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Diss Factsheets
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EC number: 273-453-7 | CAS number: 68966-86-9
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Endpoint summary
Administrative data
Description of key information
In an acute oral study, Sprague-Dawley rats were exposed to a single dose of the test item (1429, 2000, 2800 and 3920 mg/kg bw) via oral gavage. Acute toxicological symptoms attributed to the test item were observed, however, no macroscopic organ changes were detected in pathological examinations post-mortem. Fifty percent mortality was not observed at any tested dose level, however, due to the unexpectedly low mortality at the high dose, the LD50 value was not statistically quantifiable. The authors suggest a projected LD50 value of >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:
- 28 April 1994 - 27 October 1994
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Justification for type of information:
- Fully adequate for assessment. Conducted according to OECD TG 401 Acute Oral Toxicity, which was removed from the OECD Test Guidelines Programme in 2001, the GLP compliant study is considered reliable according to OECD 420, EU B.1bis (Commission directive 2004/73/EC).
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- Adopted February 24, 1987
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Sprague-Dawley Albino rats breeded by commericial supplier
- Age at study initiation: not stated. OECD TG 401 required use healthy young adult animals
- Veterinary preliminary examination: without morbid signs; females were nulliparous and non-pregnant
- Body Weight (bw) at study initiation: female bw 203g (range: 194-211g); male bw 206g (range: 188-237g).
- Body Weight (bw) variation: females 95-103% the mean bw; males 91-115% the mean bw (< ±20% bw variation)
- Fasting period before study: overnight before the day of administration
- Housing: Housed individually in Macrolon cages (area 800 cm2, height 17 cm)
- Diet: commerical diet, twice 8g daily
- Water: ad libitum
- Acclimation period: 5 days prior to the administration
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 – 23 ºC
- Humidity (%): 30 - 70%
- Air changes (per hr): not stated
- Photoperiod (hrs dark / hrs light): 12:12 - Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: undiluted
- Amount of vehicle (if gavage): not stated
- Purity: not stated
MAXIMUM DOSE VOLUME APPLIED: not stated; the test material was administered undiluted - Doses:
- The test substance was orally administrated as a single dose to four groups. The dose ranges were: Group I 1429 mg/kg bw; Group II 2000 mg/kg bw; Group III 2800 mg/kg bw; and Group IV 3920 mg/kg bw. Doses are expressed as weight (mg) per unit weight of the test animal (kg bw).
- No. of animals per sex per dose:
- Group I (1429 mg/kg bw) 5 females (n=5)
Group II (2000 mg/kg bw) 5 females and 5 males (n=10)
Group III (2800 mg/kg bw) 5 females and 5 males (n=10)
Group IV (3920 mg/kg bw) 5 males (n=5) - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: two observations on the day of administration (5 minutes and 4 hours), followed by daily observations
- Necropsy of survivors performed: yes
- Judgement: mortality, LD50, body weight, behaviour, toxicological symptoms and pathological examination
- Other examinations performed: clinical signs (apathy, feed refusal, ruffled fur, motor activity, body rigidity, hunched posture) , body weight and histopathology. - Statistics:
- As the dose-response relationship was non-linear the LD50 value was not quantifiable according to the Litchfield and Wilxocon (1949) or Shayne and Weil (1984) methods, as 50% mortality was not observed. The LD50 was stated as >2000 mg/kg bw.
- Key result
- Sex:
- male/female
- Dose descriptor:
- approximate LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- The LD50 value was unquantifiable due to the non-linear dose relationship of the mortality observed. The authors suggested that the mortality rate is greater than 2000 mg/kg bw.
- Clinical signs:
- other: Acute toxicological symptoms were observed in 3 rats dosed with 1429 mg/kg bw, in 3 rats dosed with 2000 mg/kg bw and in all rats dosed with the higher dose groups (2800 mg/kg bw and 3920 mg/kg bw).
- Gross pathology:
- No macroscopical organ changes were detected in the pathological examination of any dose groups (1429, 2000, 2800 or 3920 mg/kg bw).
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The oral LD50 value is greater than 2000 mg/kg bw. There was no evidence of intrinsic acute oral toxicity requiring classification or substance specific risk mitigation measures (RMM).
- Executive summary:
Sprague-Dawley rats were exposed to a single dose of the test item via oral gavage at 1429 mg/kg bw (n=5), 2000 mg/kg bw (n=10), 2800 mg/kg bw (n=10) and 3920 mg/kg bw (n=5). Acute toxicological symptoms attributed to the test item were observed in 3/5 rats dosed with 1429 mg/kg bw, 3/10 rats receiving 2000 mg/kg bw and in all rats dosed with >2800 mg/kg bw (15/15). No macroscopic organ changes were detected in pathological examinations post-mortem. Fifty percent mortality was not observed at any tested dose level, consequently, the LD50 value was not quantifiable according to the statistical methods of Litchfield & Wilcoxon (1949) or Shayne & Weil (1984). The authors suggested a value >2000 mg/kg bw.
Litchfield JT, Wilcoxon F (1949) J. Pharmaol. Exp. Ther. 96: 99-113.
Shayne CG & Weil CS (1984) Principles and Methods of Toxicology, Raven Press, New York.
Reference
The mortality observed in the study is shown in the table below.
Group | I (1429 mg/kg bw) | II (2000 mg/kg bw) | III (2800 mg/kg bw) | IV (3920 mg/kg bw) |
Mortality male |
not tested |
1 (1/5) |
2 (2/5) |
1 (1/5) |
Mortality female |
0 (0/5) |
2 (2/5) |
0 (0/5) |
not tested |
Total mortality |
0 (0/5) |
3 (3/10) |
2 (2/10) |
1 (1/5) |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- Reliable, adequate and relevant data available to fulfil the tonnage-driven data requirements of REACH.
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
Justification for classification or non-classification
An assessment of acute toxicity is required to fulfil REACH Annex VII information requirements. The acute oral toxicity study was conducted according to OECD TG 401, which was removed from the OECD Test Guidelines Programme in 2001. The GLP compliant study is considered reliable without restriction (Klimisch 1) and equivalent to OECD 420, EU B.1bis (Commission directive 2004/73/EC). Fifty percent mortality was not observed at any tested dose level, and the LD50 was expected to be >2000 mg/kg. There is no evidence of a relevant intrinsic acute oral toxicity requiring classification or substance specific risk mitigation measures (RMM).
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.
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