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Toxicological information

Eye irritation

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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:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

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

Resultsopen allclose all
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
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
3.3
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
3.3
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
3.6
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
chemosis score
Basis:
animal #5
Time point:
24/48/72 h
Score:
3.6
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
chemosis score
Basis:
animal #6
Time point:
24/48/72 h
Score:
3.3
Max. score:
4
Reversibility:
not reversible
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
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1.6
Max. score:
3
Reversibility:
not reversible
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.3
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
not reversible
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
not reversible
Irritation parameter:
conjunctivae score
Basis:
animal #5
Time point:
24/48/72 h
Score:
1.6
Max. score:
3
Reversibility:
not reversible
Irritation parameter:
conjunctivae score
Basis:
animal #6
Time point:
24/48/72 h
Score:
1.3
Max. score:
3
Reversibility:
not reversible
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
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
not reversible
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
not reversible
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
not reversible
Irritation parameter:
iris score
Basis:
animal #4
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
not reversible
Irritation parameter:
iris score
Basis:
animal #5
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
not reversible
Irritation parameter:
iris score
Basis:
animal #6
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
not reversible
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
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
cornea opacity score
Basis:
animal #4
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
cornea opacity score
Basis:
animal #5
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not reversible
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.