2,3,4-trihydroxybenzophenone

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1983

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1983

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

The study was conducted according to the Draize protocol (occlusive dressing, 24 h exposure period, abraded and intact test sites). Restrictions of the study: reading time point after 48 h missing, no individual scores, observation period terminated after 72 h

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

2,3,4-trihydroxybenzophenone

EC Number:

214-540-1

EC Name:

2,3,4-trihydroxybenzophenone

Cas Number:

1143-72-2

Molecular formula:

C13H10O4

IUPAC Name:

4-benzoylbenzene-1,2,3-triol

Test material form:

solid

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Elkhorn Rabbitry of Watsonville, CA, USA
- Weight at study initiation: 2 - 3 kg
- Housing: Animals were individually housed in hanging wire cages.
- Diet: Approximately 150 g of a commercial rabbit chow (Purina Rabbit Chow Complete Blend); fresh vegetables on occasion.
- Water: UV-purified drinking water, ad libitum.
- Acclimation period: 4 - 5 days

ENVIRONMENTAL CONDITIONS
- Air changes (per hr): air-conditioned rooms

Test system

Type of coverage:

occlusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.5 g

Duration of treatment / exposure:

24 h

Observation period:

Reading time points: 24 and 72 h

Number of animals:

6

Details on study design:

TEST SITE
- Area of exposure: Two unabraded and two abraded test sites were used on the dorsal area of the trunk of each rabbit. The back of each rabbit was clipped free of hair the day before treatment.
- Type of wrap if used: Each application site was covered with a gauze pad and the entire back was wrapped with a rubber dam.

OBSERVATION TIME POINTS: 24 and 72 h

SCORING SYSTEM: Draize scoring system

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

of all 6 animals

Time point:

24 h

Remarks on result:

other: no individual Draize scores were given in the study report

Results 2

Irritation parameter:

edema score

Basis:

mean

Remarks:

of all 6 animals

Time point:

24 h

Remarks on result:

other: no individual Draize scores were given in the study report

Results 3

Irritation parameter:

erythema score

Time point:

48 h

Remarks on result:

other: animals were not observed at the 48-h reading time point

Results 4

Irritation parameter:

edema score

Time point:

48 h

Remarks on result:

other: animals were not observed at the 48-h reading time point

Results 5

Irritation parameter:

erythema score

Basis:

mean

Remarks:

mean of all 6 animals

Time point:

72 h

Remarks on result:

other: no individual Draize scores were given in the study report

Results 6

Irritation parameter:

edema score

Basis:

mean

Remarks:

mean of all animals

Time point:

72 h

Remarks on result:

other: no individual Draize scores were given in the study report

Irritant / corrosive response data:

24 h after the application of the test substance barely perceptible to slight erythema at the treated sites in 4/6 animals were observed. 72 h after treatment a few scattered sites continued to have barely perceptible erythema. No edema was observed in any animal after 24 h and 72 h of observation. The primary irritation score was calculated to be 0.6.

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritant) based on GHS criteria

Remarks:

As worst case assessment the test substance is considered as irritant to the skin.

Conclusions:

The test item is considered a very mild irritant to skin.  

Executive summary:

A study was conducted to evaluate the potential to cause skin irritation. Six male rabbits were treated with undiluted test item. The back of each rabbit was clipped free of hair the day before treatment. Two unabraded and two abraded test sites were used on the dorsal area of the trunk of each rabbit. Each application site was covered with a gauze pad and the entire back was wrapped with a rubber dam. After 24 h the pads and wraps were removed and sites were scored for erythema and edema after 24 and 72 h according to Draize test grading system. 24 h after the application of the test substance barely perceptible to slight erythema at the treated sites in 4/6 animals were observed. 72 h after treatment a few scattered sites continued to have barely perceptible erythema. No edema was observed in any animal after 24 h and 72 h of observation. The primary irritation score was calculated to be 0.6. The test item is considered a very mild irritant to skin.