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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

Endpoint summary
Administrative data
Description of key information
Oxybenzone is neither irritating to skin nor to eyes. Information on respiratory irritation is not available.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1990
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- adopted May 12, 1981
- Deviations:
- no
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Dr. K. Thomae GMBH, Chemisch-pharmazeutische Fabrik, Biberach/Riss, Germany
- Animal strain in detail: Chbb:NZW
- Age at study initiation: approx. 9-13 weeks old
- Weight at study initiation: 2210 to 2440 g
- Housing: individually
- Diet: standard rabbit pellet - Nafag No. 814, Gossau, Switzerland, ad libitum
- Water: fresh water, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12 / 12 - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: not required, untreated sites of the same animal served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 3 females
- Details on study design:
- TEST SITE
- Area of exposure: at least 36 cm² was shaved on both flanks of the animals approximately 24 hours before treatment. A gauze patch (approx. 12-16 cm²) bearing 0.5 g of the test item was applied to the right flank of each animal. A control gauze patch was applied to the other flank. Both patches were moistened before application with distilled water.
- Type of wrap if used: patches were loosely covered with an aluminum foil (approx. 36 cm²) and held in place for 4 hours by an adhesive tape (Isoplast, Isoplast AG, Brugg, Switzerland).
SCORING SYSTEM: Draize system
-Reading time point: 1, 24, 48, and 72 hours after removing the gauze patches
OTHER
- The animals were checked daily for systemic symptoms and mortality. Bodyweight was recorded at study initiation and on day 3 of the observation period. - Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- out of all 3 animals
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- out of all 3 animals
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritant / corrosive response data:
- No skin reactions were observed one hour after removal of the test patches as well as at reading time points 24 hours to 72 hours. Therefore, the observation period was ended after the 72 hours evaluation.
- Other effects:
- No other effects observed.
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Oxybenzone was shown not to be irritant to rabbit skin in this test.
- Executive summary:
No effects in any of the animals were observed in this test and as a aconsequence the observation period was terminated after 3 days. The substance oxybenzone is considered not to be irritant to rabbit skin.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1990
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- adopted May 12, 1981
- Deviations:
- no
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Dr. K. Thomae GMBH, Chemisch-pharmazeutische Fabrik, Biberach/Riss, Germany
- Animal strain in detail: Chbb:NZW
- Age at study initiation: approx. 9-13 weeks old
- Weight at study initiation: 2290 to 2490 g
- Housing: individually
- Diet: standard rabbit pellet - Nafag No. 814, Gossau, Switzerland, ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12 / 12 - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The right eye remained untreated and served as a control.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml (32 mg) was placed into the conjunctival sac of the left eye of each animal, after gently pulling away the lower lid from the eyeball. The lids were then held together for about one second in order to prevent loss of the test article. - Duration of treatment / exposure:
- single application
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 3 females
- Details on study design:
- SCORING SYSTEM: Draize system
- Scoring time: The ocular reactions were evaluated 1, 24, 48, and 72 hours after the instillation of the test item
TOOL USED TO ASSESS SCORE: slit lamp
OTHER:
- The animals were checked daily for systemic symptoms and mortality.
- Bodyweight was recorded at study initiation and on days 3 and 7 of the observation period. - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- out of all 3 animals
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- out of all 3 animals
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- out of all 3 animals
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritant / corrosive response data:
- Slight conjunctivae redness (grade 1) seen at reading time points 1 hour up to 72 hours in 2/3 animals was reversible within 7 days after application. The average score (24, 48 and 72 hours) for irritation was calculated to be 1.0 (for conjunctivae redness). Slight, reversible conjunctivae redness (grade 1) was noted in the third animal 1 hour to 48 hours after application, fully reversible within 72 hours. Chemosis (grade 1) was observed in 3/3 animals one hour after treatment, only.
- Other effects:
- No other findings were observed.
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Oxybenzone was found to be slightly irritating to rabbit eyes, fully reversible within 7 days, in this test but does not require classification according to CLP and/or DSD.
- Executive summary:
Slight conjunctivae redness (grade 1) observed at reading time points 1 hour up to 72 hours in 2/3 animals was reversible within 7 days after application. The average score (24, 48 and 72 hours) for irritation was calculated to be 1.0 (for conjunctivae redness). Slight, reversible conjunctivae redness(grade 1) was noted in the third animal 1 to 48 hours after application.Therefore, average score (24, 48 and 72 hours) for irritation was calculated to be 0.67 (for conjunctivae redness) for this animal. For corneal opacity, iris and chemosis the average score (24, 48 and 72 hours) for irritation was calculated to be 0.0.The eye irritation study is acceptable (reliability 1), and does satisfy the guideline requirements for an eye irritation test (OECD 405) in rabbits.
Under the experimental conditions chosen, the test substance was considered to be not irritating to the eye of rabbits.Therefore, the test item is not warranted to be classified according to the EU Directive 67/548/EC and according to the CLP Regulation 1272/2008.
Reference
Table 1. Results of eye irritation study.
Rabbit #
|
Time |
conjunctivae |
iris |
cornea |
|
redness |
chemosis |
||||
1
|
1 h |
1 |
1 |
0 |
0 |
24 h |
1 |
0 |
0 |
0 |
|
48 h |
1 |
0 |
0 |
0 |
|
72 h |
1 |
0 |
0 |
0 |
|
7 d |
0 |
0 |
0 |
0 |
|
average over 24, 48 and 72 h |
1.0 |
0.0 |
0.0 |
0.0 |
|
2
|
1 |
1 |
1 |
0 |
0 |
24 h |
1 |
0 |
0 |
0 |
|
48 h |
1 |
0 |
0 |
0 |
|
72 h |
1 |
0 |
0 |
0 |
|
7 d |
0 |
0 |
0 |
0 |
|
average over 24, 48 and 72 h |
0.0 |
0.0 |
0.0 |
0.0 |
|
3
|
1 |
1 |
1 |
0 |
0 |
24 h |
1 |
0 |
0 |
0 |
|
48 h |
1 |
0 |
0 |
0 |
|
72 h |
0 |
0 |
0 |
0 |
|
7 d |
0 |
0 |
0 |
0 |
|
average over 24, 48 and 72 h |
0.67 |
0.0 |
0.0 |
0.0 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin corrosion / irritation
Oxybenzone has been investigated in two studies for skin irritation; the key study was performed according to OECD 404 and showed no skin irritation. The supporting study performed in 1969 (prior to OECD test guidelines) supports this finding. Consequently, an in-vitro study is not required and the substance is considered not to be a skin irritant or corrosive.
Eye irritation
Oxybenzone has also been investigated in two studies for eye irritation; the key study was performed according to OECD 405 and showed only very slight, fully reversible eye irritation. The supporting study performed in 1969 (prior to OECD test guidelines) supports this finding. Consequently, an in-vitro study is not required and the substance is considered not to be an eye irritant.
Data on Respiratory information is not available.
Justification for selection of skin irritation / corrosion endpoint:
The key study appears more reliable and was conducted according to OECD guideline. The findings are well supported by the supporting study performed in 1969.
Justification for selection of eye irritation endpoint:
The key study appears more reliable and was conducted according to OECD guideline. The findings are well supported by the supporting study performed in 1969.
Justification for classification or non-classification
The substance was tested for skin and eye irritation / corrosion and found negative. Therefore, the substance does not require classification for skin corrosion / irritation respectively eye irritation according to CLP (Regulation EC No 1272/2008) or DSD (Directive 67/548/EEC). Data on respiratory information is lacking.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.

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