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EC number: 252-346-9 | CAS number: 35074-77-2
- 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
In four acute oral toxicity studies LD50 values of greater than 5000 mg/kg bw were determined for several species (hamster, mouse and rat). No mortality was observed in any of the tested species. In an acute inhalation study a LC50 of greater than 1700 mg/m3 air (aerosol, maximum attainable concentration) was determined in rats. A dermal LD50 of greater than 10000 mg/kg bw was determined and no mortality was observed in an acute dermal toxicity study with rabbits.
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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Non GLP and non guideline study. Meets generally accepted scientific standards. No details are given regarding the test substance like purity etc. Information regarding clinical signs or gross necropsy are not presented.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- Only four animals of each sex were used for each dosing group. No details are given regarding clinical signs or gross necropsy.
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: approx. 12 weeks
- Fasting period before study: yes, overnight
- Diet: ad libitum
- Water: ad libitum - Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 50% - Doses:
- 1250, 2500, 5000 mg/kg bw (screening test)
5000 mg/kg bw (main study) - No. of animals per sex per dose:
- 1 (screening test)
4 (main study) - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Necropsy of survivors performed: no - Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No deaths were observed up to the highest tested dose.
- Clinical signs:
- other: No data
- Gross pathology:
- No data
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 5 000 mg/kg bw
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Non GLP study. Scientifically acceptable study report equivalent to OECD guideline 403. Specific data regarding the test substance are missing.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Deviations:
- yes
- Remarks:
- Animals were only observed for 8 days.
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- other: RAI
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: in house breed
- Age at study initiation: 7 - 8 weeks old
- Weight at study initiation: 180 - 185 g
- Housing: groups of 9 animals in macrolon cages (Type 4)
- Diet: ad libitum,
- Water: ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±1
- Humidity (%): ca. 50 - Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- nose only
- Vehicle:
- air
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: according to Niessen et al. (Arch. Toxicol. 20, 44-60 (1963))
- Method of holding animals in test chamber: separate PVC tubes
- Rate of air: 10 L/min
- System of generating particulates/aerosols: a pressure nozzle was used.
- Method of particle size determination: The particle-size distribution in the aerosol was determined gravimetrically on Selectron-Filters, pore size 0.2 µm (Schleicher and Schuell, 8714 Feldbach, Switzerland) every hour with the aid of a "Cascade Impactor" (CT. Casella and Co. Ltd., London N.l, England)
TEST ATMOSPHERE
- Samples taken from breathing zone: yes
VEHICLE
- Composition of vehicle: Ethanol
- Concentration of test material in vehicle: 20%
TEST ATMOSPHERE
- Particle size distribution: 2% >7 µm; 39% 3-7 µm; 51% 1-3 µm; 14% <1 µm - Analytical verification of test atmosphere concentrations:
- yes
- Duration of exposure:
- 4 h
- Concentrations:
- 1688±195 mg/m3
- No. of animals per sex per dose:
- 9
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 8 days
- Frequency of observations: daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs - Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 1.7 mg/L air
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Mortality:
- No mortality was observed.
- Clinical signs:
- other: After the 4-hour exposure the rats showed lateral position and apathy. Rats that were only treated with the vehicle did not show any toxic symptoms.
- Body weight:
- Not determined.
- Gross pathology:
- No gross internal lesions were observed.
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information
- Conclusions:
- The LC50 of the test item determined after an observation period of 7 days in rats of both sexes, exposed to the substance for four hours is greater than 1700 mg/m^3, air.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating conc.
- Value:
- 1 700 mg/m³ air
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:
- Dec. 1969 - Jan. 1970
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Non GLP study. Scientifically acceptable report with few methodological defiencies. Only two dose levels with 4 animals each were tested.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- yes
- Remarks:
- Only two dose levels were tested. Only 4 animals were used at each dose level. Half of the animals were abraded.
- 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:
- TEST ANIMALS
- Source: in house breed
- Weight at study initiation: 2 - 3 kg
- Housing: individually
- Diet: ad libitum, Altromin K (ALTROMIN GmbH, Lage/Lippe))
- Water: ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21±2
- Humidity (%): 60±3
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- semiocclusive
- Vehicle:
- not specified
- Details on dermal exposure:
- TEST SITE
- Area of exposure: back was shaved and half of the animals were abraded.
- Type of wrap if used: rubber sleeve
TEST MATERIAL
- Concentration: 50% suspension - Duration of exposure:
- Refer to observation period. Skin sites were not washed after 24 hours with the semiocclusive dressing.
- Doses:
- 2500, 10000 mg/kg bw
- No. of animals per sex per dose:
- 4
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily observations and weekly weighings
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight - Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 10 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality was observed.
- Clinical signs:
- other: No clinical signs were observed.
- Gross pathology:
- No gross internal lesions were observed during necropsy.
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 10 000 mg/kg bw
Additional information
Acute oral toxicity
In the first acute oral toxicity study, groups of male and female Wistar rats (4/sex) were given a single oral dose of the test substance in corn oil per gavage at a dose level of 5000 mg/kg bw (Shell, 1978). Animals were then observed for 14 days. No mortality was observed in any of the dosing groups. A LD50 of greater than 5000 mg/kg bw was determined.
In the second acute oral toxicity study similar to OECD guideline 401, groups of male and female Tif:MAGf mice (5/sex) were given a single oral dose of the test substance in polyethylene glycol per gavage at dose levels of 4640, 6000 and 7750 mg/kg bw (Ciba-Geigy, 1978). Animals were then observed for 14 days. Within 2 hours after treatment the rats in all dosage groups showed sedation, dyspnoea, curved position and ruffled fur. Additionally in the highest dosage group ventral position was also observed. All animals recovered within 8 to 14 days. No mortality was observed and no gross internal lesions were observed during necropsy in any of the animals. A LD50 of greater than 7750 mg/kg bw was determined.
In the third acute oral toxicity study similar to OECD guideline 401, groups of male and female Chinese hamsters (5/sex) were given a single oral dose of the test substance in polyethylene glycol per gavage at dose levels of 4640, 6000 and 7750 mg/kg bw (Ciba-Geigy, 1978). Animals were then observed for 14 days. All animals gained weight throughout the study period. Slight sedation, dyspnoe and a curved body posture was observed in all dosing groups. All animals had recovered within 11 to 13 days. No mortality was observed and no gross internal lesions were observed during necropsy in any of the animals.A LD50 of greater than 7750 mg/kg bw was determined.
In the fouth acute oral toxicity study, groups of male and female rats (5/sex) were given a single oral dose of the test substance per gavage at dose levels up to 5000 mg/kg bw (BASF, 1969). Animals were then observed for 8 days. Due to the short summary of the study, information regarding clinical signs, mortality und gross necropsy is missing. Only a LD50 value of above 5000 mg/kg bw was determined.
Acute inhalation toxicity
In an acute inhalation study equivalent to OECD guideline 403, groups (9/sex) of RAI rats were exposed nose only to the test substance in ethanol (aerosol) for 4 hours at a maximum attainable concentration of 1700 mg/m3 (IBT, 1973). Animals were then observed for 8 days. After the 4-hour exposure the rats showed lateral position and apathy. Rats that were only treated with the vehicle did not show any toxic symptoms. All animals had recovered within 24 hours. No mortality and no gross internal lesions during necropsy were observed. A LC50 of greater than 1700 mg/m3 air was determined.
Acute dermal toxicity
In an acute dermal toxicity study equivalent to OECD guideline 402, groups of young adult New Zealand White rabbits (2/sex) were dermally exposed to a 50% suspension of the test substance for 24 hours at dose levels of 2500 and 10000 mg/kg bw. The skin of half of the animals was abraded before exposure. The animals were then observed for 8 days. No clinical signs were observed and the body weight gain was normal for all animals throughout the study period. No mortality and no gross internal lesions during necropsy were observed. Therefore a LD50 of above 10000 mg/kg bw was determined for both intact and abraded skin.
In a second acute dermal toxicity study, groups of 12 weeks old male and female Wistar rats (4/sex) were dermally exposed to the test substance in corn oil at a limit dose of 1000 mg/kg bw. Animals were then observed for 14 days. No mortality or any toxic signs were observed. No retardation of body weight gain was seen throughout the study period. A LD50 of greater than 1000 mg/kg bw was determined.
Conclusions
No deaths occurred when rats were exposed orally at doses above 5000 mg/kg bw, dermally at doses above 10000 mg/kg bw and by inhalation at doses of above 1700 mg/m3 air. Furthermore no severe clinical signs were observed during the studies. Although not necessary according to column 2 of REACH Annex VIII, part 8.5, the test substance proved its low acute toxicity in all three types of application.
Justification for selection of acute toxicity – oral endpoint
Worst case LD50 value with the most common animal species.
Justification for selection of acute toxicity – inhalation endpoint
Scientifically acceptable study report equivalent to OECD guideline 403.
Justification for selection of acute toxicity – dermal endpoint
Scientifically acceptable study report.
Justification for classification or non-classification
Dangerous Substance Directive (67/548/EEC)
The available studies are considered reliable and suitable for classification purposes under 67/548/EEC. As a result the substance does not need to be classified and labelled for acute toxicity (oral, dermal and inhalation) under Directive 67/548/EEC, as amended for the 31st time in Directive 2009/2/EC.
Classification, Labelling, and Packaging Regulation (EC) No 1272/2008
The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance does not eed to be classified and labelled for acute toxicity (oral dermal and inhalation) under Regulation (EC) No 1272/2008, as amended for the sixth time in Regulation EC No 605/2014.
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