Reaction mass of (2,4,6-trioxo-1,3,5-triazine-1,3,5(2H,4H,6H)-triyl)tri-2,1-ethanediyl triacrylate and 2-Propenoic acid, 1,1'-[[dihydro-5-(2-hydroxyethyl)-2,4,6-trioxo-1,3,5-triazine-1,3(2H,4H)-diyl]di-2,1-ethanediyl] ester

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

January 1994

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1994

Report date:

1994

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

Version / remarks:

1992

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

(2,4,6-trioxo-1,3,5-triazine-1,3,5(2H,4H,6H)-triyl)tri-2,1-ethanediyl triacrylate

EC Number:

254-843-6

EC Name:

(2,4,6-trioxo-1,3,5-triazine-1,3,5(2H,4H,6H)-triyl)tri-2,1-ethanediyl triacrylate

Cas Number:

40220-08-4

Molecular formula:

C18H21N3O9

IUPAC Name:

(2,4,6-trioxo-1,3,5-triazinane-1,3,5-triyl)triethane-2,1-diyl trisacrylate

Test material form:

solid

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Froxfield (UK)
- Age at study initiation: 13 weeks if age
- Weight at study initiation: 2.9 kg
- Housing: individually
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum):ad libitum
- Acclimation period: yes but no details

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 °C
- Humidity (%): 30-70%
- Air changes (per hr): 19
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

100 mg of the test substance was placed into the lower everted lid of one eye of each animal.
The eyelids were ten gently held together for one second before releasing. The contralateral eye remained untreated.

Duration of treatment / exposure:

1 h

Observation period (in vivo):

1 hour and 1 day after exposure

Number of animals or in vitro replicates:

1 animal

Details on study design:

The eyes were examined prior to instillation of the test substance to ensure that there was no pre-existing corneal damage, iridial or conjunctival inflammation.
One animal was treated initially, to ensure that if a severe response was produced, no further animals would be exposed. On this occasion, due to the severity of the reactions, no further animals were used.
The animal was observed daily for signs of ill health or toxicity.
Examination of the eyes was made after 1 hour and on two occasions one day after instillation. Observation of the eyes was aided by the use of a handheld light.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24 h

Score:

2

Max. score:

4

Reversibility:

not reversible

Remarks on result:

positive indication of irritation

Results 2

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24 h

Score:

1

Max. score:

2

Reversibility:

not reversible

Remarks on result:

positive indication of irritation

Results 3

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

animal #1

Time point:

24 h

Score:

3

Max. score:

3

Reversibility:

not reversible

Remarks on result:

positive indication of irritation

Remarks:

associated with necrosis and haemorrhage

Results 4

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24 h

Score:

3

Max. score:

4

Reversibility:

not reversible

Remarks on result:

positive indication of irritation

Remarks:

associated with nictating membrane swollen

Irritant / corrosive response data:

Corneal opacities developed one day after instillation.
Iridial inflammation (grade 2) was observed.
A diffuse crimson or beefy red colouration of the conjunctivae accompanied by swelling with the eyelids more than half closed was seen. Necrosis and haemorrhage was seen on the nictating membrane and lower eyelid. A red/brown discharge was also seen before the animal was killed.
Due to the severity of the reactions, the animal was killed one day after instillation and no further animals were treated.

Other effects:

There were no signs of toxicity or ill health in any rabbit during the observation period.

Applicant's summary and conclusion

Interpretation of results:

Category 1 (irreversible effects on the eye) based on GHS criteria

Conclusions:

Based on the available results, the test substance is considered as severely eye irritating to the rabbit.

Executive summary:

A study was performed to assess the eye irritation of the test substance to the rabbit. One rabbit was administered a single ocular dose of 100 mg of the test substance and observed for one day after instillation. A single installation of the test substance into the eye of the rabbit elicited corneal opacification, severe iridial inflammation and conjunctival reactions. The animal was killed one day after instillation. Based on the available results, the test substance is considered as severely eye irritating to the rabbit.