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EC number: 202-653-9 | CAS number: 98-29-3
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- Ecotoxicological Summary
- Aquatic toxicity
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- Short-term toxicity to fish
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- Toxicological Summary
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- Acute Toxicity
- Irritation / corrosion
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- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
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- Additional toxicological data

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:
- 1 987
- 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
- 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
Constituent 1
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.
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