4-tert-butylpyrocatechol

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 16 February 1987 to 27 May 1987

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The study was conducted according to a recognised guideline and under GLP conditions. However, the purity of the test substance is not specified.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1987

Report date:

1987

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

4-tert-butylpyrocatechol

EC Number:

202-653-9

EC Name:

4-tert-butylpyrocatechol

Cas Number:

98-29-3

Molecular formula:

C10H14O2

IUPAC Name:

4-tert-butylbenzene-1,2-diol

Test animals / tissue source

Species:

rabbit

Strain:

other: Hybrid Albino New-Zealand

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Strain: Hybrid Albino New-Zealand
- Sex: males
- Sources: *Charles River: Saint Aubin Les Elbeuf - 76410 Cléon - France
*E.G.A.V: Saint Mars d'Egrenne - 61350 Passais La Conception - France
*E.S.D: Roman - 01400 Châtillon sur Chalaronne - France
- Age at study initiation: no data
- Weight at study initiation: 2.5 +/- 0.2 kg
- Housing: individual housing, in polystyrene cages, of internal dimensions 560x355x315 mm, with a perforated floor
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: one week

ENVIRONMENTAL CONDITIONS
- Temperature: 20 +/- 3°C
- Humidity: 30 to 70%
- Air changes: no data
- Photoperiod: 12 hrs dark / 12 hours light

Test system

Vehicle:

other: no

Controls:

yes

Amount / concentration applied:

Amount applied: 0.1 ml

Observation period (in vivo):

21 days

Number of animals or in vitro replicates:

6

Details on study design:

REMOVAL OF TEST SUBSTANCE
no washing

SCORING SYSTEM: based on changes in cornea, iris, conjunctivae and chemosis, according to guideline OECD 405

TOOL USED TO ASSESS SCORE: Heine's ophthalmoscope / fluorescein

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

3.51

Max. score:

4

Reversibility:

not reversible

Remarks on result:

other: see table of results

Results 2

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

3.3

Max. score:

4

Reversibility:

not reversible

Results 3

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

3.3

Max. score:

4

Reversibility:

not reversible

Results 4

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

3.6

Max. score:

4

Reversibility:

not reversible

Results 5

Irritation parameter:

chemosis score

Basis:

animal #4

Time point:

24/48/72 h

Score:

4

Max. score:

4

Reversibility:

not reversible

Results 6

Irritation parameter:

chemosis score

Basis:

animal #5

Time point:

24/48/72 h

Score:

3.6

Max. score:

4

Reversibility:

not reversible

Results 7

Irritation parameter:

chemosis score

Basis:

animal #6

Time point:

24/48/72 h

Score:

3.3

Max. score:

4

Reversibility:

not reversible

Results 8

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

1.6

Max. score:

3

Reversibility:

not reversible

Remarks on result:

other: see table of results

Results 9

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1.6

Max. score:

3

Reversibility:

not reversible

Results 10

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1.3

Max. score:

4

Reversibility:

not reversible

Results 11

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

2

Max. score:

3

Reversibility:

not reversible

Results 12

Irritation parameter:

conjunctivae score

Basis:

animal #4

Time point:

24/48/72 h

Score:

2

Max. score:

3

Reversibility:

not reversible

Results 13

Irritation parameter:

conjunctivae score

Basis:

animal #5

Time point:

24/48/72 h

Score:

1.6

Max. score:

3

Reversibility:

not reversible

Results 14

Irritation parameter:

conjunctivae score

Basis:

animal #6

Time point:

24/48/72 h

Score:

1.3

Max. score:

3

Reversibility:

not reversible

Results 15

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

2

Max. score:

2

Reversibility:

not reversible

Remarks on result:

other: see table of results

Results 16

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

2

Max. score:

2

Reversibility:

not reversible

Results 17

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

2

Max. score:

2

Reversibility:

not reversible

Results 18

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

2

Max. score:

2

Reversibility:

not reversible

Results 19

Irritation parameter:

iris score

Basis:

animal #4

Time point:

24/48/72 h

Score:

2

Max. score:

2

Reversibility:

not reversible

Results 20

Irritation parameter:

iris score

Basis:

animal #5

Time point:

24/48/72 h

Score:

2

Max. score:

2

Reversibility:

not reversible

Results 21

Irritation parameter:

iris score

Basis:

animal #6

Time point:

24/48/72 h

Score:

2

Max. score:

2

Reversibility:

not reversible

Results 22

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

4

Max. score:

4

Reversibility:

not reversible

Remarks on result:

other: see table of results

Results 23

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

4

Max. score:

4

Reversibility:

not reversible

Results 24

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

4

Max. score:

4

Reversibility:

not reversible

Results 25

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

4

Max. score:

4

Reversibility:

not reversible

Results 26

Irritation parameter:

cornea opacity score

Basis:

animal #4

Time point:

24/48/72 h

Score:

4

Max. score:

4

Reversibility:

not reversible

Results 27

Irritation parameter:

cornea opacity score

Basis:

animal #5

Time point:

24/48/72 h

Score:

4

Max. score:

4

Reversibility:

not reversible

Results 28

Irritation parameter:

cornea opacity score

Basis:

animal #6

Time point:

24/48/72 h

Score:

4

Max. score:

4

Reversibility:

not reversible

Any other information on results incl. tables

Irritant/corrosive response data for each animal at each observation time

Score at time point / Reversibility	Cornea	Iris	Conjunctivae	Chemosis
	Max. score: 4	Max. score: 2	Max. score: 3	Max. score: 4
60 min	4/4/4/4/4/4	2/2/2/2/2/2	1/1/1/1/1/1	3/4/3/3/4/3
24 h	4/4/4/4/4/4	2/2/2/2/2/2	1/1/2/2/2/1	3/3/3/4/4/3
48 h	4/4/4/4/4/4	2/2/2/2/2/2	2/1/2/2/1/1	3/3/4/4/3/3
72 h	4/4/4/4/4/4	2/2/a/2/2/2	2/2/2/2/2/2	4/4/4/4/4/4
Average 24h, 48h, 72h	4/4/4/4/4/4	2/2/2/2/2/2	1.6/1.3/2/2/1.6/1.3	3.3/3.3/3.6/4/3.6/3.3
Reversibility*)	n.	n.	n.	n.
Average time (unit) for reversion	> 21 days	> 21 days	> 21 days	> 21 days

 

*) Reversibility: c. = completely reversible;n.c.= not completely reversible; n. = not reversible

a: the degree and the surface of the corneal opacification returned the impossible interpretation.

NB: a total necrosis of the eye was observed in 2 out of the 6 rabbits examined on day 14, on day 21, a necrosis area located on a quarter of the corneal surface was noted in the 3 surviving rabbits and the absence of direct photomotor reflex was still noted in 2 of them (the 2 rabbits showing a necrosis on day 14 were sacrified after the reading and another animal was found dead on day 20).

Applicant's summary and conclusion

Interpretation of results:

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

Conclusions:

4-tert-butylpyrocatechol 85% in water is classified as:
- Category 1 for irreversible effects on the eye according to UN/EU GHS classification

Executive summary:

In an eye irritation study (Hazleton, 1987), 0.1 mL 4 -tert-butylpyrocatechol 85% in water was instilled into the conjunctival sac of the right eye of hybrid Albino New-Zealand White rabbits (6 males) (no rinsing). Animals were then observed for 21 days. Ocular irritation was scored by the method of directive OECD 405.

After 1 hour of exposure, severe corneal opacity and iris lesions, moderate (4/6 rabbits) or severe (2/6 rabbits) chemosis and slight conjunctival redness were observed in all treated animals. These ocular irritation signs were not reversible after 21 days. In this study, 4 -tert-butylpyrocatechol 85% in water was highly irritating to the eye or causing irreversible effects on the eye based on the observed ocular reactions.