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EC number: 265-479-2 | CAS number: 65122-08-9
- 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 LD50 is based on a substance that contains 26% acetic acid (LD50 > 2000 mg/kg bw), 20.4% acetic anhydride (LD50 630 mg/kg bw). The LD50 as available there needs to be correct for at least these two components.
This is done with a reversed ATE calculation
males:
(100 -67)/243=26/2000 + 20.4/630 + 20.7/ATE --> this leads to an ATE of 230 mg/kg bw for BR12
females
(100 -67)/154=26/2000 + 20.4/630 + 20.7/ATE --> this leads to an ATE of 122 mg/kg bw for BR12
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:
- 1980-1981
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- non GLP
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Winkelmann Borchen
- Strain: Wistar TNO W4
- Females nulliparous and non-pregnant:no data
- Age at study initiation: males 9 weeks; females 14 weeks
- Weight at study initiation: males: 135-198 g; females: 152-183 g
- Fasting period before study: not mentioned
- Housing: 5/sex/cage in Macrolon type III cages
- Diet: Altromin 1324 (Altromin GmbH, Lage) ad libitum)
- Water: tap water ad libitum
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22± 1,5 °C
- Humidity (%): 60 ± 5 %
- Air changes (per hr): not indicated
- Photoperiod (hrs dark / hrs light): 12/12
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Doses:
- males: 0.1, 0.2, 0.25, 0.45 and 0.5 mL/kg bw
females: 0.05, 0.08, 0.1, 0.2, 0.3 and 0.5 mL/kg bw - No. of animals per sex per dose:
- 10/sex/dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: several time on day 1 and 2 times daily thereafter (with the exception of weekend days 1 time)
- Body weight: on day 1, 7 and 14:
- Necropsy of survivors performed: yes of all animals
- Statistics:
- probit analysis
- Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 0.213 mL/kg bw
- Based on:
- test mat.
- 95% CL:
- >= 0.164 - <= 0.261
- Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 243 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: calculated based on density
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 0.135 mL/kg bw
- Based on:
- test mat.
- 95% CL:
- >= 0.1 - <= 0.184
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 154 mg/kg bw
- Remarks on result:
- other: calculation based on density
- Mortality:
- males: 0/10, 5/10, 7/10, 9/10 and 10/10 at 0.1, 0.2, 0.25, 0.45 and 0.5 mL/kg bw
females: 0/10, 2/10, 6/10, 6/10, 8/10 and 10/10 at 0.05, 0.08, 0.1, 0.2, 0.3 and 0.5 mL/kg bw
Deaths from 2 hours post dosing onwards - Clinical signs:
- general poor condition, sedation and ruffled fur at 0.2 mL/kg and above in males and at 0.08 mL/kg and above in females (ruffled fur at 0.1 and above in females)
- Body weight:
- severe decrease in body weight at and above 0.2 mL/kg in males and at and above 0.1 mg/kg in females
- Gross pathology:
- no findings in decedents and survivors
- Interpretation of results:
- Category 3 based on GHS criteria
- Conclusions:
- The LD50 of the substance tested is 154 mg/kg bw
- Executive summary:
In an acute oral toxicity tests male and female Wistar rats received the substances at 0.1, 0.2, 0.25, 0.45 and 0.5 mL/kg bw or 0.05, 0.08, 0.1, 0.2, 0.3 and 0.5 mL/kg bw, respectively. Mortality and severe body weight loss were seen in males at 0.2 mL/kg and above and in females at 0.08 -0.1 mL/kg and above. Clinical signs reported included a general poor condition, sedation and ruffled fur. The LD50 in males is 243 mg/kg bw and in females 154 mg/kg bw. The substance needs to be classified as toxic (H301).
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 122 mg/kg bw
Additional information
Justification for classification or non-classification
Based on the available information the substance needs to be classified according to Ragulation (EC) No 1272/2008 as H301 (toxic if swallowed).
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