Methyl 2,4-dihydroxy-3,6-dimethylbenzoate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

20 February, 1980 - 29 February, 1980

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Remarks:

Study is not conducted under GLP

Justification for type of information:

The information is from 1980. At the time no in vitro test methods were available.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1980

Report date:

1980

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

1981

GLP compliance:

no

Test material

Test material information

1

Reference substance name:

Methyl 2,4-dihydroxy-3,6-dimethylbenzoate

EC Number:

225-193-0

EC Name:

Methyl 2,4-dihydroxy-3,6-dimethylbenzoate

Cas Number:

4707-47-5

Molecular formula:

C10H12O4

IUPAC Name:

methyl 2,4-dihydroxy-3,6-dimethylbenzoate

Test material form:

other: solid

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: No data
- Age at study initiation: Yound adults
- Weight at study initiation: 2.0 to 3.5 kg
- Housing: Singly housed
- Diet: Daily 100g of Purina Rabbit Chow supplemented by whole oats.
- Water: Free access to water
- Acclimation period: No data.

ENVIRONMENTAL CONDITIONS
No data.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 100mg

Duration of treatment / exposure:

Single instillation.

Observation period (in vivo):

24, 48 and 72 hours and 4, 7 and 10 days

Number of animals or in vitro replicates:

6

Details on study design:

TREATMENT:
On the day of dosing, the lower lid was everted from the eyeball of the right eye to form a cup into which the test substance was placed. The eyelid was then gently held together for one second.

REMOVAL OF TEST SUBSTANCE
Eyes were not washed.

SCORING SYSTEM:
The ocular reaction of both eyes were scored according to the Method of Draize (see table) 24, 48 and 72 hours and 4 and 7 days after administration.
Scoring table:
0.0 - 0.5: non-irritating
0.6 - 10.0: practically non-irritating
10.1 - 25.0: mildly irritating
25.1 - 50.0: moderately irritating
50.1 - 110.0: extremely irritating

TOOL USED TO ASSESS SCORE:
At 24 hours and 7 days, both eyes of each animal were examined with fluorescein stain under an ultra violet light. Any persistent changes observed on Day 7 were re-evaluated on Day 10 using a hand held ophthalmoscope and the fluorescein method described previously.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

animal #1, #2, #3, #4, #5 and #6

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

iris score

Basis:

mean

Remarks:

animal #1, #2, #3, #4, #5 and #6

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 3

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

mean

Remarks:

animal #2 and #3

Time point:

24/48/72 h

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 48 hours

Results 4

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

mean

Remarks:

animal #1, #4, #5 and #6

Time point:

24/48/72 h

Score:

0

Max. score:

3

Results 5

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

animal #1, #2, #3, #4, #5 and #6

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

The dosed eyes of two rabbits had slight reddening of the conjuctivae observed at 24 hours only. The other four rabbits had normal eyes. At 48 hours and subsequently all eyes were normal. There was no fluorescein retention at any time period.
No animal had a positive score on day 7 and, in accordance with the protocol, none were retained for examination on day 10.

Applicant's summary and conclusion

Interpretation of results:

other: not classified

Remarks:

According to Regulation (EC) No 1272/2008 and its amendments.

Conclusions:

In an eye irritation study with 6 rabbits, performed equivalent to OECD 405 guideline, two rabbits had slight reddening of the conjuctivae observed at 24 hours only. The other four rabbits had normal eyes. All signs of irritation were reversible within 48 hours.

Executive summary:

The substance was tested in an eye irritation test in 6 rabbits equivalent to OECD TG 405 test guideline. The substance caused slight reddening of the conjuctivae in two animals at 24 hours only. The other four rabbits had normal eyes. At 48 hours and subsequently all eyes were normal. There was no fluorescein retention at any time period. Based on the results, the substance does not need to be classified for eye irritation according to EU CLP (EC No. 1272/2008 and its amendments).