2,3,4-trihydroxybenzophenone

Eye irritation

Administrative data

Endpoint:

eye 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:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1983

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

adopted 02 Oct 2012

Deviations:

yes

Remarks:

(analgesics and anesthetics were not used before instillation of the test substance, no individual scores were given, observation period terminated after 7 days instead of 21 days, no information on the purity of the test substance, non-GLP)

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 / tissue source

Species:

rabbit

Details on test animals or tissues 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

Vehicle:

unchanged (no vehicle)

Controls:

yes

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.1 g

Duration of treatment / exposure:

single application without washing, washing of the eyes after 30 s and 5 min (3 rabbits/group each)

Observation period (in vivo):

Reading time points: 24, 48, 72 and 96 h and 7 days

Number of animals or in vitro replicates:

3 animals per exposure group

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing: In two groups, the treated eye was washed 30 s and 5 min after instillation, respectively.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

of all 3 animals

Time point:

24/48/72 h

Remarks on result:

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

Results 2

Irritation parameter:

iris score

Basis:

mean

Remarks:

of all 3 animals

Time point:

24/48/72 h

Remarks on result:

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

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

of all 3 animals

Time point:

24/48/72 h

Remarks on result:

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

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

of all 3 animals

Time point:

24/48/72 h

Remarks on result:

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

Irritant / corrosive response data:

Corneal and iridic lesions were observed in all exposure groups beginning at 24 or 48 h after treatment. All rabbits exhibited conjunctival reactions of redness, swelling, and/or discharge. The ocular lesions were present during the first 96 h and in some cases persisted throughout the 1-week study period.
In the animals whose eyes were exposed to the test substance as single application without washing the test substance adhered to the inside of the eyelids during the initial reading time point of 24 h in 3/3 rabbits, persisting as dark material inside the eye lid in 2/3 rabbits. Slight pannus formation was also noted by the end of the study indicating possible permanent damage to the corneas in 3/3 animals in this exposure group.
In the animals whose eyes were exposed to the test substance for 30 s a darkened area was noted in 1/3 rabbits on Day 7. Slight conjunctival redness was also observed in 1/3 animals by the end of the 1-week study in this exposure group.
On day 7 2/3 rabbits of the 5 min wash group had clear eyes and 1 rabbit of the 30 s wash group had normals eyes besides slight conjunctival redness. All 3 rabbits of the no wash group had slight pannus formation.

Other effects:

1 rabbit of the 30 s wash group died on Day 7. Expect for diarrhea, which was present at the beginning of the study, no gross abnormalities were found. Thus, the death is considered unrelated to treatment.

Applicant's summary and conclusion

Interpretation of results:

Category 1 (irreversible effects on the eye) based on GHS criteria

Conclusions:

Based on the observations up to day 7 after treatment, the test item is considered to cause irreversible damage to the cornea and thus, cause serious eye damage.

Executive summary:

A study was conducted to evaluate the potential to cause eye irritation. 9 male rabbits were treated with a single application of 0.1 g undiluted test item in one eye each. Animals were divided into groups of 3 for different washing procedures. The eyes of one group were not washed and the eyes of the other groups were washed after 30 s or 5 min. Eyes were graded for ocular lesions after 24, 48, 72 and 96 h and 7 days. The test was terminated after 7 days. The grading system according to Draize was used. Corneal and iridic lesions were observed in all exposure groups beginning at 24 or 48 h after treatment. All rabbits exhibited conjunctival reactions of redness, swelling, and/or discharge. The ocular lesions were present during the first 96 h and in some cases persisted throughout the 1-week study period. In the animals whose eyes were exposed to the test substance as single application without washing the test substance adhered to the inside of the eyelids during the initial reading time point of 24 h in 3/3 rabbits, persisting as dark material inside the eye lid in 2/3 rabbits. Slight pannus formation was also noted by the end of the study indicating possible permanent damage to the corneas in 3/3 animals in this exposure group. In the animals whose eyes were exposed to the test substance for 30 s a darkened area was noted in 1/3 rabbits on Day 7. Slight conjunctival redness was also observed in 1/3 animals by the end of the 1-week study in this exposure group. On day 7 2/3 rabbits of the 5 min wash group had clear eyes and 1 rabbit of the 30 s wash group had normal eyes besides slight conjunctival redness. All 3 rabbits of the no wash group had slight pannus formation. 1 rabbit of the 30 s wash group died on Day 7. Expect for diarrhea, which was present at the beginning of the study, no gross abnormalities were found. Therefore, the death is considered unrelated to treatment. Based on the observations up to day 7 after treatment, the test item is considered to cause irreversible damage to the cornea and thus, cause serious eye damage.