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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:
1985
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study without detailed documentation.
Cross-reference
Reason / purpose for cross-reference:
reference to same study

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1985
Report date:
1985
Reference Type:
publication
Title:
Unnamed
Year:
1988

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
reliability scoring based on 2002 guideline.
Deviations:
yes
Remarks:
- Humidity, temperature, housing conditions not provided
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
4-tert-butylphenol
EC Number:
202-679-0
EC Name:
4-tert-butylphenol
Cas Number:
98-54-4
Molecular formula:
C10H14O
IUPAC Name:
4-tert-butylphenol
Details on test material:
- Name of test material (as cited in study report): para-tertiary butylphenol, UCAR Butylphenol 4T-Flake (para tert-Butyl Phenol), PTBP.
- Physical state: White flakes.
- Analytical purity: Not reported.
- Lot/batch No.: Charge No. 496500; BRRC Sample No. 48-186.
- Expiration date of the lot/batch: Not reported.
- Stability under test conditions: Not reported.
- Storage condition of test material: Not reported.

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Hazleton Research Animals, Denver, PA.
- Age at study initiation: Not reported.
- Weight at study initiation: 2 to 3 kg.
- Fasting period before study: Not reported.
- Housing: Not reported.
- Diet (e.g. ad libitum): Animals were maintained on appropriate commercial diet, ad libitum.
- Water (e.g. ad libitum): Animals were maintained on municipal water, ad libitum.
- Acclimation period: At least 5 days.


ENVIRONMENTAL CONDITIONS
- Temperature (°C): Not reported.
- Humidity (%): Not reported.
- Air changes (per hr): Not reported.
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
Primary ocular irritation of PTBP was assessed by placing 10 or 80 mg of dry, finely ground powder into the lower conjunctival sac of one eye of each of 3 male and 3 female rabbits per dose level.
Duration of treatment / exposure:
1 second / single exposure.
Observation period (in vivo):
21 days after dosing.
Number of animals or in vitro replicates:
3/sex/dose
Details on study design:
The lids were then held together for one second. The eyes were not rinsed after exposure to the chemical. The eyes were scored by the system listed in Attached File 1, which is based on the method of Draize et al., 1944, 1959. Examination of the eyes was performed prior to dosing and at 1, 4, and 24 hours and 2, 3, 7, 14, and 21 days after dosing. Corneas were also stained with 2% fluorescein at all intervals except at 1 and 4 hour post-dosing.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Remarks:
- opacity
Basis:
mean
Remarks:
- 80 mg
Time point:
other: 24 h
Score:
2.5
Max. score:
4
Reversibility:
not fully reversible within: 21 days
Remarks on result:
other: Refer to Attached File 3
Irritation parameter:
cornea opacity score
Remarks:
- opacity
Basis:
mean
Remarks:
- 80 mg
Time point:
other: 48 and 72 h
Score:
2.7
Max. score:
4
Reversibility:
not fully reversible within: 21 days
Remarks on result:
other: Refer to Attached File 3
Irritation parameter:
iris score
Basis:
mean
Remarks:
- 80 mg
Time point:
other: 1 and 4 h
Score:
1
Max. score:
2
Reversibility:
not fully reversible within: 4 h; Scoring not possible beyond 4 h because of conjunctival swelling or corneal opacity.
Remarks on result:
other: Refer to Attached File 3
Irritation parameter:
conjunctivae score
Remarks:
- redness
Basis:
mean
Remarks:
- 80 mg
Time point:
other: 24 h and 48 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 21 days
Remarks on result:
other: Refer to Attached File 3
Irritation parameter:
conjunctivae score
Remarks:
- redness
Basis:
mean
Remarks:
- 80 mg
Time point:
other: 72 h
Score:
2.2
Max. score:
3
Reversibility:
fully reversible within: 21 days
Remarks on result:
other: Refer to Attached File 3
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
- 80 mg
Time point:
other: 24 h
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 21 days
Remarks on result:
other: Refer to Attached File 3
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
- 80 mg
Time point:
other: 48 h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 21 days
Remarks on result:
other: Refer to Attached File 3
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
- 80 mg
Time point:
other: 72 h
Score:
3.8
Max. score:
4
Reversibility:
not fully reversible within: 21 days
Remarks on result:
other: Refer to Attached File 3
Irritation parameter:
cornea opacity score
Remarks:
- opacity
Basis:
mean
Remarks:
- 10 mg
Time point:
other: 24 and 72 h
Score:
1.8
Max. score:
4
Reversibility:
not fully reversible within: 21 days
Remarks on result:
other: Refer to Attached File 3
Irritation parameter:
cornea opacity score
Remarks:
- opacity
Basis:
mean
Remarks:
- 10 mg
Time point:
other: 48 h
Score:
1.7
Max. score:
4
Reversibility:
not fully reversible within: 21 days
Remarks on result:
other: Refer to Attached File 3
Irritation parameter:
iris score
Basis:
mean
Remarks:
- 10 mg
Time point:
other: 24 h
Score:
1
Max. score:
2
Reversibility:
not fully reversible within: 48 h; Scoring not possible beyond 4 h because of conjunctival swelling or corneal opacity.
Remarks on result:
other: Refer to Attached File 3
Irritation parameter:
iris score
Basis:
mean
Remarks:
- 10 mg
Time point:
other: 48 h
Score:
0.8
Max. score:
2
Reversibility:
not fully reversible within: 48 h; Scoring not possible beyond 4 h because of conjunctival swelling or corneal opacity.
Remarks on result:
other: Refer to Attached File 3
Irritation parameter:
conjunctivae score
Remarks:
- redness
Basis:
mean
Remarks:
- 10 mg
Time point:
other: 24 and 48 h
Score:
1
Max. score:
3
Reversibility:
not fully reversible within: 21 days
Remarks on result:
other: Refer to Attached File 3
Irritation parameter:
conjunctivae score
Remarks:
- redness
Basis:
mean
Remarks:
- 10 mg
Time point:
other: 72 h
Score:
1.2
Max. score:
3
Reversibility:
not fully reversible within: 21 days
Remarks on result:
other: Refer to Attached File 3
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
- 10 mg
Time point:
other: 24 h
Score:
2.2
Max. score:
4
Reversibility:
not fully reversible within: 21 days
Remarks on result:
other: Refer to Attached File 3
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
- 10 mg
Time point:
other: 48 h
Score:
1.5
Max. score:
4
Reversibility:
not fully reversible within: 21 days
Remarks on result:
other: Refer to Attached File 3
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
- 10 mg
Time point:
other: 72 h
Score:
1.3
Max. score:
4
Reversibility:
not fully reversible within: 21 days
Remarks on result:
other: Refer to Attached File 3
Irritant / corrosive response data:
The scores for the primary ocular irritation test at dosages of 80 and 10 mg of PTBP are presented in Attached File 2. Instillation of 80 mg PTBP produced severe corneal injury (with vascularization and surface bulges), iritis, and severe conjunctival irritation which persisted through the 21-day postexposure observation period. Similar effects were observed in the group dosed with 10 mg PTBP. Although the severity of the effects in this lower dosage group decreased with time, the signs of irritation and injury again persisted in most eyes for the 21-day post-exposure observation period.
Other effects:
Not applicable.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria