Guanidine, N-phenyl-, compd. with carbonic acid, hydrate (2:1:2)

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

May - June 1992

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Report date:

1992

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

This study has been performed in compliance with Good Laboratory Practice (GLP) in Switzerland, Procedures and Principles, March 1986, issued by the Federal Department of the Interior and the Intercantonal Office for the Control of Medicaments, Switzerlan

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

485-350-6

EC Name:

-

Cas Number:

405095-33-2

Molecular formula:

C15H20N6O3

IUPAC Name:

Carbonic acid - 1-phenylguanidine (1:2)

Test material form:

solid: bulk

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: other (right) eye served as control

Duration of treatment / exposure:

one-time administration

Observation period (in vivo):

21 days

Number of animals or in vitro replicates:

3

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 2

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

not reversible

Results 3

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

not reversible

Results 4

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Max. score:

2

Reversibility:

not fully reversible within: 7 days

Results 5

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1

Max. score:

2

Reversibility:

not reversible

Results 6

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1

Max. score:

2

Reversibility:

not reversible

Results 7

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

2

Max. score:

3

Reversibility:

not reversible

Results 8

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

3

Max. score:

3

Reversibility:

not reversible

Results 9

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Max. score:

3

Reversibility:

not reversible

Results 10

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

2

Max. score:

3

Reversibility:

not reversible

Results 11

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

2

Max. score:

3

Reversibility:

not reversible

Results 12

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 10 days

Results 13

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

not reversible

Results 14

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

not reversible

Irritant / corrosive response data:

Animal 2 has to be killed on day 7 due to proteictive reason
Animal 3 has to be killed on day 7 due to proteictive reason

Any other information on results incl. tables

Bodyweights [g]

Animal No.              663 / M                     513 / M                     753 / M

At start of test	2260	2390	2740
After 3 days	2980	2450	2780
After 7 days	3030	2530*	2890*
After 14 days	3150	--	--
After 21 days (end *)	3190	--	--

M = male

Applicant's summary and conclusion

Interpretation of results:

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

Conclusions:

On account of the irreversible eye reactions observed, CA 1139 A has to be classified as corrosive according to OECD Guideline 405.

Executive summary:

The test was conducted according to OECD guideline 405 in compliance with GLP.

The eye irritatitive/corrosive effects of the substance were investigated in 3 male rabbits.

Under the experimental conditions employed CA 1139 A induced irritation of the cornea, iris and conjunctiva.

One hour after instillation of the test article mydriasis was noticed in the treated eye of all animals. On day 7 corneal bulging, opacity of the lower part of the cornea and pannus was observed in animal No. 513, whereas in animal No. 753 corneal bulging and vascularisation was seen. On day 7 the two animals were killed for animal protective reasons. In animal No. 663 the eye reactions were not reversible until the end of the observation period on day 21.

On account of the irreversible eye reactions observed, CA 1139 A has to be classified as corrosive according to OECD Guideline No. 405.