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EC number: 851-742-4 | CAS number: 464207-51-0
- 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 toxicity: oral: LD50 > 2000 mg/kg bw (read-across, OECD 401, GLP, K, rel. 1).
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
Further information is included as attachment to section 13.
1. HYPOTHESIS FOR THE ANALOGUE APPROACH
This read-across is based on the hypothesis that source and target substances have similar physico-chemical, (eco)toxicological and environmental fate properties because of their structural similarity.
2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
The target substance is one of the constituents of the source substance, together with isomers: the target substance is a mono-constituent, individual optical isomer, while the source substance is defined as a multi-constituent, with three pairs of racemate.
3. ANALOGUE APPROACH JUSTIFICATION
The source substance and the target substance are isomers. Based on structural and physico-chemical similarities, it is considered appropriate to read-across data from the source substance.
No toxicity was observed in the Acute Oral Toxicity test performed on the source substance.
The study design (OECD 401, GLP) is adequate and reliable for the purpose of the prediction based on read-across. The test material used represents the source substance as described in the hypothesis in terms of purity and impurities. The results of the studies are adequate for the purpose of classification and labelling.
Therefore, based on the considerations above, it can be concluded that the result of the Acute Oral Toxicity test conducted with the source substance is highly likely to predict the properties of the target substance and is considered as adequate to fulfil the information requirement of Annex VII, 8.5.1.
4. DATA MATRIX
Cf. attachment to section 13. - Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across: supporting information
- Preliminary study:
- not applicable
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD0
- Effect level:
- >= 2 000 mg/kg bw
- Based on:
- test mat.
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No death occurred throughout the study
- Clinical signs:
- other: No clinical signs were observed throughout the study
- Gross pathology:
- The necropsy findings were consistent with the background macroscopic pathology of this strain of rats:
- Urinary bladder: contained white waxy plug in 1M
- Left eye: appeared small, palpebral fissure reduced in size in 1M
- Uterus: minimally distended with fluid in 1F - Other findings:
- None
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Oral LD50Combined > 2000 mg/kg bw
- Executive summary:
In a limit acute oral toxicity study performed according to the OECD test guideline No. 401 and in compliance with GLP, groups of fasted, 5-7 weeks old, Crl:CD(SD) rats (5/sex) were administered a single oral dose of the source substance at 2000 mg/kg bw by gavage. The animals were observed for mortality, clinical signs and body weight for 14 days and then necropsied for macroscopic observations.
No mortality and no clinical signs were observed throughout the study. There was no adverse effect on bodyweight gain. No abnormality was revealed at autopsy.
Oral LD50Combined > 2000 mg/kg bw
Under the test conditions, the source substance, is not classified according to the Regulation EC No. 1272/2008 (CLP) and to the GHS. The same conclusion applies to the target substance.
This study is considered as acceptable and satisfies the requirement for acute oral toxicity endpoint.
Read-across justification is attached to Iuclid section 13.
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 1991-07-11 to 1991-07-25
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Study performed according to OECD test guideline No. 401 and in compliance with GLP.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- During the acclimation period the temperature rose above the range 19-25°C on several occasions, a maximum temperature of 33°C being recorded on one occasion.
- Principles of method if other than guideline:
- not applicable
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- UK GLP (inspection date: 1990-06-19 / signature date: 1990-10-05)
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- other: Crl:CD(SD)BR strain (VAF plus)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River (UK) Limited, Margate Kent
- Age at study initiation: 5-7 weeks
- Weight at study initiation: M: 110 to 129 g; F: 119 to 127
- Fasting period before study: overnight before dosing
- Housing: in groups of 5, by sex, in grid bottomed cages suspended over cardboard lined excreta trays
- Diet: pelleted diet ad libitum (SQC rat and mouse maintenance No. 1 expanded, produced by Special Diets Services, Witham, Essex).
- Water: ad libitum
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25 °C/ During the acclimatisation period the temperature rose above this range on several occasions, a maximum temperature of 33°C being recorded on one occasion.
- Humidity (%): 42-62 %
- Air changes (per hr): no data
- Photoperiod: 12 hrs dark / 12 hrs light
IN-LIFE DATES: no data - Route of administration:
- oral: gavage
- Vehicle:
- polyethylene glycol
- Remarks:
- PEG 400
- Details on oral exposure:
- VEHICLE
- Amount of vehicle (if gavage): 10 mL/kg bw
- Justification for choice of vehicle: not justified
- Lot/batch no. (if required): no data - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5 animals/sex/dose
- Control animals:
- no
- Details on study design:
- - Assess to food was permitted immediately after dosing
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Clinical signs: approximately 30 minutes, 1, 2 and 4 hours afters dosing and thereafter for 14 consecutive days.
Weighing: on the day of dosing, on days 8 and 15.
- Necropsy of survivors performed: yes, including opening of the thoracic and visceral cavities, opening and examination of the stomach and representative sections of the gastro-intestinal tract and examination of the major organs. Abnormal tissues and organs were preserved in buffered formol saline. - Statistics:
- not done
- Preliminary study:
- not applicable
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD0
- Effect level:
- >= 2 000 mg/kg bw
- Based on:
- test mat.
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No death occurred throughout the study
- Clinical signs:
- other: No clinical signs were observed throughout the study
- Gross pathology:
- The necropsy findings were consistent with the background macroscopic pathology of this strain of rats:
- Urinary bladder: contained white waxy plug in 1M
- Left eye: appeared small, palpebral fissure reduced in size in 1M
- Uterus: minimally distended with fluid in 1F - Other findings:
- None
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Oral LD50Combined > 2000 mg/kg bw
- Executive summary:
In a limit acute oral toxicity study performed according to the OECD test guideline No. 401 and in compliance with GLP, groups of fasted, 5-7 weeks old, Crl:CD(SD) rats (5/sex) were administered a single oral dose of 2000 mg test material/kg bw by gavage. The animals were observed for mortality, clinical signs and body weight for 14 days and then necropsied for macroscopic observations.
No mortality and no clinical signs were observed throughout the study. There was no adverse effect on bodyweight gain. No abnormality was revealed at autopsy.
Oral LD50Combined > 2000 mg/kg bw
Under the test conditions, the test material is not classified according to the Regulation EC No. 1272/2008 (CLP) and to the GHS.
This study is considered as acceptable and satisfies the requirement for acute oral toxicity endpoint.
Referenceopen allclose all
No other information
No other information
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- The key study is GLP compliant and of high quality (Klimisch score = 1).
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
Acute toxicity: oral
A key study was identified on a source substance (Safepharm, 1992, Klim.1). In this limit acute oral toxicity study performed according to the OECD test guideline No. 401 and in compliance with GLP, rats were administered a single oral dose of 2000 mg/kg bw by gavage.
No mortality and no clinical signs were observed throughout the study. There was no adverse effect on bodyweight gain. No abnormality was revealed at autopsy.
Oral LD50 Combined > 2000 mg/kg bw
(see Iuclid section 13 for read-across justification).
Justification for classification or non-classification
Harmonised classification:
The substance has no harmonised classification according to the Regulation (EC) No. 1272/2008 (CLP).
Self classification:
Acute toxicity (Oral):
Based on read-across data, the substance is:
- not classified according to the CLP as the LD50 is higher than 2000 mg/kg bw
- not classified according to the GHS as the LD50 is higher than 2000 mg/kg bw and the substance does not meet the specific criteria for the Category 5 defined in the GHS.
Acute toxicity (Dermal):
No information was available.
Acute toxicity (Inhalation):
No information was available.
Specific target organ toxicity: single exposure (Oral):
The classification criteria according to the CLP and to the GHS as specific target organ toxicant (STOT) – single exposure, oral are not met since no reversible or irreversible adverse health effects were observed immediately or delayed after exposure and no effects were observed at the guidance value (oral) for a Category 1 classification (C≤ 300 mg/kg bw) and at the guidance value (oral) for a Category 2 classification (2000 mg/kg bw≥C > 300 mg/kg bw). No classification is required.
The criteria for Transient Organ effects (STOT-SE Category 3) according to the CLP and to the GHS are not met since narcotic effects were not observed in the acute oral toxicity study.
Specific target organ toxicity: single exposure (Dermal):
No information was available.
Specific target organ toxicity: single exposure (Inhalation):
No information was available.
Aspiration hazard:
The substance is not a hydrocarbon and no effects were observed on lungs in oral study, therefore the criteria for aspiration toxicity according to the CLP and to the GHS are not met.
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