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EC number: 500-734-6 | CAS number: 162492-01-5
- 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
Oral (OECD 423), rat: LD50 cut-off 5000 mg/kg bw
Dermal (OECD 402), rat: LD50 > 2000 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:
- 27 Jul - 18 Aug 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- adopted in 2001
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Version / remarks:
- adopted in 2008
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Version / remarks:
- adopted in 2002
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Bayerisches Landesamt für Gesundheit und Lebensmittelsicherheit, Schwabach, Germany
- Test type:
- acute toxic class method
- Limit test:
- yes
- Species:
- rat
- Strain:
- other: WISTAR Crl: WI(Han)
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River, Sulzfeld, Germany
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 9 - 10 weeks
- Weight at study initiation: 173 - 180 g (step 1), 157 - 166 g (step 2)
- Fasting period before study: yes
- Housing: groups in IVC cages, type III H, polysulphone cages, Altromin saw fibre bedding
- Diet: Altromin 1324 maintenance diet for rats and mice, ad libitum
- Water: tap water, sulphur acidified to a pH value of approximately 2.8
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 55 ± 10
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12 / 12 - Route of administration:
- oral: gavage
- Vehicle:
- other: polyethylene glycol 400
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 0.4 g/mL
- Amount of vehicle (if gavage): 5 mL/kg bw
- Justification for choice of vehicle: Several vehicles were evaluated and preparation and solubility tests were performed (corn oil, sterile water for injection, polyethylene glcol 400 (PEG 400) and 1% carboxymethylcellulose). Only the preparation with PEG 400 yielded a suspension which was considered to be applicable to animals.
- Lot/batch no.: S7106885 (Merck)
MAXIMUM DOSE VOLUME APPLIED: 5 mL/kg bw - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 3
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: animals were observed several times oin the day of dosing and daily thereafter; individual body weights were examined on day 1 (prior to the administration) and on days 8 and 15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, morbidity, mortality, body weight - Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occured during the study period.
- Clinical signs:
- No clinical signs of toxicity were observed up to the end of the 14-day observation period.
- Body weight:
- Body weight gains were within the normal ranges in females during the whole study period.
- Gross pathology:
- Necropsy examination revealed no substance-related findings.
- Interpretation of results:
- other: CLP/GHS criteria not met; no classification required according to Regulation (EC) No. 1272/2008
- Conclusions:
- CLP: not classified
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 5 000 mg/kg bw
- Quality of whole database:
- The available information comprises an adequate and reliable study (Klimisch score 1), and is thus sufficient to fulfil the standard information requirements set out in Annex VII, 8.5, of Regulation (EC) No 1907/2006.
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:
- 19 Jul 03 Aug 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- adopted in 1987
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Version / remarks:
- adopted in 2008
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Bayerisches Landesamt für Gesundheit und Lebensmittelsicherheit, Schwabach, Germany
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- other: WISTAR Crl: WI(Han)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River, Sulzfeld, Germany
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 7 - 8 weeks (males), 8 - 9 weeks (females)
- Weight at study initiation: 220 - 255 g (males), 211 - 220 g (females)
- Fasting period before study: no
- Housing: individual in IVC cages, Type III H, polysulphone cages on Altromin saw fibre bedding
- Diet: Altromin 1324 maintenance diet for rats and mice, ad libitum
- Water: tap water, sulphur acidified to a pH value of 2.8, ad libitum
- Acclimation period: at least five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 55 ± 10
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12 / 12 - Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: dorsal area of the trunk
- % coverage: approximately 10%
- Type of wrap if used: The test material was held in contact with the skin with a gauze-dressing and non-irritating tape. An additional dressing was used for fixation in a suitable manner.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Residual test material was removed with aqua ad iniectabilia.
- Time after start of exposure: 24 h
TEST MATERIAL
The test material was used as delivered. - Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg bw/day
- 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: animals were observed several times on the day of dosing and once daily thereafter; individual body weights were examined on day 1 (prior to the application) and on days 8 and 15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight - Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occured during the study period.
- Clinical signs:
- No clinical signs of toxicity were observed up to the end of the 14-day observation period.
- Body weight:
- Body weight gains were within the normal ranges in females during the whole study period.
- Gross pathology:
- Necropsy examination revealed no substance-related findings. Small testes and epididymides was observed in 1/5 male. This was an incidental finding and not considered to be test substance-related.
- Other findings:
- Erythema grade 1 was observed in 4/5 female animals and desquamation was observed in 1/5 female animals on study day 2. All signs of irritation were were reversible within 3 study days.
- Interpretation of results:
- other: CLP/GHS criteria not met; no classification required according to Regulation (EC) No. 1272/2008
- Conclusions:
- CLP: not classified
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- The available information comprises an adequate and reliable study (Klimisch score 1), and is thus sufficient to fulfil the standard information requirements set out in Annex VII, 8.5, of Regulation (EC) No 1907/2006.
Additional information
Reliable studies regarding acute oral and dermal toxicity are available for the test substance.
Oral:
The acute oral toxicity of the test substance was assessed in a study performed according to OECD Guideline 423 and in compliance with GLP (Holalagoudar, 2016). Two groups of three female WISTAR Crl: WI(Han) rats were treated with the test material at a dose level of 2000 mg/kg bw. The test material was administered in a single application by gavage formulated in polyethylene glycol 400 at a concentration of 0.4 g/mL and a dose volume of 5 mL/kg bw. The animals were observed for 14 days and body weights were measured. All animals were subjected to a necropsy and a macroscopic examination. No mortality was observed and treatment with the test substance did not cause any clinical signs during the observation period. Body weight and body weight gain of treated animals showed no indication of a treatment-related effect. There was no evidence of macroscopic observations at a dose level of 2000 mg/kg bw. Thus, under the conditions of this study, the acute oral LD50 value of the test substance was found to be > 2000 mg/kg bw in female Crl: WI(Han) rats. According to OECD Guideline 423 a LD50 cut-off value of 5000 mg/kg bw/day is specified since no animal died.
Dermal:
The acute dermal toxicity of the test substance was assessed in a study performed according to OECD Guideline 402 and in compliance with GLP (Holalagoudar, 2016). Five male and five female WISTAR Crl: WI(Han) rats were treated with the test substance by a single semi-occlusive dermal application at 2000 mg/kg bw. The animals were observed for 14 days and body weights were measured. All animals were subjected to a necropsy and a macroscopic examination. No mortality occurred and no clinical signs were observed. Signs of slight local irritation (erythema grade 1 in 4/5 females and desquamation in 1/5 female) were reversible within 3 days. There were no treatment related effects on body weight or body weight gain. There was no evidence of any observations at a dose level of 2000 mg/kg bw at necropsy. Thus, under the conditions of this study, the acute dermal LD50 value of the test substance was found to be > 2000 mg/kg bw in male and female Crl: WI(Han) rats.
Justification for classification or non-classification
The available data on acute oral and dermal toxicity do not meet the criteria for classification according to Regulation (EC) 1272/2008, and are therefore conclusive but not sufficient for classification.
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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