2-methylhydroquinone

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

1990

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Guideline study without GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

2,3,5-trimethylhydroquinone

EC Number:

211-838-3

EC Name:

2,3,5-trimethylhydroquinone

Cas Number:

700-13-0

IUPAC Name:

2,3,5-trimethylbenzene-1,4-diol

Details on test material:

- Name of test material (as cited in study report): 2,3,6-trimethylhydroquinone
- Batch: Feb. 20, 1990

Test animals / tissue source

Species:

rabbit

Strain:

Vienna White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: GAUKLER; D-6050 OFFENBACH/MAIN, Germany
- Weight at study initiation: mean 2.86 kg (male), 2.61 kg (female)
- Housing: stainless stell cages with wire mesh floor (area 40 cm x 51 cm)
- Diet (e.g. ad libitum): 4 MM; FIRMA KLINGENTALMUEHLE AG, CH-4303 KAISERAUGST, SWITZERLAND (ABOUT 130 G PER ANIMAL PER DAY)
- Water (e.g. ad libitum): ABOUT 250 ML TAP WATER PER ANIMAL PER DAY
- Acclimation period: at least 8 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated other eye of same animal

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml (ca. 12 mg)

Duration of treatment / exposure:

single application without washing

Observation period (in vivo):

21 d

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no

SCORING SYSTEM:
Cornea Opacity-degree of density (area most dense taken for reading)
0 = No opacity
1 = Scattered or diffuse area, details of iris clearly visible
2 = Easily discernible translucent areas, details of iris slightly obscured
3 = Opalescent areas, no details of iris visible, size of pupil barely discernible
4 = Opaque, iris invisible

Area of cornea involved
1 = One quarter (or less) but not zero
2 = Greater than one quarter, but less than half
3 = Greater than half, but less than three quarters
4 = Greater than three quarters, up to whole area

Iris
0 = Normal
1 = Folds above normal, congestion, swelling, circumcorneal injection (any or all of these or combination af any thereof) iris still reacting to light (sluggish reactions is positive)
2 = No reaction to light, hemorrhage, gross destruction (any or all of these)

Conjunctivae
Redness (refers to palpebral and bulbar conjunctivae excluding cornea and iris)
0 = Vessels normal
1 = Vessels definitely injected above normal
2 = More diffuse, deeper crimson red, individual vessels not easily discernible
3 = Diffuse beefy red

Chemosis
0 = No swelling
1 = Any swelling above normal (includes nictitatinq membrane)
2 = Obvious swelling with partial eversion of lids
3 = Swelling with lids about half closed
4 = Swelling with lids about half closed to completely closed

Discharge
0 = No discharge
1 = Any amount different from normal (does not include small amounts observed in inner canthus of normal animals
2 = Discharge with moistening of the lids and hairs just adjacent to lids
3 = Discharge with moistening of the lids and hairs, and considerable area around the eye

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24, 48, 72 h

Score:

1

Max. score:

4

Reversibility:

not fully reversible within: 21 d

Remarks on result:

other: Study discontinued after 8 days for 2/3 animals

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24, 48, 72 h

Score:

0

Max. score:

2

Reversibility:

other: not applicable

Remarks on result:

other: Study discontinued after 8 days for 2/3 animals

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 24, 48, 72 h

Score:

2.6

Max. score:

3

Reversibility:

not fully reversible within: 21 d

Remarks on result:

other: Study discontinued after 8 days for 2/3 animals

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24, 48, 72 h

Score:

3.2

Max. score:

4

Reversibility:

fully reversible within: 15 d

Remarks on result:

other: Study discontinued after 8 days for 2/3 animals

Any other information on results incl. tables

Animal 1: male, 2.94 kg

Animal 2: female, 2.61 kg

Animal 3: male, 2.77 kg

Table: Individual irritation findings (Draize scores) at the different reading times

Readings	Animal	cornea		Iris	conjunctiva			Symptons
		opacity	area		redness	swelling	discharge
1 h	1	0*	0*	0*	2*	4	2
	2	0	0	0	2	3	2
	3	0*	0*	0	2	4	3
24 h	1	1	4	0	3	3	2	pc,c
	2	1*	4*	0*	2	3	2	db,s
	3	1*	4*	0*	2	4	2	db,s
48 h	1	1	4	0	3	3	1	pc,s,re
	2	1*	4*	0*	2	3	3	db,s
	3	1*	4*	0*	2	4	3	db,s
72 h	1	1	4	0	3	2	1	pc,s,re
	2	1*	4*	0*	3	3	3	s
	3	1*	4*	0*	3	4	3	db,s
8 d	1	2	2	0	2	1	1	pc,s,re,mv,lh,lc
	2	2*	2*	0*	2	2	3	s,re,st
	3	2*	2*	0*	2	3	2	s,re.lh
15 d	1	1	1	0	2	0	0	pc,re,mv,lh,lc
	2							study discontinued
	3							study discontinued
21 d	1	1	1	0	1	0	0	pc,re,mv,lh,lc
	2
	3
mean 24 - 72 h	1	1.0		0.0	3.0	2.7
	2	1.0		0.0	2.3	3.0
	3	1.0		0.0	2.3	4.0
mean		1.0		0.0	2.6	3.2

*: score could not be read due to severe edema or suppuration
The study was discontinued for animals no 2 and 3 by study day 8 due to severe irritation.

Abbreviations:
db = discharge of blood
lh = loss of hair at the margins of the eyelids
lc = loss of corneal tissue
mv = marginal vascularization of the cornea
pc = pupil contracted
re = small retractions in the eyelids
s = suppuration
st = staphyloma

 

 

Applicant's summary and conclusion

Interpretation of results:

highly irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU