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EC number: 230-990-1 | CAS number: 7396-58-9
- 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
Endpoint summary
Administrative data
Description of key information
The acute oral toxicity of the substance was assessed using:
- an acute oral toxicity test performed in rats according to OECD 423 guideline and Good Laboratory Practices (Pelcot, 2010)
The substance is of moderate acute toxicity following oral exposure:
The oral LD50 was comprised between 300 and 2000 mg/kg bw in rats.
Key value for chemical safety assessment
Acute toxicity: via oral route
Endpoint conclusion
- Dose descriptor:
- LD50
Additional information
In the study of Pelcot (CIT 2010a), the acute oral toxicity of the test item was evaluated in rats according to OECD (No. 423, 17th December 2001) and Commission Regulation (EC) (No. 440/2008, B.1tris, 30 May 2008) guidelines. The study was conducted in compliance with the principles of Good Laboratory Practice Regulations.
The test item was prepared in corn oil and was administered by oral route (gavage), under a volume of 10 mL/kg, to groups of three fasted female Sprague-Dawley rats.The study design was as follows: The starting dose-level was 300 mg/kg bw. As no deaths occured, another assay was carried out on 3 animals at 2000 mg/kg bw . After this second assay as 1/3 animals died, the results were confirmed in 3 other animals at the dose-level of 2000 mg/kg bw. As all animals died in the third assay , another assay was carried out at 300 mg/kg bw.
At each step, clinical signs, mortality and body weight gain were checked for a period of up to 14 days following the single administration of the test item. All animals were subjected to necropsy.
At dose-level of 300 mg/kg: first step (three females): No mortality and no clinical signs were noted at this dose-level.When compared to CIT historical control data, the body weight gain of the animals was not affected by treatment with the test item.At necropsy, no apparent abnormalities were observed in any animal.
Atdose-level
of 2000 mg/kg: first step (three females):One
female was found dead on day 6. Hypoactivity, piloerection, tremors,
hypersensitivity to the touch, exophthalmia and rhinorrhea were noted
prior to its death. In the surviving animals, hypoactivity or sedation,
piloerection, tremors, dyspnea, exophthalmia, rhinorrhea, ocular
secretion, hypersensitivity to the touch and ataxia were noted between
day 3 and day 7 or 9.A body weight loss (-8%) was noted in 1/2 surviving
animals between day 1 and day 8. When compared to CIT historical control
animals, a lower body weight gain (vs. 41 ±in control data base)
was observed in the other female between day 1 and day 8. In both
animals, the body weight gain returned to normal between day 8 and day
15.At necropsy, no apparent abnormalities were observed in any animal.
In
the second step (confirmation on three other females):Two
females were found dead (day 3; day 4). Piloerection, hypoactivity and
dyspnea were noted prior to the death (day 4) of only one of them. No
clinical signs were observed before death of the other
female.Piloerection, hypoactivity then sedation, dyspnea, cold to the
touch and body weight loss (-26%) was observed in the third female.
According to the severe clinical signs observed, this animal was
sacrificed on day 8 for ethical reasons.At necropsy, no apparent
abnormalities were observed in any animal.
At dose-level of 300 mg/kg: second step (confirmation on three other females): No mortality and no clinical signs were observed at this dose-level.When compared to CIT historical control data, a lower body weight gain (vs. 15 ±in control data base) was noted in 1/3 females between day 8 and day 15.At necropsy, no apparent abnormalities were observed in any animal.
Under these experimental conditions, the oral LD50of the test item was comprised between 300 and 2000 mg/kg in rats.
Justification for classification or non-classification
According to the criteria laid down in EU regulation (EC) n° 1272/2008/EC (CLP), the substance is classified in category 4 of toxicity with the hazard statement H302.
The corresponding classification according to the EU directive67/548/EEC is Harmful with the risk phrase R22.
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