Hydantoin

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

05.10.-30.10.1992

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1993

Report date:

1993

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

1987

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Hydantoin

EC Number:

207-313-3

EC Name:

Hydantoin

Cas Number:

461-72-3

Molecular formula:

C3H4N2O2

IUPAC Name:

hydantoin

Test material form:

solid: particulate/powder

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Rosemead Rabbits, Rosemead, Waltham Abbey, Essex, England
- Age at study initiation: three and a half to four months
- Weight at study initiation: 2.83 - 3.16 kg
- Housing: individually in suspended stainless steel cages mounted in mobile batteries
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 21 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18°C (range 15°-23°C)
- Humidity (%): 55% R.H. {range 40%-70% R.H.)
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 26.10.1992 To: 30.10.1992

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

0.1 g

Duration of treatment / exposure:

72 h

Observation period (in vivo):

72 h

Number of animals or in vitro replicates:

3

Details on study design:

SCORING SYSTEM: Draize Eye Test
TOOL USED TO ASSESS SCORE: ophthalmoscope

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

0.43

Max. score:

3

Reversibility:

fully reversible

Remarks on result:

probability of mild irritation

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

lnjection of the conjunctival blood vessels or a diffuse crimson-red conjunctival appearance was observed in all rabbits during the first 48 hours following instillation of Hydantoin. Very slight discharge was observed in the treated eye of each rabbit at the one hour examination. One rabbit also displayed iritis and very slight chemosis at this time.
The test eye of two rabbits was overtly normal at the 48 hour examination and the third by the 72 hour examination.
Instillation of the test material caused a slight or moderate initial pain response.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The potential of Hydantoin to cause eye damage was assessed in three New Zealand White rabbits, each subjected to a single ocular instillation of 0.1 g of the test material. Slight irritation was observed up to 48 h after instillation, all animals recovered by maximum 72 hours. Under the criteria of GHS, Hydantoin was classified as non-irritant to the eye.