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Diss Factsheets
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EC number: 205-031-5 | CAS number: 131-57-7
- 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
![](https://poisoncentres.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Endpoint summary
Administrative data
Description of key information
LD50 (oral rat) 12800 mg/kg bw
LD50 (dermal rabbit) > 16000 mg/kg bw
LD50 (intraperitonal mice) > 1600 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:
- June-July 1969
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: meets basic scientific principles, well documented information
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: commercial breeder (SPF)
- Weight at study initiation: 112.5 (104-121) g
- Fasting period before study: no
- Housing: single in MACROLON cages Type III
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum - Route of administration:
- oral: gavage
- Vehicle:
- other: aqueous suspension in 0.5 % carboxymethylcellulose
- Details on oral exposure:
- Given orally by way of an esophageal tube, in the form of a 16 - 32% aqueous suspension in 0.5% carboxymethyl cellulose.
- Doses:
- 1600, 3200, 6400, 12800 mg/kg
- No. of animals per sex per dose:
- ten (5 males, 5 females)
Total number of animals: forty (20 males, 20 females) - Control animals:
- not specified
- Details on study design:
- 40 rats (20 females, 20 males) were orally exposed at dose levels of 1600, 3200, 6400, 12800 mg/kg. Observations were recorded after 1, 7, 14 days observation period.
- Statistics:
- standard statistical methods
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 12 800 mg/kg bw
- Based on:
- test mat.
- Mortality:
- All the animals survived the 14-day observation period.
- Clinical signs:
- other: Most of the test animals exhibited sluggishness and/or slept for up to one hour following the application of the substance .Thereafter, no further changes were noted in the general condition and behavior of the animals.
- Gross pathology:
- One animal presented atelectasis of one of the lung lobes. All the other animals were unremarkable.
- Other findings:
- no data
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- In conclusion, LD50 after 1, 7 and 14 days of observation was in excess of 12,800 mg/kg in rats by orally.
- Executive summary:
Total 40 Wistar rats were exposed test article by orally at dose levels of 1600, 3200, 6400, 12800 mg/kg to assess the potential of acute toxicity. All the animals survived the 14-day observation period. There were no abnormal observations in the body weight during the test. Most of the test animals exhibited sluggishness and/or slept for up to one hour following the application of the substance .And no further changes were noted in the general condition and behavior of the animals.One animal presented atelectasis of one of the lung lobes. All the other animals were unremarkable.
Based on the results, it can be concluded that LD50 of test article was greater than 12800 mg/kg after 1, 7 and 14 days of observation.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 12 800 mg/kg bw
- Quality of whole database:
- The key study showing an LD50 (oral, rat) of 12800 mg/kg bw is perfectly in line with a supportive study documenting a LD50 (oral, rat) of 11600 mg/kg bw.
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:
- 1953
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study was performed prior to OECD guideline availability and GLP but follows basic scientific principles later adopted by OECD.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rabbit
- Strain:
- other: Albino
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- Animals were housed individually during study and observation period.
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- Application to shaved abdominal skin surface of white albino rabbits
- Duration of exposure:
- 18-22 hours, followed by a five day observation period
- Doses:
- 2, 4, 8 and 16 g/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- not required
- Statistics:
- no statistics was applied
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 16 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- One death at the 2 g/kg bw level occured and was probably associated with an intercurrent infection and not due to dermal application of the test material. Other than that no mortality occured.
- Clinical signs:
- other: Only mild skin irritation of short duration developed in 2 animals during the first 2 days of the study and only in animals of the lowest dose level.
- Gross pathology:
- Following necropsy and autopsy no significant gross findings were noted.
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- LD 50 (dermal, rabbit): > 16000 mg/kg bw
- Executive summary:
In this study for dermal acute toxicity performed with male albino rabbits, no treatment related mortality was observed up to a dose of 16 g/kg bw. Thus the LD50 was set to be greater than 16 g/kg bw.
Only mild skin irritations were noted and only in 2 animals of the low dose group (2 g/kg bw). Also, one animal from this dose group died at day 4 of the observation period. Both observations, mild skin irritation and mortality of one test animal were obviously not treatment related as these occured at the low dose group tested and no skin irritation nor mortality was observed at the higher dose groups.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 16 000 mg/kg bw
Additional information
The substance oxybenzone was investigated for acute toxicity following oral, dermal and intraperitonal application and was found to be practically non-toxic, despite being tested at rather high doses. Thus, oxybenzone is not subject to classification for acute toxicity according to CLP and/or DSD. Data on inhalation toxicity are not available and not required given the low vapour pressure and typical application in oil based skin creams of this product in use.
Justification for selection of acute toxicity – oral endpoint
reliable study on acute oral toxicity
Justification for selection of acute toxicity – dermal endpoint
Only dermal study available
Justification for classification or non-classification
Based on acute oral toxicity data (LD50 rat of 12800 mg/kg) and dermal toxicity data (LD 50 rabbit > 16000 mg/kg) the substance is not subject for classification for acute oral and/or dermal toxicity. No systemic effects were noted in any of the acute studies and hence oxybenzone is also not subject to classification as STOT single exposure. Data for inhalation exposure are lacking but not required and aspiration hazard classification is not required as the substance is not a hydrocarbon. Thus, oxybenzone is not subject to classification and labelling for acute toxicity according to CLP (Regulation EC No 1272/2008) or DSD (Directive 67/548/EEC).
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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