N,N,N',N',N'',N''-hexamethyl-1,3,5-triazine-1,3,5(2H,4H,6H)-tripropanamine

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:

other: Comparable to guideline study, acceptable for assessment.

Data source

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

1975

Report date:

1975

Reference 2

Reference Type:

other company data

Title:

Unnamed

Year:

2002

Report date:

2002

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

Only 0.05 mL applied (instead of 0.1 mL), observation period: only 8 days (instead of 21 days)

Principles of method if other than guideline:

The study was conducted following a protocol based on BASF-internal standards.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

N,N,N',N',N'',N''-hexamethyl-1,3,5-triazine-1,3,5(2H,4H,6H)-tripropanamine

EC Number:

240-004-1

EC Name:

N,N,N',N',N'',N''-hexamethyl-1,3,5-triazine-1,3,5(2H,4H,6H)-tripropanamine

Cas Number:

15875-13-5

Molecular formula:

C18H42N6

IUPAC Name:

(3-{3,5-bis[3-(dimethylamino)propyl]-1,3,5-triazinan-1-yl}propyl)dimethylamine

Details on test material:

Name of the test substance used in the study report: Triazin (= HM 17 994)

Test animals / tissue source

Species:

rabbit

Strain:

Vienna White

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated eye of the same animal

Amount / concentration applied:

0.05 ml

Duration of treatment / exposure:

once

Observation period (in vivo):

8 d

Number of animals or in vitro replicates:

2

Details on study design:

REMOVAL OF TEST SUBSTANCE
- not rinsed

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

other: 24-48 h

Score:

3

Max. score:

4

Reversibility:

not reversible

Remarks on result:

other: no assessment was possible after 72 h due to a clotted eye

Results 2

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

other: 24-48 h

Score:

3

Max. score:

4

Reversibility:

not reversible

Remarks on result:

other: no assessment was possible after 72 h due to a clotted eye

Results 3

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

other: 24-48 h

Score:

1

Max. score:

4

Reversibility:

not reversible

Remarks on result:

other: no assessment was possible after 72 h due to a clotted eye

Results 4

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

other: 24-48 h

Score:

1

Max. score:

4

Reversibility:

not reversible

Remarks on result:

other: no assessment was possible after 72 h due to a clotted eye

Results 5

Irritation parameter:

iris score

Basis:

animal #1

Time point:

other: 24-48 h

Score:

0.5

Max. score:

2

Reversibility:

not reversible

Remarks on result:

other: no assessment was possible after 72 h due to a clotted eye

Results 6

Irritation parameter:

iris score

Basis:

animal #2

Time point:

other: 24-48 h

Score:

1.5

Max. score:

2

Reversibility:

not reversible

Remarks on result:

other: no assessment was possible after 72 h due to a clotted eye

Results 7

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

other: 24-48 h

Score:

1.5

Max. score:

3

Reversibility:

not reversible

Remarks on result:

other: no assessment was possible after 72 h due to a clotted eye

Results 8

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

other: 24-48 h

Score:

2

Max. score:

3

Reversibility:

not reversible

Remarks on result:

other: no assessment was possible after 72 h due to a clotted eye

Any other information on results incl. tables

Table 1: Individual findings after investigation of animals for eye irritation after exposure to test substance:

 

Readings	Animals	Cornea	Iris	Conjunctiva			Additional findings
		Opacity		Redness	Chemosis	Discharge
24 h	1	3	-	1	1	-	nictitating membrane reddish brown, pus
	2	3	1	2	1	-	scleral vessels injected, nictitating membrane grey, mucous membrane reddish brown, lubricious overlay
48 h	1	3	1	2	1	-	Ciliar injection, eye clotted, pus formation, nictitating membrane grey, mucous membrane reddish brown
	2	3	2	2	1	-	Iritis, eye clotted, pus formation, nictitating membrane grey, mucous membrane reddish brown
72 h	1						eye clotted, no observation possible
	2						eye clotted, no observation possible
Mean 24-48 h	1	3	0.5	1.5	1	-
	2	3	1.5	2	1	-
Mean
8 d	1	3	2	2	1	-	Iritis, nictitating membrane and mucous membrane white and thick, staphyloma, pus formation
	2	3	2	1	1	-	Iritis, nictitating membrane partly white, mucous membrane reddish brown, staphyloma, lubricious overlay

Applicant's summary and conclusion

Interpretation of results:

Category 1 (irreversible effects on the eye)

Remarks:

Migrated information

Conclusions:

The substance induced irreversible effects on the eye.

Executive summary:

The substance induced irreversible effects on the eye.