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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report date:
1995

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Version / remarks:
92/69/EEC
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
A mixture of: triphenylthiophosphate and tertiary butylated phenyl derivatives
EC Number:
421-820-9
EC Name:
A mixture of: triphenylthiophosphate and tertiary butylated phenyl derivatives
Cas Number:
192268-65-8
Molecular formula:
Unspecified
IUPAC Name:
A mixture of: triphenylthiophosphate and tertiary butylated phenyl derivatives
Details on test material:
- Appearance: yellowish liquid.
- Storage condition of test material: Room temperature in dark

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Froxfield (U.K.) Ltd., Petersfield, Hampshire, England.
- Age at study initiation: Approximately 12 to 14 weeks of age.
- Weight at study initiation: 2.7 to 3.2 kg.
- Housing: Individually in metal cages with perforated floors
- Diet: ad libitum; standard laboratory diet SDS Stanrab (P) Rabbit Diet (not analysed for nufrients, contaminants or micro-organisms)
- Water: ad libitum (analysed weekly for contaminants and micro-organisms)
- Acclimation period: All rabbits were acclimatised to the experimental environment.


ENVIRONMENTAL CONDITIONS
- Temperature (°C): ca. 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 contralateral eye remained untreated.
Amount / concentration applied:
Amount(s) applied:0.1 mL.
- Placed into the lower everted lid of one eye of each animal. The eyelids were then gently held together for one second before releasing.
Duration of treatment / exposure:
Single exposure (1 second).
Observation period (in vivo):
Examination of the eyes was made after 1 hour and 1, 2, 3 (equivalent to 24, 48 and 72 hours after instillation), 4 and 7 days after instillation.
Number of animals or in vitro replicates:
3 (One animal was treated in advance of the others, to ensure that if a severe response was produced, no further animals would be exposed)
Details on study design:
SCORING SYSTEM:
Ocular irritation was assessed using the prescribed numerical system:

Cornea
Opacity: Degree of density (area most dense taken for reading)
No ulceration or opacity 0
Scattered or diffuse areas of opacity (other than slight dulling of normal lustre), details of iris clearly visible 1
Easily discernible translucent areas, details of iris slightly obscured 2
Nacreous areas, no details of iris visible, size of pupil barely discernible 3
Opaque cornea, iris not discernible through the opacity 4

Iris
Normal 0
Markedly deepened rugae, congestion, swelling, moderate circumcorneal hyperaemia or injection, any of these or combination of any thereof, iris still reacting to light (sluggish reaction is positive) 1
No reaction to light, haemorrhage, gross destruction (any or all of these) 2

Conjunctivae
Redness (refers to the most severe reading of palpebral and bulbar conjunctivae, as compared to the control eye)
Blood vessels normal 0
Some blood vessels definitely hyperaemic (injected) 1
Diffuse, crimson colour, individual vessels not easily discernible 2
Diffuse beefy red 3

Chemosis (lids and/or nictating membranes)
No swelling 0
Any swelling above normal (includes nictating membranes) 1
Obvious swelling with partial eversion of lids 2
Swelling with lids about half-closed 3
Swelling with lids more than half-closed 4

TOOL USED TO ASSESS SCORE: Observation of the eyes was aided by the use of a handheld light.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: no effects
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: no effects
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: no effects
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
fully reversible within: 24 h
Remarks on result:
other: 1 hour after end of exposure: score = 2
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.333
Max. score:
3
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: 1 hour after end of exposure: score = 2
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
fully reversible within: 24 hours
Remarks on result:
other: 1 hour after end of exposure: score = 2
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24 h
Remarks on result:
other: 1 hour after end of exposure: score = 2
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24 h
Remarks on result:
other: 1 hour after end of exposure: score = 1
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 1 day
Remarks on result:
other: 1 hour after end of exposure: score = 1
Irritant / corrosive response data:
Reversibility of any observed effect: Changes fully reversible within 2 days.
At 1 h, grade 1 chemosis was observed in 2 animals and grade 2 chemosis was observed in 1 animal. Grade 2 redness was observed in all animals.
Conjunctiva (redness): Max. duration: 48 h; Max. value at end of observation period: 0 (related to all animals).
Conjunctiva (chemosis): Max. duration: 24 h; Max. value at end of observation period: 0 (related to all animals).
Other effects:
CLINICAL SIGNS: There were no signs of toxicity or ill health in any rabbit during the observation period.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met