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EC number: 406-200-8 | CAS number: 117827-06-2 COUPLER II; UC-136
- 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 1989, may 19th to 1989, june 7th
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study performed according to the Test Guidelines described in the EEC Directive 84/449/EEC.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- GLP compliance:
- yes
- Test type:
- fixed dose procedure
Test material
- Reference substance name:
- 3',5'-dichloro-4'-ethyl-2'-hydroxypalmitanilide
- EC Number:
- 406-200-8
- EC Name:
- 3',5'-dichloro-4'-ethyl-2'-hydroxypalmitanilide
- Cas Number:
- 117827-06-2
- Molecular formula:
- C24H39Cl2NO2
- IUPAC Name:
- N-(3,5-dichloro-4-ethyl-2-hydroxyphenyl)hexadecanamide
- Details on test material:
- Description : White powder
Purity : 98,5%
Instructions for
test article storage : At room temperature in the dark in a tightly sealed container
Stability of test article : Stable for one year maximal under storage conditions
Safety precautions : Gloves, goggies and face mask were sufficient to ensure personnel health and safety
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST SYSTEM
Test system Albino rats, Wistar (outbred, SPF—Quality)
Rationale Recognised by international guidelines as the
recommended test system (e.g. EPA, OECD, EEC).
Source Charles River Wiga, Sulzfeld, West—Germany
Number of animals 5 males, 5 females
Age at start of treatment Approx. 7 weeks
Body weight at start males: 193 — 225g
of treatruent females: 169 — 175g
Identification Earmark
Randomisation Randomly selected at the time of delivery in
groups of five.
Acclimatisation At least 5 days under laboratory conciitions.
HUSBANDRY
Room Number: 5
Standard Laboratory Conditions.
Air—conditioned with 7.5—15 air changes per hour, and hourly monitored
environinent with the temperature set at 21 ± 3°C, the relative humidity
30—70% (actual range: 60—80%) and 12 hours artificial fluorescent light /
12 hours dark per day.
Accommodation
Housed in groups of five per sex in polycarbonate cages containing purified
sawdust as bedding material (Woody Clean supplied by Broekman Institute,
Someren, The Netherlands).
Diet
Free access to standard pelleted laboratory animal diet (RMH—B from Hope
Farms, Woerden, The Netherlands). Certificates of analysis were examined
and are retained in the RCC NOTOX archives.
Water
Free access to tap—water. Certificates of analysis were examined and are
retained in the RCC NOTOX archives.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Details on oral exposure:
- VEHICLE
Vehicle : 1% aqueous methyl cellulose.
Stability of test substance in vehicle : Stable for at least 4 hours.
TEST SUBSTANCE PREPARATION
The formulations were prepared immediately prior to dosing. The test
substance was weighed into a glass flask on an analytical balance and the
vehicle (w/w) was added.
Homogeneity of the test substance in vehicle was obtained by a homogeniser.
TREATMENT
Method : Oral gavage
Fasting : Feed was withheld overnight prior to dosing until approximately 3—4 hours after administration of the test substance.
Frequency : Once, on day 1. - Doses:
- Dose level : 5000 mg/kg body weight.
Dose volume : 10 ml/kg body weight. - No. of animals per sex per dose:
- 5 males, 5 females
- Control animals:
- no
- Details on study design:
- Mortality / Viability : At periodic intervals on the day of dosing (day 1) and twice daily thereafter for at least 14 days.
Body Weights : Test days 1 (pre—administration), 8 and 15.
Symptoms : At periodic intervals on the day of dosing (day 1) and once daily thereafter.
All signs of reaction to treatment were recorded with particular attention paid to
changes in the skin, fur, eyes and mucous membranes, as well as to behaviour pattern,
tremors, convulsion, salivations, diarrhoea, lethargy, sleep and coma.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- UC—136 was administered to rats of both sexes by oral gavage at 5000 mg/kg
body weight.
No mortality occurred during the study period. - Clinical signs:
- other: There were no clinical signs of toxicity or behavioural changes over the 15 day observation period that were considered to be a result of treatment.
- Gross pathology:
- Macroscopic examination of all animals at termination did not reveal any
changes that were considered to have arisen as a result of treatment.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The oral LD50 value of UC—136 in rats of both sexes was estimated to exceed
5000 mg/kg body weight.
According to the general classification and labelling requirements for
dangerous substances (EEC Directive 83/467/EEC, Annex VI of the EEC
Directive 671548/EEC), UC—136 can not be classified and therefore should be
considered as non—harmful.
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