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EC number: 254-663-8 | CAS number: 39872-57-6
- 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 401), rat: LD50: > 2000 mg/kg bw (limit test)
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:
- 22 Aug - 13 Sep 1995
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- 24 Feb 1987
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Version / remarks:
- EEC directive 92/69/EEC (July 31, 1992)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Niedersächsisches Umweltministerium, Hannover, Germany
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- other: Hsd/Cpb:WU
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Females nulliparous and non-pregnant: not specified
- Weight at study initiation: 230 - 252 g (males) and 155 - 171 g (females)
- Fasting period before study: 16 h before administration and 3 -4 h after administration
- Housing: up to 5 animals per cage per sex, in Makrolon type III cages on LIGNOCEL bedding
- Diet: pelleted rat diet (Ssniff R-Alleindiät, Ssniff Spezialdiäten GmbH, Soest, Germany), ad libitum
- Water: drinking water, ad libitum
- Acclimation period: 6 days (range-finding study), 7 days (main study, females), 14 days (main study, males)
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12/12
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 2.11 mL/kg bw
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- Range-finding test: 2 females
Main study: 5 males and 5 females - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were examined 10 min, 1 h, 2 h, 6 h and 24 h after treatment and thereafter once daily up to Day 14. Body weights were recorded immediately before treatment (Day 0) and on Days 7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathology - Preliminary study:
- No mortility occured in the range-finding test.
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- 1/5 males and 0/5 females died
- Clinical signs:
- other: slight diarrhea in 5/5 males 24 h after treatment, fully reversible on Day 3; slight squatting position and slight piloerection in 1/5 female 24 h after treatment, fully reversible within 48 h.
- Gross pathology:
- In the animal found dead, test substance related findings of extreme redness of the gastric mucous membrane was observed.
In surviving animals, an adhesion of the stomach to other organs was found, mainly to the spleen which was enlarged in most animals. Additionally, particles of probably separated and indurated tissue portions were observed in the stomach. - Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008
- Conclusions:
- In this acute oral toxicity study in male and female rats a LD50 value of > 2000 mg/kg bw was found.
Reference
Table 1. Results of the acute oral toxicity study in rats.
Dose level (mg/kg bw) |
Mortalities |
Clinical signs |
males |
||
2000 |
1/5 |
5/5 |
females |
||
2000 |
0/5 |
1/5 |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Quality of whole database:
- The available information comprises an adequate and reliable study, and is thus sufficient to fulfil the standard information requirements set out in Annex VIII, 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
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
The acute oral toxicity of the test substance was assessed in a study according to OECD Guideline 401 and in compliance with GLP (1995). In this study, 1/10 animals died at 2000 mg/kg bw. Clinical signs of slight diarrhea were observed in 5/5 males 24 h after treatment, fully reversible on Day 3. Additionally, slight squatting position and slight piloerection were observed in 1/5 females 24 h after treatment, fully reversible within 48 h.Thus, a LD50 of > 2000 mg/kg bw was derived.
Justification for classification or non-classification
The available data on acute oral 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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