Registration Dossier

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
Reference
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:
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 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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
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:
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.

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

 

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.

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.