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EC number: 204-260-8 | CAS number: 118-56-9
- 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
LD50 (oral, rat): >5000 mg/kg
LD50 (dermal, rabbit): >5000 mg/kg
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:
- 1977
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: pre OECD and pre-GLP study with limited documentation but fulfilling basic scientific principles
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- no
- Test type:
- fixed dose procedure
- Limit test:
- yes
- Species:
- rat
- Strain:
- not specified
- Sex:
- not specified
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- Homosalate was administered orally at a single dose level of 5000 mg/kg bw.
- Doses:
- 5 g/kg bw as single dose
- No. of animals per sex per dose:
- 10 animals were used in this study
- Control animals:
- no
- Details on study design:
- The animals were observed for treatment-related effects and gross pathology was performed.
- Statistics:
- not required
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: only 1 out of ten animals was found dead during observation period
- Mortality:
- one animal was found dead during observation period (day 6)
- Clinical signs:
- other: Animal that died showed signs of diarrhea
- Gross pathology:
- Necropsy revealed 4/10 animals were normal; yellow areas in the intestines of 1/10 animals; mottled liver in 1/10 animals; dark lungs in 1/10 animals; dark areas in the lungs in 5/10 animals; dark spleen in 1/10 animals.
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- LD50 (oral, rat): > 5000 mg/kg bw
- Executive summary:
In this study 10 rats per dose were used (only one dose applied being 5000 mg/kg and therefore no further doses were applied). Animals were observed for mortality and/or systemic effects. Gross necropsy was performed on all animals.
One out of 10 rats died on day 6 of the observation period and thus the LD50 was found being > 5000 mg/kg. No further doses were consequently applied and the study may be considered as limit test accordingly.
Clinical sign observed were diarrhea. 4 out of 10 animals showed no effects upon necropsy. Effects seen in 6 animals were yellow areas in the intestines of 1/10 animals; mottled liver in 1/10 animals; dark lungs in 1/10 animals; dark areas in the lungs in 5/10 animals; dark spleen in 1/10 animals.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1977
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: pre OECD and pre-GLP study with limited documentation but fulfilling basic scientific principles
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rabbit
- Strain:
- not specified
- Sex:
- not specified
- Type of coverage:
- not specified
- Vehicle:
- unchanged (no vehicle)
- Doses:
- 5000 mg/kg bw applied
- No. of animals per sex per dose:
- 10 animals
- Control animals:
- no
- Statistics:
- not required
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- no deaths occured
- Clinical signs:
- other: No clinical signs were observed.
- Gross pathology:
- Necropsy revealed 6/10 animals were normal; brown anogenital exudate in 1/10 animals; red areas in the intestines in 1/10 animals; bloated intestines in 1/10 animals; dark liver in 2/10 animals; white nodules in the liver in 2/10 animals.
- Other findings:
- Skin redness slight in 4/10 and moderate in 6/10 animals
Skin edema slight in 7/10 and moderate in 3/10 animals - Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- LD50 (dermal., rabbit): > 5000 mg/kg bw
- Executive summary:
In this study 10 rabbits per dose were used (only one dose applied being 5000 mg/kg and therefore no further doses were applied). Animals were observed for mortality and/or systemic effects. Gross necropsy was performed on all animals.
All rabbits survived the study until end and thus the LD50 was found being > 5000 mg/kg. No further doses were consequently applied and the study may be considered as limit test accordingly.
No clinical sign observed. Necropsy revealed 6/10 animals were normal; brown anogenital exudate in 1/10 animals; red areas in the intestines in 1/10 animals; bloated intestines in 1/10 animals; dark liver in 2/10 animals; white nodules in the liver in 2/10 animals.
Slight skin redness was observed in 4 and moderate redness in 6 animals whereas in 7 animals slight edema were noted and moderate edemas in thee remainder.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Additional information
Homosalate has been investigated in an acute oral toxicity study and an acute dermal toxicity study by O.M. Moreno (MB Research Laboratories, Inc.) and found in both studies having an LD50 > 5000 mg/kg. Thus, no further doses were applied and the study is considered as limit dose study.
Whereas in the oral study using rats diarrhea was observed in one animal that died at day 6 of the observation period, in the dermal study no clinical signs were observed.
Necropsy observations were made in all animals and in the oral study 4 animals out of 10 showed no pathological abnormalities and in the dermal studies 6 out of 10 animals showed no abnormalities. Effects seen at necropsy were rather unspecific including discoloration of intestines, liver and lung tissue and spleen in oral study and discoloration of intestines and liver tissue in the dermal study.
Justification for selection of acute toxicity – oral endpoint
one study available
Justification for selection of acute toxicity – dermal endpoint
one study available
Justification for classification or non-classification
Based on results from an oral and a dermal acute study, both showing LD50 values > 5000 mg/kg, the substance is not classifiable for oral or dermal acute toxicity. No effects were noted requiring Specific Target Organ Toxicity on Single Exposure (STOT SE) and thus the substance is not classifiable according to CLP (Regulation EC No 1272/2008) or DSD (Directive 67/548/EEC) for oral or dermal acute toxicity. Data on inhalative toxicity are not available and not required.
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