Reaction mass of 2-(2-thienyl)ethyl benzenesulphonate and toluene

Eye irritation

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other: GLP compliant, guideline study available as unpublished report, no restrictions, fully adequate for assessment.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

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Toluene

EC Number:

203-625-9

EC Name:

Toluene

Cas Number:

108-88-3

Molecular formula:

C7H8

IUPAC Name:

toluene

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 males and 2 females)

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

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24, 48 and 72h

Score:

0

Max. score:

4

Remarks on result:

other: no corneal effects

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24, 48 and 72h

Score:

0

Max. score:

2

Remarks on result:

other: mild iritis in 3 animals at 1 hour only

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 24, 48 and 72 hours

Score:

1.47

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

Results 4

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:

In conclusion, toluene was found to cause slight eye irritation. Ocular lesions (redness, chemosis) occurred within 72 hours after exposure and persisted for at least 24 hours. However, the mean score (24 hours 48 hours and 72 hours together) for redness of the conjunctivae and chemosis did
not exceed values of 2.5 and 2, respectively, which are the limits for classification with R36 (Irritating to eyes). Therefore, no classification for eye irritation was proposed.