Amines, N-C12–14 (even numbered)-alkyltrimethylenedi-, reaction products with chloroacetic acid and diethylenetriamine, N-C12–14 (even numbered)-alkyl derivs.

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:

1986

Report date:

1986

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EPA OPP 81-4 (Acute Eye Irritation)

Version / remarks:

40CFR, Subdivision F, Par. 158.50 & 158.135, Section 81-4, pp. 51-55, November, 1982, Primary Eye Irritation

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

2-{[3-(dodecylamino)propyl]amino}acetic acid; {2-[(2-aminoethyl)amino]ethyl}(dodecyl)amine

IUPAC Name:

2-{[3-(dodecylamino)propyl]amino}acetic acid; {2-[(2-aminoethyl)amino]ethyl}(dodecyl)amine

Test material form:

solid - liquid: aqueous solution

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 2-3 kg
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°F): 65-75
- Humidity (%): 40-60
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:

unchanged (no vehicle)

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL

Observation period (in vivo):

21 d

Duration of post- treatment incubation (in vitro):

n.a (treatment group without rinsing)
30 s (treatment group with rinsing)

Number of animals or in vitro replicates:

9 (6 without rinsing, 3 with rinsing)

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): None for animals 1-6, after 30 seconds for animals 7- 9 (rinsing for 1 min with saline)

SCORING SYSTEM: Draize Scale

TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal: 1-6

Remarks:

non-rinsed

Time point:

24/48/72 h

Score:

>= 3.33 - <= 4

Max. score:

4

Reversibility:

not reversible

Remarks on result:

positive indication of irritation

Results 2

Irritation parameter:

cornea opacity score

Basis:

animal: 7-9

Remarks:

rinsed

Time point:

24/48/72 h

Score:

>= 3.33 - <= 3.67

Max. score:

4

Reversibility:

not reversible

Remarks on result:

positive indication of irritation

Results 3

Irritation parameter:

iris score

Basis:

animal: 1-6

Remarks:

non-rinsed

Time point:

24/48/72 h

Score:

2

Max. score:

2

Reversibility:

not reversible

Remarks on result:

positive indication of irritation

Results 4

Irritation parameter:

iris score

Basis:

animal: 7-9

Remarks:

rinsed

Time point:

24/48/72 h

Score:

1.67

Max. score:

2

Reversibility:

not reversible

Remarks on result:

positive indication of irritation

Results 5

Irritation parameter:

conjunctivae score

Basis:

animal: 1-6

Remarks:

non-rinsed

Time point:

24/48/72 h

Score:

3

Max. score:

3

Reversibility:

not reversible

Remarks on result:

positive indication of irritation

Results 6

Irritation parameter:

conjunctivae score

Basis:

animal: 7-9

Remarks:

rinsed

Time point:

24/48/72 h

Score:

>= 2.67 - <= 3

Max. score:

3

Reversibility:

not reversible

Remarks on result:

positive indication of irritation

Results 7

Irritation parameter:

chemosis score

Basis:

animal: 1-6

Remarks:

non-rinsed

Time point:

24/48/72 h

Score:

>= 3.67 - <= 4

Max. score:

4

Reversibility:

not reversible

Remarks on result:

positive indication of irritation

Results 8

Irritation parameter:

chemosis score

Basis:

animal: 7-9

Remarks:

rinsed

Time point:

24/48/72 h

Score:

4

Max. score:

4

Reversibility:

not reversible

Remarks on result:

positive indication of irritation

Irritant / corrosive response data:

The test item produced severe redness and chemosis in 6 of 6 animals in the no rinse group and 3 of 3 animals in the rinse group. The test article produced severe irreversible corneal opacity and iritis in all test animals in both the no rinse and rinse groups. All animals in both test groups developed severe pannus by day 21. Rinsing did not prevent ocular damage.

Other effects:

The test article produced severe pannus in all animals in both the non-rinsed and rinsed groups.

Any other information on results incl. tables

Without rinsing

Score at time point / Reversibility	Cornea	Iris	Conjunctivae	Chemosis
	Max. score: 4	Max. score: 2	Max. score: 3	Max. score: 4
24 h	4/4/3/3/3/4	2/2/2/2/2/2	3/3/3/3/3/3	4/4/4/4/4/4
48 h	4/4/4/3/4/4	2/2/2/2/2/2	3/3/3/3/3/3	4/4/4/4/4/4
72 h	4/4/4/4/4/4	2/2/2/2/2/2	3/3/3/3/3/3	4/4/4/4/3/4
4 d	4/4/4/4/4/4	2/2/2/2/2/2	3/3/3/3/3/3	4/4/4/4/4/4
7 d	4/4/4/4/4/4	2/2/2/2/2/2	3/3/3/3/3/3	4/4/4/3/4/4
14 d	4/4/4/4/4/4	2/2/2/2/2/2	1/1/1/1/1/3	3/3/3/3/3/4
21 d	4/4/4/4/4/4	2/2/2/2/2/2	1/1/1/0/1/3	2/2/2/0/2/4
Average 24h, 48h, 72h	4/4/3.67/3.33/3.67/4	2/2/2/2/2/2	3/3/3/3/3/3	4/4/4/4/3.67/4
Reversibility	Not reversible	Not reversible	Not reversible	Not reversible

 

Eyes rinsed after 30 s

Score at time point / Reversibility	Cornea	Iris	Conjunctivae	Chemosis
	Max. score: 4	Max. score: 2	Max. score: 3	Max. score: 4
24 h	3/4/4	1/1/1	2/3/3	4/4/4
48 h	4/4/4	2/2/2	3/3/3	4/4/4
72 h	3/3/3	2/2/2	3/3/3	4/4/4
4 d	3/3/3	2/2/2	3/3/3	4/3/4
7 d	4/4/4	2/2/2	3/3/3	3/3/3
14 d	4/4/4	2/2/2	1/1/1	2/2/2
21 d	4/4/4	2/2/2	1/1/1	2/2/2
Average 24h, 48h, 72h	3.33/3.67/3.67	1.67/1.67/1.67	2.67/3/3	4/4/4
Reversibility	Not reversible	Not reversible	Not reversible	Not reversible

 

Applicant's summary and conclusion

Interpretation of results:

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

Conclusions:

In this study, Reaction product of lauryl-PDA/lauryl-DETA with chloroacetic acid (22.5% a.i.) caused irreversible damage to the eye.

Executive summary:

In a primary eye irritation study according to EPA OPP 81-4, 0.1 mL of Reaction product of lauryl-PDA/lauryl-DETA with chloroacetic acid (22.5% a.i.) was instilled into the conjunctival sac one eye of 9 New Zealand White rabbits. In 6 animals, the eyes were not rinsed after application, in 3 animals they eyes were rinsed for one minute with saline 30 seconds after application of the test item. Animals were then observed for 21 d.

The test item produced severe redness and chemosis in 6 of 6 animals in the no rinse group and 3 of 3 animals in the rinse group. The test article produced severe irreversible corneal opacity and iritis in all test animals in both the no rinse and rinse groups. All animals in both test groups developed severe pannus by day 21. Rinsing did not prevent ocular damage.

In this study, Reaction product of lauryl-PDA/lauryl-DETA with chloroacetic acid (22.5% a.i.) caused irreversible damage to the eye.