Registration Dossier
Registration Dossier
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 942-100-5 | CAS number: -
- 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,
LC50 (inhalation) > 179 mg/kg bw,
LD50 (dermal) > 2025 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:
- key study
- Study period:
- August 27, 1986
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: 84/449/EEC; L251
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: Male (158 - 180 g)
- Diet (e.g. ad libitum): ad libitum untill 16 h before the administration - Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg bw
- Doses:
- Single dose: 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: twice a day
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, negroscopy - Statistics:
- ROSIELLO et al.: J. Tox. Environ. Health.: 3, 797 (1977)
The method is based on Maximum-Likelihood-method: BLISS: Q.J.Pharm. Protocol. : 11, 192 (1938) - Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No deaths occurred
- Clinical signs:
- other: No clinical signs observed
- Gross pathology:
- No abnormalities observed
- Interpretation of results:
- other: CLP criteria not met
- Conclusions:
- LD50 (male/female) > 5000 mg/kg bw
- Executive summary:
The substance to be registered has been tested according to EU Method B.1. During the study ten rats have been used (5 male and 5 female) for testing a single dose of 5000 mg/kg bw. No deaths occurred during the test and no abnormalities were seen in autopsy. The test item has shown a LD50 > 5000 mg/kg bw.
Reference
Table of results:
dosis (g/kg bw) | sex | dead animals | symptomatic animals | survivors |
5.0 | (male) | 0 | 0 | 5 |
5.0 | (female) | 0 | 0 | 5 |
Weight table:
female # | week | ||
0 | 1 | 2 | |
1 | 182 | 185 | 184 |
2 | 185 | 192 | 193 |
3 | 190 | 186 | 189 |
4 | 186 | 189 | 188 |
5 | 188 | 189 | 190 |
male # | week | ||
0 | 1 | 2 | |
1 | 180 | 210 | 227 |
2 | 163 | 186 | 210 |
3 | 165 | 202 | 230 |
4 | 158 | 181 | 200 |
5 | 158 | 180 | 200 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 5 000 mg/kg bw
- Quality of whole database:
- According to internationally accepted testing guidance
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- March 22, 1973
- 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 403 (Acute Inhalation Toxicity)
- Deviations:
- not applicable
- 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
- Source: ARS/Sprague - Dawley, Madison, Winsconsin
- Age at study initiation:
- Weight at study initiation: 153 g
- Fasting period before study: fasted during exposition
- Housing: individually in stock cages
- Diet (e.g. ad libitum): standard laboratory diet with Purina Rat Chow, Ralston Purina Company, St. louis, Missouri
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23°C - Route of administration:
- inhalation: dust
- Type of inhalation exposure:
- whole body
- Vehicle:
- clean air
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: Plexiglass inhalation chamber
- Exposure chamber volume: 70 liters
- Method of holding animals in test chamber:
- Source and rate of air: Dust feeder, rate of air: 6.4 L/min
- Method of particle size determination: microscopic determination
- Temperature, humidity, pressure in air chamber: 25 °C, 29.92 inches Hg
TEST ATMOSPHERE
- Samples taken from breathing zone: yes
TEST ATMOSPHERE (if not tabulated)
- Particle size distribution: 1 - 5 microns : 34%; 6 - 25 microns: 58%; 26 - 615 microns: 8% - Analytical verification of test atmosphere concentrations:
- yes
- Duration of exposure:
- ca. 4 h
- Concentrations:
- 179 mg/m3 air
- No. of animals per sex per dose:
- 5 male and 5 female
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: body weight - Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 179 mg/m³ air (analytical)
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Mortality:
- No deaths occurred
- Clinical signs:
- other: No evidence
- Body weight:
- Within the normal limits, average two-week body weight gain was 57g
- Gross pathology:
- Minimal to mild focal red discoloration of the lungs in all rats
- Other findings:
- No untoward behavioral reactions
- Conclusions:
- LC50 (male/female) > 179 mg/m3 air
- Executive summary:
The substance to be registered has been tested according a procedure similar to OECD 403. During the study the concentration of 179 mg/m3 air has been tested on ten rats (5 male and 5 female). After the 14 days observation period there were no deaths, no untoward behavioural reactions or adverse body weight effect. Necroscopy revealed minimal to mild red discoloration in the lungs of all rats. In these experimental conditions the test substance has shown a LC50 > 179 mg/m3 air.
Reference
Particle Size Distribution data:
Particle size range (microns) |
N. of Particles counted | % of total counted |
1 - 5 | 152 | 34 |
6 - 25 | 263 | 58 |
26 - 615 | 35 | 8 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LC50
- Value:
- 179 mg/m³ air
- Quality of whole database:
- Method equivalent or similar to guidelines internationally accepted.
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:
- February 26, 1973
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- not applicable
- Principles of method if other than guideline:
- Number of animals: 4 rabbits (2 male and 2 female)
- GLP compliance:
- no
- Remarks:
- Pre GLP.
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rabbit
- Strain:
- other: New Zeland
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 2.94 - 3.2 g
- Housing: individually in suspende, wire - bottomed cagesand maintained on a standard laboratory ration
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: 7 days - Type of coverage:
- occlusive
- Vehicle:
- not specified
- Details on dermal exposure:
- TEST SITE
- % coverage: 30%
- Type of wrap if used: plastic wraptaped in place
REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 24h - Duration of exposure:
- 24 h
- Doses:
- 2025 mg/kg bw
- No. of animals per sex per dose:
- 2 male and 2 female
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Initial and final body weight recorded
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, behavioral abnormalities. - Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 025 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No deaths occurred
- Clinical signs:
- other: No untoward behavioral reactions were noted
- Gross pathology:
- No gross pathologic alterations revealed
- Other findings:
- A bright blue stain noted at the 24h, 7d and 14d observations
- Interpretation of results:
- other: CLP criteria not met
- Conclusions:
- LD50 (male/female) > 2025 mg/kg bw
- Executive summary:
The substance to be registered has been tested according a procedure similar to OECD 402, during the study the single dose 2025 mg/kg bw has been tested on 4 rabbits (2 male and 2 female). After the 14 days observation period there were no deaths , untoward behavioral reactions or adverse body weight effect. A bright blue stain was noted at the contact site at 24h, 7d, 14d observations. Necroscopy revealed no gross pathologic alterations among any animals. In these experimental conditions the test item shows a LD50 > 2025 mg/kg bw.
Reference
Mortality and body weight data:
dose mg/kg bw |
animal | individual body weight | n° dead/ n°tested |
% dead | ||
n° | sex | day n° 0 | day n° 14 | |||
2025 | 1 | m | 3.2 | 3.24 | 0/4 | 0 |
2 | m | 2.94 | 2.6 | |||
3 | f | 3.2 | 3.2 | |||
4 | f | 3.2 | 3.24 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 025 mg/kg bw
- Quality of whole database:
- Method equivalent or similar to guidelines internationally accepted.
Additional information
A study on intraperitoneal acute toxicity was conducted in 1982 but only a short summary is available. During the study, the test substance showed a high value for median lethal dose (LD50 = 1790 mg/kg bw).
Justification for classification or non-classification
According to the CLP Regulation (EC) n. 1272/2008 Acute toxicity means those adverse effects occurring following oral or dermal administration of a single dose of a substance or a mixture, or multiple doses given within 24 hours, or an inhalation exposure of 4 hours.
The test subsatnce is not classified according to tables 3.1.1 and 3.1.2 of the CLP Regulation.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.

EU Privacy Disclaimer
This website uses cookies to ensure you get the best experience on our websites.