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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:
other: GLP compliant, guideline study available as unpublished report, no restrictions, fully adequate for assessment.

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): toluene
- Physical state: colourless liquid
- Analytical purity: no information
- Expiration date: February 1996
- Storage condition of test material: room temperature

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: HRP, Inc, Denver, PA, USA
- Age at study initiation: males approx 12-13 weeks, females approx 11-12 weeks
- Weight at study initiation: 2.24-2.95 kg
- Housing: single housed in suspended stainless steel and wire mesh cages
- Diet: Agway certified diet RCA Rabbit (pellets) ad libitum
- Water: ad libitum via automatic system
- Acclimation period: at least 2 weeks

ENVIRONMENTAL CONDITIONS
- Temperature: approx 18-21°C
- Humidity: 40-60%
- Air changes (per hr): no information
- Photoperiod: 12 hrs dark /12 hrs light

IN-LIFE DATES: From: 4 October 1994 To: 11 October 1994

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.1 mL
Duration of treatment / exposure:
Single application
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
6 (4 male and 2 female)
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): NA - eyes were unwashed.

SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: 2% sodium fluorescein under UV light

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Remarks on result:
other: no corneal effects
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
2
Remarks on result:
other: mild iritis in 3 animals at 1 hour only
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
1.4
Max. score:
3
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: scores of 2 or 3 in all animals at 24 hours, 1 or 2 in all animals at 48 hours and 1 in 4 animals at 72 hours
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0.4
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: minimal chemosis in 5 animals at 24 hour and persisting until 48 hours in 2 animals
Irritant / corrosive response data:
There were no corneal effects and iridial effects were limited to 3 animals at the 1 hour observation only. At 1 hour conjunctival redness, chemosis, and discharge were observed in all animals. Redness was observed in all animals at 24 and 48 hours and in four animals at 72 hours. Chemosis was observed in five animals at 24 hours and two animals at 48 hours. Discharge was observed in four animals at 24 hours. In addition, dye retention of the nictitating membrane was observed in three animals at 24 hours and one at 48 hours. All conjunctival effects had recovered by day 7.


Other effects:
Clinical signs were not observed in any animal and all animals survived to study termination

Any other information on results incl. tables

Mean ocular irritation scores for each observation interval

 

1 hour

24 hour

48 hour

72 hour

7 day

Corneal opacity

0

0

0

0

0

Iritis

0.5

0

0

0

0

Conjunctival redness

3.00

2.17

1.50

0.67

0

Chemosis

3.33

0.83

0.33

0

0

 

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Toluene is not irritating to the rabbit eye.
Executive summary:

The eye irritation potential of toluene was evaluated following a single 0.1 mL instillation to the right eye of 6 New Zealand White rabbits. The treated eyes of all animals remained unwashed. Observations for signs of ocular irritation and toxicity were made at 1, 24, 48, and 72 hours post-instillation and on Day 7.

There were no corneal effects and iridial responses were limited to three animals at 1 hour. Toluene elicited conjunctival irritation in all animals from 1 hour which persisted until 72 hours in 4 animals but was fully recovered by day 7.

Toluene is slightly irritating to the rabbit eye but no classification is warranted under Dir 67/548/EEC or GHS.