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EC number: 947-975-7 | CAS number: -
- 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: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 17 November 1997 to 28 January 1998
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: EEC 92/69
- Version / remarks:
- study was performed to obtained information about evaluation of toxicity effect in accordance to EEC 92/69.
- GLP compliance:
- not specified
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- tridecyl 2-hydroxybenzoate
- EC Number:
- 947-975-7
- Molecular formula:
- C20H32O3
- IUPAC Name:
- tridecyl 2-hydroxybenzoate
Constituent 1
- Specific details on test material used for the study:
- Denomination COSMACOL ESI
Batch 28L6
Production date November 1996
Identification sample n.: 19558
Receiving n. R05068.97
Receiving date November 13, 1997
Test animals
- Species:
- rat
- Strain:
- CD-1
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Species Rats
Strain CD
N. 10
Weight 225-231 g
Sex Males and Females
Supplier Charles River - Calco (CO)
EXPERIMENTAL DESIGN
10 white rats were used (5 males, 5 females).
Caging
The animals were caged in groups of 5 of the same gender m transparent polycarbonate cages (dimensions mm 425x266xl 80h).
The housing room was mantained under the following conditions:
Temperature: 22°c ±2°C
R.H.: hair was changed at least 25 times per hour and maintained at a pressure higher than the outside atmosphere
Artificial lighting: 12 h/day
Cleaning and disinfection
The cages and the housing room were cleaned and disinfected before the animals were accomodated, then cleaning and disinfection were performed periodically
Feeding
Animals were fed with standard pellet complete diet supplied by the authorized breeder Rieper.
Watering
Filtered tap water from local network was supplied ad libitum.
Animal identification
Each animal was identified with an indelible colouring in different parts of the body.
No sign 1
Head 2
Back 3
Tail 4
Head +tail 5
Cages were labelled.
Quarantine
Before being used in this study, the animals were kept in quarantine for one week. During this period they were observed daily.
At the end of the quarantine week the animals were carefully examined in order to evaluate their suitability for the study.
Animal selection
The animals used for this study were selected randomly from those suitable, available at that time.
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- Skin preparation
24 hours before the test the fur was removed from an area approximately 20 cm2 wide by clipping and shaving the dorsal and flank zones of the animals.
Administration
Square gauze pads 2.5 cm x 2.5 cm fixed to adhesive tape (Hansamed strips) were used. 2000 mg/kg of the assay sample were placed under the pad, which was kept in place by means of thin bands of adhesive hypoallergenic tape (Blenderm 3M).
The entire trunk of the animal was then wrapped with rubberized cloth (Acrylastic Beyersdorf AG Hamburg).
Removal ofthe patches
The patches were removed 24 hours after the application.
The exceeding paste was then washed away from skin using a pad soaked in distilled water. - Duration of exposure:
- 24 h
- Doses:
- 1
- No. of animals per sex per dose:
- 5 male
5 femal - Control animals:
- not required
- Details on study design:
- OBSERVATIONS
The general welfare of the animals was observed daily for 14 days. All observation were recorded daily in a form dated and signed.
In the course of the study the following was observed:
Mortality
The animals were observed every morning of the working week.
Clinical symptoms
Any clinical symptoms including variations of somatomotor activity were recorded daily for each animal.
Clinical observations included:
evaluation of organic bodys functions; evaluation of tegumentary apparatus; evaluation of mucosae conditions;
evaluation of somatomotor activity and sensorium conditions.
Bodyweight
Animals were weighed before the experiment, after 7 days and then at the end of the study.
Necropsy
At the end of the observation period rats were sacrificed and a necroptic survey was performed.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- No cases of mortality were observed during the study.
- Clinical signs:
- other: During the study in all treated animals no abnormalities were observed (see appendix)
- Gross pathology:
- At the autopsy in all treated animals no abnormalities was observed.
Applicant's summary and conclusion
- Conclusions:
- The DL50 is superior to 2000 mg/kg.
- Executive summary:
This study was performed to obtain information about the toxicity effect of teh test substance in accordance to EEC 92/69. The DL50 is superior to 2000 mg/kg.
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