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EC number: 201-645-2 | CAS number: 85-98-3
- 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
Acute oral toxicity: EU Method B.1, GLP. Adverse effect was observed. Therefore, the acute oral toxicity of Ethyl centralite is moderate.
Acute dermal toxicity: EU Method B.3, GLP. No adverse effect was observed. Therefore, the acute dermal toxicity of Ethyl centralite is low.
Acute inhalation toxicity: Toxicology Division Procedural Guide USAEHA. No adverse effect was observed. Therefore, the acute inhalation toxicity of Ethyl centralite is low.
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:
- 18.4. - 25.4.2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: TOP VELAZ s.r.o., Praha, Czech Republic
- Weight at study initiation: 158-183 g
- Fasting period before study: 20 h
- Housing: 5 animals in one plastic breeding cage VELAZ T4
- Diet (e.g. ad libitum): standard feeding mixture ST-1 ad libitum
- Water (e.g. ad libitum): drinking tap water ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24°C
- Humidity relative (%): 30-70%
- Photoperiod (hrs dark / hrs light): 12-hour light/12 hour dark
STUDY TIME SCHEDULE
Experimental part of study: 18.4.-25.4. 2001 - Route of administration:
- oral: gavage
- Vehicle:
- olive oil
- Details on oral exposure:
- PREPARATION OF APPLICATION FORM
The single volume of administered suspension was 1mL/100 g of animal body weight.
VEHICLE
- Concentration in vehicle:
- Amount of vehicle (if gavage):
- Justification for choice of vehicle:
- Lot/batch no. (if required):
- Purity:
MAXIMUM DOSE VOLUME APPLIED:
DOSAGE PREPARATION (if unusual):
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: - Doses:
- 500, 700, 1000, 1500 mg/kg bw
- No. of animals per sex per dose:
- 5 females per dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Mortality: daily
- Body weight recording: before application, on the 8th day of the study and at the end of the study
- Clinical examination: the first day: twice (30 minutes and 3 hours after application), the second day: twice (in the morning and in the afternoon) and daily thereafter for 14 days
- Necropsy of survivors performed: yes - Statistics:
- Numeric value of toxicity was defined by Bliss method, using computer program PROBIT (VUOS 1991).
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 780.9 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 685.5 - 889.6
- Mortality:
- Dose 700 mg/kg
2 animals after 2.15 and 5.5 hrs after application
Dose 1000 mg/kg
4 animals 0.45 hrs after application
Dose 1500 mg/kg
all animals died 0.15 - 04 hrs after application - Clinical signs:
- other: Dose 500 mg/kg 30 minutes after application: Piloerection, skin anaemia, discomfort, excitation, tremor, increased reactivity 2nd day: no clinical changes Dose 700 mg/kg 30 minutes after application: Skin anaemia, discomfort, clonus, torpor, increased re
- Gross pathology:
- Dose 500 mg/kg
Without pathological changes
Dose 700 mg/kg
3 survivors - without pathological changes
2 died animal - skin anaemia, mild lung congestion, intestine anaemia, mild liver, congestion, heart-block in systole (probably consequence of abdominal muscules contraction)
Dose 1000 mg/kg
Mild lung congestion, stomach anaemia, flatulence, intestine anaemia, liver congestion
Dose 1500 mg/kg
Mild lung congestion, mild intestine anaemia, liver congestion - Interpretation of results:
- harmful
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test substance CENTRALIT is according to results of acute oral toxicity classified as harmful.
The test substance caused clinical signs of intoxication – increase neuro-muscles irritability resulted in spasm. Pathological findings were insignificant. - Executive summary:
The aim of the study was to investigate acute toxic effects of the test substance Centralit, after a single oral administration to Wistar rats (females only). Result follows in test protocol No. 0127 (March, the 3rd, 2001), when after performing of limit test, higher sensitivity for females was found out.
The testing was performed according to Regulation of Ministry of health of the Czech Republic No. 251/1998 Sb., the Method B.1: Acute Oral Toxicity (per os). This method corresponds with the guideline OECD No. 401 (1987).
According to the study results, the value of LD50 (oral) for female rats is 780.9 mg/kg of body weight.
Reference
-
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 780.9 mg/kg bw
- Quality of whole database:
- The study is a GLP compliant and has Klimish score 1.
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:
- april 1976-april 1977
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- Toxicology Division Procedural Guide, US Army Environmental Hygiene Agency (USAEHA), 1972
- GLP compliance:
- not specified
- Species:
- rat
- Sex:
- male
- Route of administration:
- inhalation
- Duration of exposure:
- 8 h
- Remarks on duration:
- single exposure
- Concentrations:
- nominal concentration - 0.4, 198 mg/L
- No. of animals per sex per dose:
- 6 males
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 14 days
- Body weight: pre-exposure day, post-exposure day 1, 3 ,7, 11
- Necropsy of survivors performed: yes
- Other examinations performed: body weight,organ-to-body weight ratios weights, histopathology - Sex:
- male
- Dose descriptor:
- LC50
- Effect level:
- > 198 mg/L air (nominal)
- Based on:
- test mat.
- Exp. duration:
- 8 h
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Acute vapor inhalation exposures of rats resulted experimentally in no deleterious effect. These results show that ethyl centralite has a low volatility and should present no hazard due to inhalation ot its vapors at room temperature. Also, if vapors are present, acute inhalation from a single exposure presemts no hazard.
Reference
TEMPERATURE 23°C
Results: Rats exposed to a nominal concentration of 0.4 mg/L for 8 hours showed no toxic signs during exposures and for 14 days thereafter. Body weight gain and organ-to-body weight ratios of the exposed rats compared to the control rats were not significantly different. No exposure related histopathologic changes were noted in tissues and organs.
Interpretation: Compound has a low volatility and should present no acute inhalation hazard from single short term exposure.
TEMPERATURE 50°C
Results: No discernible loss of test material from dispersion tube was found. Rate showed no toxic signs during exposure and 14 days thereafter. Body weight gain and the organ-to-body weight ratios of liver, kidney, lung, spleen and testes from exposed rats compared to the control rats were not significantly different. No exposure related histopathological changes were noted in tissues and organs.
Interpretation: Compound has a low volatility and should present no hazard at room temperature due to the inhalation of ethyl centralite vapors.
TEMPERATURE 100°C
Results: Compound melted and vaporized from dispersion tube into exposure chamber, all compound had been dispersed in 80 minutes at a concentration 198 mg/L. Rats showed no toxic signs during exposure and 14 days thereafter. Body weight gain and the organ-to-body weight ratios of the exposed rats compared to the control rats were not significantly different. No exposure related histopathological changes were noted in tissues and organs.
Interpretation: Vapor presents no acute inhalation hazard from single short term exposure.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LC50
- Value:
- 198 000 mg/m³ air
- Quality of whole database:
- The study is comparable to Guideline study with acceptable restrictions and has Klimish score 2.
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:
- 21.11.-7.12.2011
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- 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
- Source: Breeding farm VELAZ s.r.o., Koleč u Kladna, Czech Republic
- Weight at study initiation: average-females: 213.9 g, average-males: 252.34 g
- Housing: animal room with monitored conditions – one animal in one plastic cage
- Diet (e.g. ad libitum): ST 1 BERGMAN – standard pelleted diet
- Water (e.g. ad libitum): drinking tap water
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/-3°C
- Humidity (%): 30-70%
- Air changes (per hr): approximately 15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hour light/12 hour dark
STUDY TIME SCHEDULE
Animal supply: 16. 11. 2011
Experimental part of study: 21. 11. – 07. 12. 2011 - Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: 6x6 cm
- % coverage: aprox. 10% of the body surface
- Type of wrap if used: The application site was covered by mull and held in contact by plaster (strapping).
REMOVAL OF TEST SUBSTANCE
- Washing (if done): water
- Time after start of exposure: 24 hrs
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): according to its body weight and the dose (2000 mg/kg)
- For solids, paste formed: no - Duration of exposure:
- 24 hrs
- Doses:
- 2000 mg/kg bw.
- No. of animals per sex per dose:
- 5 females and 5 males
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
- body weight: before application, 8th day of clinical observation and at the end of study (15th day)
- mortality: daily
- clinical signs: daily
- Necropsy of survivors performed: yes - Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- The test substance did not cause death of animals.
- Clinical signs:
- other: No clinical signs of intoxication were observed.
- Gross pathology:
- No macroscopic changes were diagnosed during pathological examination in all animals.
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- According to the results of the dermal toxicity study, the value of LD50 (dermal) of test substance, Centralit, for rats is higher than 2000 mg/kg of body weight.
- Executive summary:
The test substance, Centralit, was tested for acute dermal toxicity using Wistar rats.
Testing was performed according to the Method B.3 Acute Toxicity (Dermal), Council Regulation (EC) No.440/2008, published in O.J. L 142, 2008.
The study was performed as limit test: two groups of animals – 5 males and 5 females at the dose of 2000 mg/kg of body weight. The pre-test was performed with 1 male and 1 female from each group. After end exposure test substance of these pilot animals, the other animals of the group were dosed.
The test substance was applied on the shaved skin of the test animals in delivered form for 24 hours.
The test animals were observed 14 days after exposure test substance, afterwards they were sacrificed, and the necropsy for macroscopic examination of the organs was performed.
The test substance applied at the dose of 2000 mg/kg of body weight did not cause death of animals. No clinical signs of intoxication were observed. No macroscopic change was diagnosed during pathological examination of animals.
According to the results of study, the value of LD50 (dermal) of the test substance, Centralit, for rats of both sexes is higher than 2000 mg/kg of body weight.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- The study is a GLP compliant and has Klimish score 1.
Additional information
Justification for selection of acute
toxicity – inhalation endpoint
Only one study available
Justification for selection of acute toxicity – dermal endpoint
Only one study available
Justification for classification or non-classification
Based on the available data, the substance is classified as Acute Tox.4, H302.
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