Registration Dossier

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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report date:
1990

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
Remarks:
The study was conducted according to guideline in effect at time of study conduct.
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
4,4',4''-(ethan-1,1,1-triyl)triphenol
EC Number:
405-800-7
EC Name:
4,4',4''-(ethan-1,1,1-triyl)triphenol
Cas Number:
27955-94-8
Molecular formula:
C20H18O3
IUPAC Name:
4-[1,1-bis(4-hydroxyphenyl)ethyl]phenol
Details on test material:
-Purity: 99%

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Age at study initiation: 13 weeks
- Weight at study initiation: 3.0-3.2 kg
- Housing: metal cages with perforated floors
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: rabbits were acclimated; period of time not reported

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19
- Humidity (%): 30-70%
- Air changes (per hr): 19
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The untreated eye served as control.
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 90 mg (0.1 mL volume) per animal

Duration of treatment / exposure:
single instillation of test substance in the eye
Observation period (in vivo):
one hour and 1, 2, 3, 4, and 7 days after instillation
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): not reported
- Time after start of exposure: not reported

SCORING SYSTEM:
The standardized grading system for cornea (0-4), iris (0-2), and conjunctiva (redness, 0-3; chemosis, 0-4) used in testing guidelines of the OECD was used.

TOOL USED TO ASSESS SCORE: hand-held torch

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
Mild conjunctival inflammation was observed one hour after instillation in all three animals and in one animal the following day. Individual animal data can be found in Table 1 in the Remarks on results section.

Any other information on results incl. tables

Table 1: Individual Animal Ocular Effects

Time after Instillation

Rabbit Number

Cornea

Iritis

Conjunctiva

 

 

Opacity

 

Redness

Chemosis

1 Hour

1756

0

0

1

1

1842

0

0

1

1

1843

0

0

1

1

1 Day

1756

0

0

1

0

1842

0

0

0

0

1843

0

0

0

0

2 Days

1756

0

0

0

0

1842

0

0

0

0

1843

0

0

0

0

3 Days

1756

0

0

0

0

1842

0

0

0

0

1843

0

0

0

0

4 Days

1756

0

0

0

0

1842

0

0

0

0

1843

0

0

0

0

7 Days

1756

0

0

0

0

1842

0

0

0

0

1843

0

0

0

0

 

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Instillation of the test substance into the rabbit eye elicited transient mild conjunctival irritation only.
Executive summary:

The test substance was evaluated for acute eye irritation potential in 3 young adult New Zealand white rabbits. An aliquot of 90 mg of the test substance was administered to 1 eye of each animal. Washing the eyes was not reported. The untreated eye served as a control. The conjunctiva, iris, and cornea of each treated eye were evaluated and scored according to a numerical scale approximately 1, 24, 48, 72, and 96 hours, and 7 days following administration. No corneal damage or iridial inflammation was seen throughout the observation period. Mild conjunctival inflammation was observed one hour after instillation in all 3 animals and in one animal the following day. All reactions had resolved by 48 hours after instillation.