Tris(2-hydroxyethyl)-1,3,5-triazinetrione

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:

other: according to information in OECD SIDS (2002)

Data source

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

1976

Report date:

1976

Reference 2

Reference Type:

publication

Title:

Unnamed

Year:

2002

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

; 50 mg instead of 100 mg test substance instilled

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Tris(2-hydroxyethyl)-1,3,5-triazinetrione

EC Number:

212-660-9

EC Name:

Tris(2-hydroxyethyl)-1,3,5-triazinetrione

Cas Number:

839-90-7

Molecular formula:

C9H15N3O6

IUPAC Name:

tris(2-hydroxyethyl)-1,3,5-triazinane-2,4,6-trione

Details on test material:

- Name of test material (as cited in study report): THEIC
- Physical state: solid
- Analytical purity: ca. 99%

Test animals / tissue source

Species:

rabbit

Strain:

Vienna White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Gaukler (breeder)
- Weight at study initiation: 2.98 and 3.09 kg


ENVIRONMENTAL CONDITIONS
not reported

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: 50 mg talcum into the other eye

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit):
50 mg into the conjunctival sac of one eye per rabbit. The contralateral eye received 50 mg talcum to serve as a control.

Duration of treatment / exposure:

Once. There was no mentioning in the raw data or report that eyes were rinsed after treatment. Consequently the treatment/exposure period was equivalent to the entire observation period following administration, which was 8 days, or lasted until removal of the test material by physiological mechanisms, whichever happened sooner.

Observation period (in vivo):

8 days (observations at 10 min, 1 h, 3h, 1, 2, 3, 4, 7 and 8 days post instillation)

Number of animals or in vitro replicates:

2

Details on study design:

SCORING SYSTEM:
Descriptive grading in the raw data: no effect / questionable / slight / strong / very strong.
In addition, indication of the type of finding as appropriate: erythema / edema / scale formation / necrosis / opacity / scar.
The descriptive scores in the raw data were converted into OECD/ Draize scores.

FLUORESCEIN:
On day 8 staining with fluorescein to support eye evaluation.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 3

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 4

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 5

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.67

Max. score:

3

Reversibility:

fully reversible within: 48 h

Results 6

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.67

Max. score:

3

Reversibility:

fully reversible within: 48 h

Results 7

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 8

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Other effects:

Secretion was noted in one animal at 10 min post instillation in the other animal at 1 h post instillation, but was no longer seen thereafter.

Any other information on results incl. tables

 

Animal	Reading	Opacity	Iritis	Redness	Chemosis	Comment
1	1 h	0	0	1	0	Secretion
2	1 h	0	0	1	0
1	24 h	0	0	0	0
2	24 h	0	0	0	0
1	48 h	0	0	1	0
2	48 h	0	0	1	0
1	72 h	0	0	1	0
2	72 h	0	0	1	0
1	4 d	0	0	1	0
2	4 d	0	0	1	0
1	7 d	0	0	1	0
2	7 d	0	0	1	0
1	8 d	0	0	1	0	score before application of fluorescein
2	8 d	0	0	0	0	score before application of fluorescein
1	8 d	0	0	0	0	score after application of fluorescein
2	8 d	0	0	0	0	score after application of fluorescein
mean	24 - 72 h	0.00	0.00	0.67	0.00

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU