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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 guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report date:
1998

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Version / remarks:
EEC Guideline 92/69/EEC
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
1,3,5-triazine-2,4,6(1H,3H,5H)-trithione, trisodium salt
EC Number:
241-749-5
EC Name:
1,3,5-triazine-2,4,6(1H,3H,5H)-trithione, trisodium salt
Cas Number:
17766-26-6
Molecular formula:
C3N3S3.3Na
IUPAC Name:
1,3,5-triazine-2,4,6(1H,3H,5H)-trithione, trisodium salt

Test animals / tissue source

Species:
rabbit
Strain:
Himalayan
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Age at study initiation: 33 - 39 months
- Weight at study initiation: females 2.69 - 2.74 kg
- Housing: 1 animal/cage
- Diet: approx. 120 g/animal/day, Standard diet, ssniff K-Z, complete diet for rabbits - breeding (ssniff Spezialdiäten GmbH, Soest, Germany)
- Water: tap water, ad libitum
- Acclimation period: at least 1 day

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18.0 - 19.5
- Humidity (%): 54 - 87
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From 02 June 1998 To 23 June 1998

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye of the same animal served as control
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 68.6 mg, 75.7 mg, 84.3 mg (representing a volume of ca. 0.1 mL)

Duration of treatment / exposure:
single application without washing
Observation period (in vivo):
6, 10 or 21 days after application
Reading time points: 1, 24, 48 and 72 hours after application, thereafter once daily
Number of animals or in vitro replicates:
3 females
Details on study design:
SCORING SYSTEM: Draize scoring system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: mean over 24, 48 and 72 h
Score:
1.67
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: mean over 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not applicable
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: mean over 24, 48 and 72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: mean over 24, 48 and 72 h
Score:
0.33
Max. score:
2
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: mean over 24, 48 and 72 h
Score:
0
Max. score:
2
Reversibility:
other: reversibility not applicable
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: mean over 24, 48 and 72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 5 days
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: mean over 24, 48 and 72 h
Score:
3
Max. score:
3
Reversibility:
not fully reversible within: 21 days
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: mean over 24, 48 and 72 h
Score:
1.67
Max. score:
3
Reversibility:
fully reversible within: 6 days
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: mean over 24, 48 and 72 h
Score:
3
Max. score:
3
Reversibility:
fully reversible within: 10 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: mean over 24, 48 and 72 h
Score:
2.67
Max. score:
4
Reversibility:
not fully reversible within: 21 days
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: mean over 24, 48 and 72 h
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 5 days
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: mean over 24, 48 and 72 h
Score:
2.33
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritant / corrosive response data:
The cornea of one animal showed easily discernible translucent areas of opacity (grade 2) in more than three quarters of the cornea. Details of iris were slightly obscured. In a second rabbit only scattered diffuse opacity was recorded in more than three quarters of the cornea. The iris was clearly visible. The findings in these two animals were reversible within 7 days after instillation of the test item. The third rabbit did not show any corneal lesions.
Changes of the iris, namely moderate circumcorneal hyperemia (grade 1) were found in two animals between 1 and 4 days after treatment.
The conjunctiva reacted with reddening and swelling in all three rabbits. Diffuse crimson discolouration (grade 2) to beefy redness (grade 3) was present 1 hour after treatment. One animal recovered within 6 days, while slight redness (grade 1) remained in a second animal for the total observation period of 21 days and in a third animal for 9 days. Swelling also developed within 1 hour in all rabbits. In two animals grade 3 with eyes about half closed was the maximum severity. The finding disappeared within 7 days in one animal and was still present in a second animal after 21 days while a third animal showed only slight swelling (grade 1) until day 4 after treatment.
Additional lesions were slight to considerable discharge moistening lids and hairs around the eye, white mucous in the eye and light brown discolouration of the rim of the lower lid.
The irritation index derived in the original study report is 29, corresponding to moderately irritant in this test system. Although one animal had not recovered completely within the 21-day observation period, the findings clearly showed a tendency to recovery. In the other two animals all changes were reversible within 5 to 9 days of the observation period.
Other effects:
There were no systemic effects after conjunctival application of the test substance.

Applicant's summary and conclusion

Interpretation of results:
Category 2A (irritating to eyes) based on GHS criteria
Remarks:
Migrated information: for hydrated form TMT 55
Conclusions:
Under the conditions of this eye irritation study in the rabbit the test item TMT 55 caused strong irritation to the eye.