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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:
weight of evidence
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

Constituent 1
Chemical structure
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:
sodium 4-methylbenzenesulfonate
Details on test material:
- Name of test material (as cited in study report): Natrium-Toluolsulfonat-Pulver- Physical state: solid (powder)- Storage condition of test material: as dry as possible- Other:Date of production: 1989-05-25

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 daysENVIRONMENTAL CONDITIONS- Temperature (°C): 20 ± 1- Humidity (%): 60 ± 5- Air changes (per hr): 15- Photoperiod (hrs dark / hrs light): 12/12IN-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
Details on study design:
REMOVAL OF TEST SUBSTANCE- Washing (if done): with warm physiological saline- Time after start of exposure: 24 hoursSCORING SYSTEM: according to guidelineTOOL USED TO ASSESS SCORE: ophthalmic lamp, fluorescein 72 hours after administration

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 1, 24, 48 and 72 hours
Score:
31.2
Max. score:
110
Reversibility:
not fully reversible within: 21 days
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 2
Max. score:
4
Reversibility:
fully reversible
Remarks:
6 days
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
ca. 2
Max. score:
4
Reversibility:
not fully reversible within: 21 days
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
ca. 2
Max. score:
4
Reversibility:
fully reversible within: 6 days
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 1
Max. score:
2
Reversibility:
fully reversible within: 6 days
Remarks on result:
other: hemorrhage of the iris
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
ca. 1
Max. score:
2
Reversibility:
not fully reversible within: 21 days
Remarks on result:
other: strong circumcorneal injection of the iris
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
ca. 1
Max. score:
2
Reversibility:
fully reversible within: 6 days
Remarks on result:
other: hemorrhage of the iris
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 3
Max. score:
3
Reversibility:
not fully reversible within: 6 days
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
ca. 3
Max. score:
3
Reversibility:
not fully reversible within: 6 days
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
ca. 3
Max. score:
3
Reversibility:
not fully reversible within: 6 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 2
Max. score:
4
Reversibility:
not fully reversible within: 6 days
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
ca. 2.33
Max. score:
4
Reversibility:
not fully reversible within: 6 days
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
ca. 2
Max. score:
4
Reversibility:
not fully reversible within: 6 days
Irritant / corrosive response data:
AVERAGE SCORE (24, 48 and 72 h)- Cornea: 2.0- Iris: 1.0- Conjunctivae (Redness): 3.0- Conjunctivae (Chemosis): 2.11
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.

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:
moderately irritating
Remarks:
Migrated information Risk of serious damage to eyes Criteria used for interpretation of results: EU
Conclusions:
The test item had a moderately irritating effect on the eyes. 1 of 3 animals showed irreversible damages at cornea, iris and conjunctivae.