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EC number: 238-874-2 | CAS number: 14806-72-5
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 1999-07-21 to 1999-08-13
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study is the result of a structural analogue substance used as read-across substance. Study is conducted according to Guidelines in a GLP certified laboratory.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guidelineopen allclose all
- 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
Test material
- Reference substance name:
- -
- EC Number:
- 444-360-0
- EC Name:
- -
- IUPAC Name:
- 444-360-0
- Details on test material:
- - Physical state: Pale Yellow Liquid
- Stability under test conditions: Stable under storage conditions
- Storage condition of test material: At room temperature (17 - 23 degrees C) away from direct sunlight.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: RCC Ltd.,
Biotechnology & Animal Breeding Division,
CH-4414 Fullinsdorf,
Switzerland.
- Age at study initiation: Males: 8 weeks
Females: 10 weeks
- Fasting period before study: Overnight fasting prior to intubation
- Housing: Groups of three in MAkrolon type -4 cages with standard softwood bedding.
- Diet (e.g. ad libitum): Pelleted standard Kliba 3433, batch no. 37/99, rat maintenance diet.
- Water (e.g. ad libitum): Community tap water from Itingen
- Acclimatisation: 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±3°C
- Humidity (%): 40-70%
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12 hours dark / 12 hours light.
IN-LIFE DATES: From: July 21 -27, 1999 (Females) July 23 - 29, 1999 (males) To: August 11, 1999 (Females) August 13, 1999 (Males)
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: Bi-distilled water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 0.2g/ml
- Amount of vehicle (if gavage): 10 ml/kg
DOSAGE PREPARATION (if unusual): The test article was placed into a glass beaker on a tared Mettler balance and the vehicle was added. A weight by volume dilution was prepared using a magnetic stirrer as homogenizer. Homogenicity of the test article was in the vehicle was maintained during treatment.
The preparation was made shortly before each dosing. - Doses:
- 2000 mg/kg body weight
- No. of animals per sex per dose:
- 3 animals per sex. Only one dose (2000 mg/kg) was used.
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Mortality / viability: four times during test day 1 and once daily during days 2-15.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs: Changes in appearance and behaviour were examined four times during day 1 nad once daily during days 2-15
body weight: Animals were weighed on test day 1 (pre-administration), day 8 and day 15.
- Statistics:
- No statistical analysis was performed as no deaths occurred.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- No death occurred during the study.
- Clinical signs:
- other: No clinical signs were noted during the observation period.
- Gross pathology:
- No macroscopic findings were observed at necropsy.
Any other information on results incl. tables
Table 1: Individual Findings - Clinical Signs
Sex |
Animal No. |
Signs |
Test Day |
|||||||||||||||||
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
15 |
||||||
1h |
2h |
3h |
4h |
|||||||||||||||||
Female 2000 mg/kg |
1 |
No clinical signs |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2 |
No clinical signs |
|
|
|
|
|
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|
|
|
|
3 |
No clinical signs |
|
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|
|
|
|
Male 2000 mg/kg |
1 |
No clinical signs |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
2 |
No clinical signs |
|
|
|
|
|
|
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|
|
|
|
|
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|
|
|
|
|
3 |
No clinical signs |
|
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Table 2: Body Weights
Body Weight in grams |
||||
Sex |
Animal No. |
Day of Treatment |
Day 8 |
Day 15 |
Female 2000 mg/kg |
1 2 3 |
175.9 181.4 180.0 |
204.2 202.9 208.1 |
217.7 214.9 218.9 |
Male 2000 mg/kg |
1 2 3 |
206.7 211.7 211.1 |
264.8 260.1 258.3 |
289.6 286.4 275.8 |
Table 3: Macroscopic Findings
Sex |
Animal No. |
Type of death |
Findings |
Female 2000 mg/kg |
1 |
Scheduled necropsy |
No macroscopic findings |
2 |
Scheduled necropsy |
No macroscopic findings |
|
3 |
Scheduled necropsy |
No macroscopic findings |
|
Male 2000 mg/kg |
1 |
Scheduled necropsy |
No macroscopic findings |
2 |
Scheduled necropsy |
No macroscopic findings |
|
3 |
Scheduled necropsy |
No macroscopic findings |
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Remarks:
- Migrated information
- Conclusions:
- The LD50 of Read Across substance 1 (RA1) after single oral administration to rats of both sexes, observed over a period of 14 days was greater than 2000 mg/kg body weight.
- Executive summary:
The Read Across test substance RA1 was evaluated for its potential to produce death following oral administration at a dose of 2000 mg/kg in male and female Wistar rats.
Animals were administered a single dose of the test substance on a mg/kg bw basis by oral gavage following fasting for approximately 16.5 hours, but with free access to water. Three hours after dosing, the animals were returned to their cages and supplied with feed and water ad libitum.
No mortalities or clinical signs were observed during the study and the body weight of the animals was within the range commonly recorded for this strain and age.
Based on these results, the medial lethal dose (LD50) of RA after single oral administration to rats of both sexes, observed over a period of 14 days was greater than 2000 mg/kg body weight.
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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