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EC number: 404-740-9 | CAS number: 115895-09-5
- 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:
- experimental study
- Adequacy of study:
- key study
- Study period:
- from November 28th, 1988 to December 12th, 1988
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study performed according to OECD Guidelines for testing of chemicals (no 401)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1989
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 404-740-9
- EC Name:
- -
- Cas Number:
- 115895-09-5
- Molecular formula:
- C26H40Cl2O5
- IUPAC Name:
- ethyl 3,5-dichloro-4-{[(hexadecyloxy)carbonyl]oxy}benzoate
- Details on test material:
- A 500g sample of the test substance was received from the sponsor on September 19, 1988. It was a white powder, designated AF-366"
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Wistar outbred (Bor:WISW)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Test animals
Mult, about 16 weeks old, albino rats were used. They ware Wistar outbred
rats (Bor:WISW) obtained from a colony, maintained under SPF—conditions at
the Breeding Centre for Laboratory Animals, F. Winkelmann GmbH, Borchen,
F.R. Gerinany. The body weights of the males varied from 308 to 354 g, those
of the females from 182 to 202 g. The animals ware kept under the
environmental conditions of the Institute’s animal house for about 13 weeks
prior to the test.
Housing and maintenance
The rats ware housed in groups of f ive, males and females separated, in
stainless steel cages with wire—screen bottom and front, in a room
ventilated with about 10 air changes per hour and maintained at 20—24°C.
Relative humidity was regulated between 40 and 70 per cent, lighting was
artificial by fluorescent tubes, time switch—controlled at a sequence of
12 hours light, 12 hours dark. Tap water was freely available at all times
by means of an automatic watering system. The rats had free access to the
Institute’s cereal—based, open—formula diet for rats and mice,
except in the overnight period before dosing tili 4 hours after dosing,
when food was withheld. The diet is analyzed regularly for nutrients and
contaminants. Tap water is analyzed regularly for
contaminants.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- maize oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 25%
- Amount of vehicle (if gavage): 20 mL/kg bw
- Justification for choice of vehicle: maize oil was selected as it was shown to be an appropriate vehicle in a pre-test study
MAXIMUM DOSE VOLUME APPLIED: 20 mL/kg bw - Doses:
- one single dose of 20.0 ml per kg body weight
This dose level is equal to 5000mg test substance per kg body weight - No. of animals per sex per dose:
- 5 males and 5 females
- Control animals:
- no
Results and discussion
- Preliminary study:
- A preliminary study was carried out to find an appropriate vehicle and the
general level of acute toxicity of the test substance.
After these preliminary observations, the substance was given by gavage as
a 25% (w/v) suspension in maize oil, in one single dose of 20.0 ml per kg
body to 5 males and 5 females. This dose level is equal to 5000 mg test
substance per kg body weight. 1f a dose level of 5000 mg/kg or more does
not cause compound—related mortality, then a full study with various dose
levels is not required (OECD—Guidelines for Testing of Chemicals).
The rats were observed frequently for signs of intoxication, during the
first 4 hours after treatment and thereafter, at least once daily
throughout an observation period of 14 days. The individual body weights of
the rats were recorded on day 0, 3, 7 and 14. At the end of the observation
period, the rats were killed and examined grossly.
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- >= 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No deaths occured and all rats looked quite heathly throughout the remaining part of the 14-day observation period
- Clinical signs:
- other: Except signs of sluggishness and piloerection during the first few hours after treatment no signs of intoxication were observed
- Gross pathology:
- Macroscopic examination of the rats at the termination of the study
revealed a mottled surface of one of the kidneys in one male and one
female. No other treatment—related gross alterations were found.
At necropsy, 1/5 males and 1/5 females had a mottled surface of one kidney, which is not considered to be substance-related. No other gross abnormalities were observed.
Any other information on results incl. tables
Table 1: Mortality and clinical signs
Dose |
Toxicological results* |
Duration of clinical signs |
Time of death |
Mortality (%) |
Males |
||||
5000 |
0/5/5 |
1-24 h |
- |
0 |
Females |
||||
5000 |
0/5/5 |
1-24 h |
- |
0 |
Overall LD50 > 5000 mg/kg bw |
* first number = number of dead animals
second number = number of animals with systemic clinical signs
third number = number of animals used
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- From the mortality figures, the oral LD50 of “AF—366” was found to exceed
5000 mg per kg body weight, both for male and for female rats. Therefore,
the test substance can be classified as unharmful (EC—directive 83/467/EEC,
Official Journal of the European Communities, L 257, September 16, 1983).
Not classified.
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