Dioxybenzone

pH

Administrative data

Endpoint:

pH

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2008

Reliability:

1 (reliable without restriction)

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Reference

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2008

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study under GLP conditions

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes (incl. QA statement)

Remarks:

2007-10-15

Specific details on test material used for the study:

Name: 2,2’ -Dihydroxy-4-methoxybenzophenone
Batch/Lot Number: 8010111
Description:Yellow powder
Expiry Date: 26 August 2008
Storage Conditions: Room Temperature in the dark

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan UK Limited, Bicester, Oxon, UK
- Age at study initiation: 12-20 weeks old
- Weight at study initiation: 2.0-3.5 kg
- Housing: individually housed in suspended cages; the animals were provided with environmental enrichment items
- Diet: free access, 2030 Teklad Global Rabbit diet supplied by Harlan Teklad)
- Water: free access
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23 °C
- Humidity (%): 30-70%
- Air changes (per hr): at least 15 changes per hour
- Photoperiod (hrs dark / hrs light): 12/12h

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

water

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.5g
VEHICLE
- Amount(s) applied: 0.5 ml

Duration of treatment / exposure:

4 h

Observation period:

72 h

Number of animals:

3

Details on study design:

TEST SITE
- Type of wrap: elasticated corset

REMOVAL OF TEST SUBSTANCE
- Washing: removed by gentle swabbing with cotton wool soaked in distilled water
- Time after start of exposure: 4h

OBSERVATION TIME POINTS
1h, 24h, 48h and 72h

SCORING SYSTEM:
- Method of calculation: Draize JH 1959

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Reversibility:

other: Not applicable

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

other: Not applicable

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

other: Not applicable

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Reversibility:

other: Not applicable

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

other: Not applicable

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

other: Not applicable

Irritant / corrosive response data:

No evidence of skin irritation was noted during the study.

Other effects:

All animals showed expected gain in bodyweight during the study.

Skin reaction	Observation time	Individual scores – rabbit number and sex			Total
		Animal 1 Male	Animal 2 Male	Animal 3 Male
Erythema/Eschar Formation	1 Hour 24 Hours 48 Hours 72 Hours	0 0 0 0	0 0 0 0	0 0 0 0	(0) 0 (0) 0
Oedema Formation	1 Hour 24 Hours 48 Hours 72 Hours	0 0 0 0	0 0 0 0	0 0 0 0	(0) 0 (0) 0
Sum of 24 and 72-hour readings: 0
Primary irritation index (S/6): 0/6 = 0.0
Classification: NON IRRITANT

Interpretation of results:

GHS criteria not met

Conclusions:

The test material produced a primary irritation index of 0.0 and was classified as Non-irritant to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.

Executive summary:

2,2 -Dihydroxy-4 -methoxybenzophenone was tested according to OECD Test guideline 404 and GLP criterias for its skin irritation potential.

For all three animals, irritation scores were of 0. The test substance is not irritating to the skin of rabbits.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2008

Report date:

2008

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

pH measurement performed before skin irritaiton assessment of the test substance.

GLP compliance:

yes (incl. QA statement)

Remarks:

2007-10-15

Test material

Test material information

Constituent 1

Reference substance name:

Dioxybenzone

EC Number:

205-026-8

EC Name:

Dioxybenzone

Cas Number:

131-53-3

Molecular formula:

C14H12O4

IUPAC Name:

2-(2-hydroxybenzoyl)-5-methoxyphenol

Test material form:

solid: particulate/powder

Specific details on test material used for the study:

Name: 2,2’ -Dihydroxy-4-methoxybenzophenone
Batch/Lot Number: 8010111
Description:Yellow powder
Expiry Date: 26 August 2008
Storage Conditions: Room Temperature in the dark

Reagents

Reagent:

water

Results and discussion

pH value

pH value:

8.1

Concentration:

10 other: % w/w

Any other information on results incl. tables

10 % w/w aqueous prepration of the test material: pH measured was 8.1 immediately and after 10 minutes.

Applicant's summary and conclusion

Conclusions:

The test item has a pH of 8.1 when prepared to a 10% w/w aqueous solution.

Executive summary:

2,2'-Dihydroxy-4 -methoxybenzophenone has a pH of 8.1 when prepared to a 10% w/w aqueous solution.