Sodium toluene-4-sulphonate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1989

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Sodium toluene-4-sulphonate

EC Number:

211-522-5

EC Name:

Sodium toluene-4-sulphonate

Cas Number:

657-84-1

Molecular formula:

C7H7O3S.Na

IUPAC Name:

4-methylbenzenesulfonic acid

Test animals / tissue source

Species:

rabbit

Strain:

other: Small White Russian

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Dr. Karl Thomae GmbH, Biberach, Germany
- Age at study initiation: not mentioned
- Weight at study initiation: 2.2 - 2.6 kg
- Housing: conventional, singly in stainless steel cages
- Diet (e.g. ad libitum): K4 complete feed for rabbits ad libitum, supplied by Ssniff Spezialfutter GembH, Soest, Germany
- Water (e.g. ad libitum): Drinking water ad libitum
- Acclimation period: 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 1
- Humidity (%): 60 ± 5
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 1989-10-10 To: 1989-10-31

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: the untreated eye

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g

Duration of treatment / exposure:

24 hours

Observation period (in vivo):

1, 24, 48 and 72 hours, and 6, 8, 10, 13, 17 and 21 days after application

Number of animals or in vitro replicates:

3 males

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with warm physiological saline
- Time after start of exposure: 24 hours

SCORING SYSTEM: according to guideline

TOOL USED TO ASSESS SCORE: ophthalmic lamp, fluorescein 72 hours after administration

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

not fully reversible within: 21 days (1 animal)

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

1

Max. score:

2

Reversibility:

not fully reversible within: 21 days (1 animal)

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

3

Max. score:

3

Reversibility:

not fully reversible within: 21 days (1 animal)

Results 4

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 21 days

Results 5

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

2.33

Max. score:

4

Reversibility:

not fully reversible within: 21 days

Results 6

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 21 days

Irritant / corrosive response data:

AVERAGE SCORE (24, 48 and 72 h)
- Cornea: 2.0
- Iris: 1.0
- Conjunctivae (Redness): 3.0
- Conjunctivae (Chemosis): 2.33

Other effects:

Dark red erythema, strong swelling and necrotic variations of mucosa and nictitating membrane, all animals. Opacity and hemorrhage on iris, up to 6 days on two animals; strong opacity and strong circumcorneal injection of iris on day 21 still on one animal.
The test item had a moderately irritating effect on the eyes.1 of 3 animals showed irreversible damages at cornea, iris and conjunctivae.

Any other information on results incl. tables

Table: Irritant/corrosive response data for each animal at each observation time of each animal from the test

Score at time point / Reversibility	Cornea	Iris	Conjunctivae	Chemosis
	Max. score: 4	Max. score: 2	Max. score: 3	Max. score: 4
60 min	1/2/2	1/0/0	2/3/2	3/2/2
24 h	2/2/2	1/1/1	3/3/3	2/3/2
48 h	2/2/2	1/1/1	3/3/3	2/2/2
72 h	2/2/2	1/1/1	3/3/3	2/2/2
Average 24h, 48h, 72h	2.00	1.00	3.00	2.11
Area effected	1.44	-	-	-
Reversibility*)	n.	n.	n.	n.
Average time (unit) for reversion	-	-	-	-

 

*) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible

 

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritating to eyes) based on GHS criteria

Conclusions:

Irritant

Executive summary:

The eye irritation of Sodium Toluene-4 sulphonate was assessed following official guideline OECD 405, Acute Eye Irritation/Corrosion.
Dark red erythema, strong swelling and necrotic variations of mucosa and nictitating membrane, all animals. Opacity and hemorrhage on iris, up to 6 days on two animals; strong opacity and strong circumcorneal injection of iris on day 21 still on one animal.
The test item had a moderately irritating effect on the eyes.1 of 3 animals showed irreversible damages at cornea, iris and conjunctivae.