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EC number: 226-408-0 | CAS number: 5395-50-6
- 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
LD50, oral, rat > 5000 mg/kg (mortality: 2/10)
LD50, i.p., mouse > 2000 mg/kg (mortality: 2/10)
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:
- 1978-1979
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- no
- Test type:
- fixed dose procedure
- Limit test:
- no
- Specific details on test material used for the study:
- test substance no. 78/15
administration of a solution, test substance dissolved in aqua dest. - Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Wiga
- Weight at study initiation: male animals 260 - 290 g, female animals 200 - 210 g
- Fasting period before study: 15 - 20 h before administration
- Diet (e.g. ad libitum): Herilan MRH-Haltung; Eggersmann KG - Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 50 % (w/v); 21.5 % (w/v)
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg body weight - Doses:
- 2150 mg/kg and 5000 mg/kg
- 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:
mortality: 1 h, 1 d, 2 d, 7 d and 14 d after administration
mean weight: beginning of test, 2 - 4 d, 7 d, 13 d
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, necropsy findings, mortality - Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: 2/10 dead animals
- Mortality:
- 20 % in high dose (2 dead male animals 1 day after administration),
no mortality observed in low dose - Clinical signs:
- other: piloerection and dyspnea in high dose group spastic gait, diarrhea, apathy and poor general state in both treatment groups
- Gross pathology:
- animals that died:
heart: acute dilatation, acute passive hyperemia
lungs: slight acute emphysema
stomach: dilated, glandular stomach, slightly reddened
intestines: atonic, vessels considerably injected
sacrificed animals:
organs: no abnormalities detected - Interpretation of results:
- GHS criteria not met
- Conclusions:
- It can be concluded that in this study the LD50 for the test substance is above 5.000 mg/kg body weight.
Reference
Table 1: LD50 determination
Doses [mg/kg] |
No. of animals |
Dead animals after 14 days |
Mortality [%] |
Doses used for calculating LD50 |
2.150 |
10 |
0 |
0 |
|
5.000 |
10 |
2 |
20.0 |
* |
Table 2: Mean weight
Dose [mg/kg] |
5.000 |
2.150 |
|
|
Mean weight [g] |
|
|
Male animals |
Beginning of test |
290 |
260 |
After 2 – 4 d |
314 |
287 |
|
After 7 d |
332 |
309 |
|
After 13 d |
359 |
329 |
|
Female animals |
Beginning of test |
210 |
200 |
After 2 – 4 d |
221 |
209 |
|
After 7 d |
229 |
222 |
|
After 13 d |
235 |
232 |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 5 000 mg/kg bw
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1978
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Remarks:
- pre-guideline study; inhalation hazard assay
- Qualifier:
- no guideline followed
- Version / remarks:
- Inhalation hazard test based on H.F. Smyth et al.: Am.Ind.Hyg.Ass.J. 23, 95 - 107 (1962)
- Principles of method if other than guideline:
- - Principle of test: inhalation of an atmosphere enriched with volatile components at 20 °C
- Short description of test conditions: for enrichment, 200 L air/h was conducted through a layer of 5 cm of the product
- Parameters analysed / observed: lethality, clinical signs, necropsy findings - GLP compliance:
- no
- Test type:
- fixed concentration procedure
- Species:
- rat
- Strain:
- not specified
- Sex:
- male/female
- Route of administration:
- inhalation: vapour
- Type of inhalation exposure:
- not specified
- Vehicle:
- air
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Source and rate of air: 200 L air/h
- Temperature in air chamber: 20 °C - Duration of exposure:
- 7 h
- Concentrations:
- app. 13mg/L
- No. of animals per sex per dose:
- 12 in total
(3 male and 3 female animals per experiment, 2 repetitions) - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs - Sex:
- male/female
- Dose descriptor:
- LC0
- Effect level:
- >= 13 mg/L air
- Exp. duration:
- 7 h
- Mortality:
- no mortality observed
- Clinical signs:
- other: During exposure: ragged breathing, wiping of snout, nasal secretion Directly after exposure: accelerated breathing, crusted noses in some animals or nasal secretion All signs had ceased by day 1 after exposure.
- Gross pathology:
- no abnormalities detected
- Interpretation of results:
- study cannot be used for classification
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
- Species:
- rat
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Interpretation of results:
- GHS criteria not met
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- secondary source without any other data
Additional information
Justification for classification or non-classification
The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance does not meet the criteria for classification and labelling for acute oral toxicity under Regulation (EC) No. 1272/2008.
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