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EC number: 210-259-3 | CAS number: 611-20-1
- 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: LD50=500 mg/kg bw, female, rat, OECD 423, Wolf 2008
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:
- 2008-02-05 to 2008-02-20
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- no
- Species:
- rat
- Strain:
- other: Crl:CD(SD)IGS BR
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: approximately 8 weeks
- Weight at study initiation: 170 - 190 g
- Fasting period before study: overnight, until 3 hours post application
- Housing: optimal hygienic conditions (OHC), single caging in Makrolon type III cages
- Diet: ad libitum, Ssniff R/M-H Maintenance diet for rats and mice (item V1534-3)
- Water: communal drinking water from automated watering system, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22.7 (average, continuous monitoring)
- Humidity (%): 49.6% (average, continuous monitoring)
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12 / 12
IN-LIFE DATES: From: 2008-02-05 To: 2008-02-20 - Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Remarks:
- 0.1% aqueous solution, plus Tween 80
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 15 and 100 mg/mL, suspension
- Amount of vehicle (if gavage): 20 mL/kg body weight
- Justification for choice of vehicle: test substance insoulble in water, CMC plus Tween is a common vehicle for oral toxicity testing
MAXIMUM DOSE VOLUME APPLIED: 20 mL/kg body weight
DOSAGE PREPARATION (if unusual): suspension
CLASS METHOD
- Rationale for the selection of the starting dose: No prior information on toxicity was available. in accordance with the guideline, a starting dose of 300 mg/kg bw was chosen. - Doses:
- 300 and 2000 mg/kg body weight (bw)
- No. of animals per sex per dose:
- 3, that is:
- step 1, 300 mg/kg bw: 3 females
- step 2, 300 mg/kg bw: 3 females
- step 3, 2000 mg/kg bw: 3 females - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: Applicarion day: 0-0.5, 0.5-1, 1-2, 2-4, and 4-6 hours post administration
- Frequency of weighing: before administartion, day 7, day 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight - Statistics:
- none, decision tree of the OECD guideline used
- Sex:
- female
- Dose descriptor:
- LD0
- Effect level:
- 300 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: 2 groups of 3, totally 6 animals
- Sex:
- female
- Dose descriptor:
- LD100
- Effect level:
- 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: 3 animals
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 500 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: Reported in full study report as 300
- Mortality:
- 300 mg/kg bw: 0/6
2000 mg/kg bw: 3/3 (within 10 - 20 minutes post application) - Clinical signs:
- other: 300 mg/kg bw: signs of reduced well-being (unspecific, such as sedation, apathy, piloerection, hunched posture, or closed eyes, in single or multiple occurrence), until 6 h post application 2000 mg/kg bw: all deaths occurred before first observation
- Gross pathology:
- No abnormal findings in survivors (300 mg/kg bw).
Glandular stomach, mucosa: pseudomembranes in animals dying on test within 20 minutes (2000 mg/kg bw) - Other findings:
- - Potential target organs: gastrointestinal tract
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- The study is considered to be reliable and adequate. Comparison of the decision tree in Regulation (EC) No. 440/2008, B.1 tris, Appendix 1C, with the raw data indicated that LD50=500mg/kg bw, and not the reported range 300-500mg/kg bw.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 500 mg/kg bw
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
Only a single acute oral toxicity study conducted according to method B.1 tris (OECD guideline 423) and under GLP was available. No deaths were reported at 300mg/kg bw, whereas there were no survivors reported at 2000mg/kg bw. Shock from gastrointestinal lesions was proposed to be the cause of death. The LD50in female rats was reported as between 300 and 500 mg/kg bw, however, comparison of the decision tree in Regulation (EC) No. 440/2008, B.1 tris, Appendix 1C, with the raw data indicated that LD50=500mg/kg bw. This has no effect on classification and labelling, nor risk assessment.
The study is considered to be relevant, reliable (Klimisch 1) and adequate for the purposes of risk assessment, classification and labelling.
Justification for selection of
acute toxicity – oral endpoint
Valid study in compliance with OECD testing guideline and GLP
Justification for classification or non-classification
The key value selected for the acute oral toxicity, LD50=500 mg/kg bw leads to classification of the substance as Category 4, H302, Harmful if swallowed, according to the criteria in Regulation (EC) No. 1272/2008, Annex I, Part 3, 3.1.2.
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