Poly(oxy-1,2-ethanediyl), α-[2-(dide- cylmethylammonio)ethyl]- .omega.- hydroxy-, propanoate (salt) (Bardap 26)

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

July 1985

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1985

Report date:

1985

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

Principles of method if other than guideline:

Not applicable.

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

bis(decyl)(2-hydroxyethyl)methylazanium propanoate

EC Number:

619-057-3

Cas Number:

94667-33-1

Molecular formula:

C29 H62 N O4 . C3 H5 O2

IUPAC Name:

bis(decyl)(2-hydroxyethyl)methylazanium propanoate

Constituent 2

Reference substance name:

alpha.-[2-(Didecylmethylammonio)ethyl]-.omega.-hydroxy-poly(oxy-1,2-ethanediyl) propionate

IUPAC Name:

alpha.-[2-(Didecylmethylammonio)ethyl]-.omega.-hydroxy-poly(oxy-1,2-ethanediyl) propionate

Constituent 3

Reference substance name:

N,N-Didecyl-N-methyl-poly(oxyethyl)ammonium Propionate

IUPAC Name:

N,N-Didecyl-N-methyl-poly(oxyethyl)ammonium Propionate

Constituent 4

Reference substance name:

Bardap 26

IUPAC Name:

Bardap 26

Details on test material:

The test material was Bardap 26 described as a clear, yellow liquid. The test substance was stored at 22°C in the dark in a fume hood.

The deviation in composition of the old test material to the current specifications is considered not to have any impact on the outcome of the study.

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

The animals were 3-5 month old New Zealand White rabbits obtained from Hoechst AG, Kastengrund, Germany. The rabbits weighed 2.8-3.7 kg. The animals were housed individually, temperature was maintained at 20 ± 3°C and relative humidity was maintained at 50 ± 20% with a 12 hour light/dark cycle. The rabbits were fed Altromin 2123 Haltungsdiat - Kaninchen ad libitum, and provided with deionised chlorinated water ad libitum.
In-life date was 2 July 1985.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

0.1 ml undiluted test substance/eye

Duration of treatment / exposure:

Single instillation

Observation period (in vivo):

6 hours

Number of animals or in vitro replicates:

3

Details on study design:

24 hours prior to administration, the eyes were examined under a UV-light for potential damage of the cornea after instillation of a drop of sodium fluorescein solution (0.01%). Only animals with normal eyes were used for the study.
A single dose of 0.1 ml of test substance was instilled into the conjunctival sac of the left eye of 3 rabbits. The untreated eyes served as a control.
Eye reactions were evaluated at 1 and 6 hours post-instillation. The study was terminated at 6 hours due to the severity of the effects observed. Reactions were scored according to the system set out in EU Method B.5.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

4

Max. score:

4

Reversibility:

not reversible

Remarks on result:

probability of severe irritation

Remarks:

1 hour post-instillation

Results 2

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

4

Max. score:

4

Reversibility:

not reversible

Remarks on result:

probability of severe irritation

Remarks:

6 hours post-instillation

Results 3

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

3

Max. score:

4

Reversibility:

not reversible

Remarks on result:

other: a clear discharge was observed

Remarks:

1 hour post-instillation

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

4

Max. score:

4

Reversibility:

not reversible

Remarks on result:

other: a clear discharge was observed

Remarks:

6 hours post-instillation

Results 5

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Max. score:

2

Reversibility:

other: tent of conjunctival swelling

Remarks on result:

other: Effects on the iris could not be assessed due to the extent of conjunctival swelling

Remarks:

1 and 6 hours post-instillation

Results 6

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Max. score:

3

Reversibility:

other: Conjunctival redness could not be assessed due to the extent of conjunctival swelling

Remarks on result:

other: Conjunctival redness could not be assessed due to the extent of conjunctival swelling

Remarks:

1 and 6 hours post-instillation

Irritant / corrosive response data:

At 1 and 6 hours post-instillation, the eyes were half closed due to swelling. Corneal opacities (grade 4), conjunctival swelling (grade 3 at 1 hour and grade 4 at 6 hours) and a clear discharge were seen in all animals. Effects on the iris and conjunctival redness could not be assessed because of the extent of the swelling.

Other effects:

No other effects reported.

Any other information on results incl. tables

Table 1. Individual eye irritation scores

Time after application	1 hour			6 hours
Animal No.	1	2	3	1	2	3
Chemosis	3	3	3	4	4	4
Redness	D	D	D	D	D	D
Iris	S	S	S	S	S	S
Opacity	4	4	4	4	4	4
Discharge
- clear	x	x	x	x	x	x
Conjunctivae
- discoloured white	x	x	x	x	x	x

D = evaluation impossible due to severe chemosis and white discolouration

S = evaluation impossible due to severe opacity

Applicant's summary and conclusion

Interpretation of results:

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

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

It was concluded that the test substance is severely irritating to rabbit eyes.

Executive summary:

The eye irritant potential of Bardap 26 was evaluated in 3 New Zealand White rabbits. The rabbits received a single intraocular application of 0.1 ml of the test substance, reactions were evaluated at 1 and 6 hours post-instillation.

At 1 and 6 hours post-instillation, the eyes were half closed, corneal opacity, conjunctival swelling (chemosis) and a clear discharge were seen in all rabbits. Swelling precluded assessment of the iris and conjunctival redness. It was concluded that the test substance is severely irritating to rabbit eyes, and meets the classification criteria for Irreversible Effects on the Eye (Category 1) according to Regulation (EC) No. 1272/2008. The substance is already classified as Skin Corrosion Category 1B with hazard statement H314: Causes severe skin burns and eye damage, therefore additional classification as Irreversible Effects on the Eye (Category 1) with hazard statement H318 is already covered.