6-nonyl-1,3,5-triazine-2,4-diamine

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:

1977

Report date:

1977

Materials and methods

Test guideline

Test guideline 1

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

02 October 2012

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: FDA (Fed. Reg. 28 (119), 5582, 1963

Test guideline 3

Qualifier:

according to guideline

Guideline:

other: Draize and Kelley (Drug Cosmet. Industr. 71 (1952) 36)

GLP compliance:

no

Remarks:

study performed before implementation of GLP

Test material

Test material information

Constituent 1

Reference substance name:

6-nonyl-1,3,5-triazine-2,4-diamine

EC Number:

227-645-2

EC Name:

6-nonyl-1,3,5-triazine-2,4-diamine

Cas Number:

5921-65-3

Molecular formula:

C12H23N5

IUPAC Name:

6-nonyl-1,3,5-triazine-2,4-diamine

Test material form:

solid: bulk

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Age at study initiation: adult
- Housing: caged individually and recieved no hay or other extranous material that might enter eyes

Test system

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg

Duration of treatment / exposure:

7 days

Observation period (in vivo):

7 days

Number of animals or in vitro replicates:

6

Details on study design:

REMOVAL OF TEST SUBSTANCE
- the eyes were not washed following instillation

SCORING SYSTEM: FDA scoring scale

TOOL USED TO ASSESS SCORE: binocular magnifying glass, confirmation of corneal damage by flourescein staining if necessary

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal: #1, #2, #4, #5, #6

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 h

Results 3

Irritation parameter:

iris score

Basis:

animal: #1, #2, #4, #5, #6

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 4

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.33

Max. score:

2

Reversibility:

fully reversible within: 48 h

Results 5

Irritation parameter:

conjunctivae score

Basis:

animal: #1, #4

Time point:

24/48/72 h

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 48 h

Results 6

Irritation parameter:

conjunctivae score

Basis:

animal: #2, #5

Time point:

24/48/72 h

Score:

0.66

Max. score:

3

Reversibility:

fully reversible within: 72 h

Results 7

Irritation parameter:

conjunctivae score

Basis:

animal: #3, #6

Time point:

24/48/72 h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 7 d

Results 8

Irritation parameter:

chemosis score

Basis:

animal: #1, #2, #4

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 9

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.66

Max. score:

4

Reversibility:

fully reversible within: 7 d

Results 10

Irritation parameter:

chemosis score

Basis:

animal #5

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 h

Results 11

Irritation parameter:

chemosis score

Basis:

animal #6

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 72 h

Irritant / corrosive response data:

24 hours after Caprinoguanamine had been brought into the eyes very slight corneal opacity and slight iritis in one rabbit and slight conjunctivitis in all six rabbits were observed. In the course of the seven day observation period all lesions recovered completely, so that at the seventh day reading all eyes were normal again.

Any other information on results incl. tables

Individual scores awarded to the ocular lesions elicited by Caprinoguanamine:

Score time point	Cornea (max score 4)	Iris (max. score 2)	Conjunctivae (max. score 3)	Chemosis (max. score 4)
24 hours	0/0/1/0/0/0	0/0/1/0/0/0	1/1/1/1/1/1	0/0/1/0/1/0
48 hours	0/0/0/0/0/0	0/0/0/0/0/0	0/1/1/0/1/1	0/0/0/0/0/1
72 hours	0/0/0/0/0/0	0/0/0/0/0/0	0/0/1/0/0/1	0/0/1/0/0/0
7 days	0/0/0/0/0/0	0/0/0/0/0/0	0/0/0/0/0/0	0/0/0/0/0/0

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

24 hours after Caprinoguanamine had been brought into the eyes very slight corneal opacity and slight iritis in one rabbit and slight conjunctivitis in all six rabbits were observed. In the course of the seven day observation period all lesions recovered completely, so that at the seventh day reading all eyes were normal again.

Executive summary:

In a primary eye irritation study similar to OECD guideline 405, 2nd October 2012, 100 mg of Caprinoguanamine was instilled into the conjunctival sac of 6 adult New Zealand white rabbits. Animals then were observed for 7 days. Irritation was scored by the FDA scoring scale. 24 hours after Caprinoguanamine had been brought into the eyes very slight corneal opacity and slight iritis in one rabbit (score 1) and slight conjunctivitis (score 1) in all six rabbits were observed. All lesions were fully reversible within the 7 day observation period.

In this study the mean grades of ocular reactions at 24, 48 and 72 h after instillation were lower than the values classified as irritant by the Directive 67/548/EEC as well as GHS Regulation EC No 1272/2008.

When administered to the eye, the test article Caprinoguanamine is classified as "non-irritant".