1,3-di-o-tolylguanidine

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:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1975

Report date:

1975

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

Method: Draize

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

1,3-di-o-tolylguanidine

EC Number:

202-577-6

EC Name:

1,3-di-o-tolylguanidine

Cas Number:

97-39-2

Molecular formula:

C15H17N3

IUPAC Name:

1,3-di-o-tolylguanidine

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

Animals were caged individually and receive no hay or others extraneous material that might enter the eyes.

Test system

Vehicle:

unchanged (no vehicle)

Remarks:

undiluted

Controls:

other: yes, the second eye

Amount / concentration applied:

Amount applied: 100 mg

Duration of treatment / exposure:

not applicable

Observation period (in vivo):

24, 48, 72 hours and 7 days after instillation of the test material.

Number of animals or in vitro replicates:

6 rabbits

Details on study design:

The eyes of the animals are examined before testing and only those animals without observable eye defacts are used.
The eyes are not washed loffowing the instillation and the animals are released immediately.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

6 rabbits

Time point:

24/48/72 h

Score:

0.39

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 2

Irritation parameter:

iris score

Basis:

mean

Remarks:

6 rabbits

Time point:

24/48/72 h

Score:

0.39

Max. score:

2

Reversibility:

fully reversible within: 7 days

Results 3

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

mean

Remarks:

6 rabbits

Time point:

24/48/72 h

Score:

1.6

Max. score:

4

Reversibility:

not fully reversible within: 7 days

Remarks on result:

other: Scores at day 7 are 1.

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

6 rabbits

Time point:

24/48/72 h

Score:

1.56

Max. score:

4

Reversibility:

not fully reversible within: 7 days

Remarks on result:

other: Scores at day 7 are 1.

Irritant / corrosive response data:

Twenty four hours after DOTG had been brought into the eyes, slight corneal damage was observed in three out of six rabbits, slight iritis in four out od six rabbits and slight or moderate conjunctivitis in all test rabbits. The eye lesions recovered gradually but incompletely, so what at the seventh day reading slight conjunctivitis was still observed in three out of 6 rabbits.

Other effects:

no data

Any other information on results incl. tables

Table of results: Eye irritation test

Individual scores awarded to the ocular reactions elicited by DOTG.

 

Rabbit n°	cornea	iris	Conjunctivae (redness)	Conjunctivae (chemosis)
AFTER 24 HOURS
1	1	1	2	3
2	1	1	2	2
3	0	1	2	2
4	0	0	1	1
5	1	1	2	3
6	0	0	1	2
AFTER 48 HOURS
1	1	1	2	2
2	1	1	2	1
3	0	0	2	1
4	0	0	1	0
5	1	0	2	2
6	0	0	1	2
AFTER 72 HOURS
1	1	0	2	2
2	0	1	2	1
3	0	0	1	1
4	0	0	1	0
5	1	0	2	2
6	0	0	1	1
AFTER 7 DAYS
1	0	0	0	0
2	0	0	1	1
3	0	0	1	1
4	0	0	0	0
5	0	0	1	1
6	0	0	0	0

 

 

Table no.2 of results :

 

Rabbits no.	Duration of observation	cornea	iris	Conjunctivae / redness	Conjunctivae / chemosis
1	Mean 24-48-72 hours	1	0.67	2	2.33
2		0.67	1	2	1.33
3		0	0.33	1.67	1.33
4		0	0	1.33	0.33
5		0.33	0.33	1.67	2.33
6		0	0	1.33	1.67

 

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Remarks:

not eye irritating according to CLP

Conclusions:

According this study, DOTG is a slightly eye irritant in rabbits.

Executive summary:

DOTG was examined for possible eye irritating properties in rabbits. DOTG was applied to rabbit (100 mg) and rabbits were observed at 1, 24, 48, 72 hours and 7 days.

DOTG caused slight corneal damage in three out of 6 rabbits, slight iritis in four out of 6 rabbits, and slight or moderate conjunctivitis in all test rabbits. In conclusion, DOTG is slightly irritant for eyes.