testing laboratory.
- Age at study initiation: 7 weeks.
- Weight at study initiation: average body weight of 163 g for females and 206 g for males.
- Housing: rats were caged singly.
- Fasting period before study: 18 hours
- Diet: commercial palletad diet (Dakes Special Diet with added Vit. E), ad libitum.
- Water: ad libitum.
ENVIRONMENTAL CONDITIONS
- Temperature: 21 ± 2 °C
- Photoperiod: 12 hours artificial light and 12 hours darkness, in each 24 hour period. - Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 25 % w/v solution of the compound in tap water.
- Rate: 20 ml/kg. - Doses:
- 5000 mg/kg bw
- No. of animals per sex per dose:
- 5 males and 5 females
- Details on study design:
- - Duration of observation period following administration: 14 days.
- Observations and weighing: deaths and clinical symptoms were recorded.
- Necropsy of survivors performed: at the end of the observation period surviving animals were killed by exsanguination under ether anaesthesia and an autopsy performed. - Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No deaths occurred during the 14 day observation period.
- Clinical signs:
- other: Faeces were stained orange 24 hours after administration of the compound.
- Gross pathology:
- At autopsy no changes in organs or tissues caused by the administration of the test compound were seen.
- Interpretation of results:
- other: not classified, according to the CLP Regulation (EC 1272/2008)
- Conclusions:
- LD50 > 5000 mg/Kg bw
- Executive summary:
Method
Healthy Sprague-Dawley were administered with a 25 % w/v solution of the compound in tap water, as a single dose by gavage at a rate of 20 ml/kg (equivalent to 5000 mg/kg of compound). 5 males and 5 females were used. Symptoms and mortality after administration were recorded during an observation period of 14 days. At the end of the observation period surviving animals were killed by exsanguination under ether anaesthesia and an autopsy performed.
Results
Faeces were stained orange 24 hours after administration of the compound. No deaths occurred during the 14 day observation period. At autopsy no changes in organs or tissues caused by the administration of the test compound were seen.
- Endpoint:
- acute toxicity: oral
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- documentation insufficient for assessment
- Justification for type of information:
- Justification for Read Across is detailed in the report attached to the IUCLID section 13.
- Reason / purpose for cross-reference:
- read-across source
- Principles of method if other than guideline:
- Substance was administered, as water solution, by gavage to 10 rats. A single dose of 5000 mg/kg was given. Animals were observed for the successive 14 days.
- GLP compliance:
- no
- Remarks:
- pre GLP
- Species:
- rat
- Strain:
- Wistar
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 150 - 200 g - Route of administration:
- oral: gavage
- Vehicle:
- water
- Doses:
- 5000 mg/kg
- No. of animals per sex per dose:
- 10 animals
- Details on study design:
- Duration of observation period following administration: 14
- Statistics:
- Probit-Analysis (Fink and Hund, Arzneimitteiforsch. 15, 1 965, 62).
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No death occurred.
- Clinical signs:
- other: Poisoning symptom: none
- Interpretation of results:
- other: not classified, according to the CLP Regulation
- Conclusions:
- LD50 > 5000 mg/Kg bw
- Executive summary:
Method
Substance was administered, as water solution, by gavage to 10 rats. A single dose of 5000 mg/kg was given. Animals were observed for the successive 14 days. Unfortunately, only a summary sheet is available, thus details on testing procedures and results are lacking.
Results
No death occurred and no poisoning symptoms were recorded.
Referenceopen allclose all
Mortality and Body Weight Data
Dose (mg/kg) | Animal N. and sex | Individual body weight (g) | Number Dead/Number Tested | Percent Dead |
|
Test day N. | |||||
0 | 14 | ||||
4600 | 1M | 184 | 242 | 0/4 | 0 |
2M | 160 | 244 | |||
3F | 174 | 194 | |||
4F | 172 | 177 | |||
6800 | 5M | 182 | 250 | 0/4 | 0 |
6M | 177 | 250 | |||
7F | 158 | 192 | |||
8F | 158 | 167 | |||
10200 | 9M | 178 | (6-22 hrs) | 2/4 | 50 |
10M | 205 | 268 | |||
11F | 156 | (6-22 hrs) | |||
12F | 150 | 178 | |||
15400 | 13M | 160 | (6-22 hrs) | 4/4 |
100 |
14M |
189 |
(6-22 hrs) |
|||
15F |
163 |
(6-22 hrs) |
|||
16F |
184 |
(6-22 hrs) |
Summary of Reactions
Dose (mg/kg) | Reaction | Time of onset after dose administration | Duration of reaction |
4600 | Hypoactivity | 1 hour | 2 days |
Ruffed fur | 6 - 2 2 hours | 1 day | |
6800 | Hypoactivity | 1 hour | 3 days |
Ruffed fur | 5 hours | 3 days | |
Muscular weakness | 5 hours | 1 day | |
10200 | Hypoactivity | 1 hour | 3 days |
Ruffed fur | 1 hour | 3 days | |
Muscular weakness | 3 hours | 2 days | |
15400 | Hypoactivity | 1 hour | Until death |
Ruffed fur | 1 hour | Until death | |
Muscular weakness | 1 hour | Until death | |
Prostration | 5 hours | Until death |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 5 000 mg/kg bw
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
According to the CLP Regulation (EC 1272/2008), substances can be allocated to one of four toxicity categories based on acute toxicity by the oral, dermal or inhalation route according to the numeric criteria. Acute toxicity values are expressed as (approximate) LD50 (oral, dermal) or LC50 (inhalation) values or as acute toxicity estimates (ATE).
In the case of oral exposure route, the acute toxicity hazard categories and acute toxicity estimates (ATE) defining the respective categories are:
- category 1: ATE ≤ 5 mg/kg bw
- category 2: 5 < ATE ≤ 50 mg/kg bw
- category 3: 50 < ATE ≤ 300 mg/kg bw
- category 4: 300 < ATE ≤ 2000 mg/kg bw
The acute oral LD50 in rats was established to be greater than 5000 mg/kg bw.
Therefore, the substance is not classified for acute toxicity according to the CLP Regulation (EC n. 1272/2008).
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