(carboxymethyl)dimethyl-3-[(1-oxododecyl)amino]propylammonium hydroxide

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1994-12-20

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1995

Report date:

1995

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

Version / remarks:

1992

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

1987

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

1-Propanaminium, 3-amino-N-(carboxymethyl)-N,N-dimethyl-, N-(C8-18(even numbered) and C18 unsaturated acyl) derivs., hydroxides, inner salts

EC Number:

931-333-8

Cas Number:

147170-44-3

Molecular formula:

not applicable

IUPAC Name:

1-Propanaminium, 3-amino-N-(carboxymethyl)-N,N-dimethyl-, N-(C8-18(even numbered) and C18 unsaturated acyl) derivs., hydroxides, inner salts

Test material form:

solid: particulate/powder

Test animals / tissue source

Species:

rabbit

Strain:

other: New Zealand Albino, Chbb: NZW (SPF)

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Age at study initiation: 3-5 month
- Weight at study initiation: 3.3 kg
- Housing: single housing
- Diet: ad libitum, laboratory rabbit diet Altromin 2123 and in addition hay (15 g daily)
- Water: ad libitum, tap water
- Acclimation period: no data


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 50 +/- 20
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 hrs dark/12 hrs light

Test system

Vehicle:

water

Controls:

other: untreated eye served as control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg of test item
- Concentration: applied as delivered by the sponsor (99.4% dry solids)

Duration of treatment / exposure:

eye was not rinsed after treatment

Observation period (in vivo):

1 h

Number of animals or in vitro replicates:

1

Details on study design:

PREPARATION OF ANIMALS
- 24 h before treatment the eye to be treated was examined for corneal lesions under UV light after application of one drop of fluorescein-sodium solution (0.01%)

APPLICATION OF TEST SUBSTANCE
- 100 mg test substance was instilled into the conjunctival sac of the left eye. The untreated right eye served as control.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the treated eye was not rinsed after treatment

SCORING SYSTEM: according OECD 405 (Draize scheme)

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

other: irreversible effects to the eye

Basis:

animal #1

Time point:

other: 1h

Reversibility:

other: animal was humanely killed because of severity of effects after the first scoring one hour after treatment

Remarks on result:

probability of severe irritation

Remarks:

extreme bleeding of conjunctivae and nictating membrane, blood coloured discharge, reddened iris, cornea opacity score 2 of one half of the cornea, iritis score 1, conjunctival erythema and chemosis score 3

Results 2

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Reversibility:

other: animal was humanely killed because of severity of effects after the first scoring one hour after treatment

Remarks on result:

other: extreme bleeding of conjunctivae and nictating membrane, blood coloured discharge, reddened iris, cornea opacity score 2 of one half of the cornea, iritis score 1, conjunctival erythema and chemosis score 3

Results 3

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Reversibility:

other: animal was humanely killed because of severity of effects after the first scoring one hour after treatment

Remarks on result:

other: extreme bleeding of conjunctivae and nictating membrane, blood coloured discharge, reddened iris, cornea opacity score 2 of one half of the cornea, iritis score 1, conjunctival erythema and chemosis score 3

Results 4

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Reversibility:

other: animal was humanely killed because of severity of effects after the first scoring one hour after treatment

Remarks on result:

other: extreme bleeding of conjunctivae and nictating membrane, blood coloured discharge, reddened iris, cornea opacity score 2 of one half of the cornea, iritis score 1, conjunctival erythema and chemosis score 3

Results 5

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Reversibility:

other: animal was humanely killed because of severity of effects after the first scoring one hour after treatment

Remarks on result:

other: extreme bleeding of conjunctivae and nictating membrane, blood coloured discharge, reddened iris, cornea opacity score 2 of one half of the cornea, iritis score 1, conjunctival erythema and chemosis score 3

Irritant / corrosive response data:

1 h after dosing: extreme bleeding of conjunctivae and nictating membrane, blood coloured discharge, reddened iris, cornea opacity score 2 of one half of the cornea, iritis score 1, conjunctival erythema and chemosis score 3. The untreated control eye showed no abnormalities.
After this scoring the animals was humanely killed because of the severity of effects.

Any other information on results incl. tables

Table 1: Irritant/corrosive response data for one animal at each observation time up to removal of each animal from the test

Score at time point / Reversibility	Cornea, - opacity -	Cornea - area-	Iris	Conjunctivae	Chemosis	Discharge
	Max. score 4	Max. score: 4	Max. score: 2	Max. score: 3	Max. score: 4	Max. score: 3
1 h	2	2	1	3	3	2

In addition extreme bleeding of conjunctivae and nictating membrane, blood coloured discharge, reddened iris.

After the 1 h scoring the animals was humanely killed because of the severity of effects.

Applicant's summary and conclusion

Interpretation of results:

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

Conclusions:

Classification is based on effects on the cornea, iris and conjunctiva calculated following grading at 24 hours after instillation of the test material, in consideration of reversibility.
The test substance is considered to cause irreversible effects to the eye according to CLP, EU GHS (Regulation (EC) No 1272/2008).

Executive summary:

In a primary eye irritation study according to EU Method B.5 (1992) and OECD Guideline 405 (1987), 100 mg of Coco AAPB (99.4 % dry solids) was instilled into the conjunctival sac of one New Zealand white rabbit. The eye was not rinsed after test substance instillation. After the first scoring one hour after test substance instillation, the test was terminated. Irritation was scored according to Draize as stipulated in the guidelines.

The treated eye showed 1 h after dosing extreme bleeding of conjunctivae and nictating membrane, blood coloured discharge, reddened iris, cornea opacity score 2 of one half of the cornea, iritis score 1, conjunctival erytheme and chemosis score 3. The untreated control eye showed no abnormalities.

After this scoring the animals was humanely killed because of severity of effects.

In this study, Coco AAPB (99.4 % dry solids) caused irreversible effects on the eye.