3,5,8-Trioxa-4-phosphaundec-10-en-1-aminium, 4-hydroxy-N,N,N,10-tetramethyl-9-oxo-, inner salt, 4-oxide

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

other: Letter of Access (See Section 13)

Adequacy of study:

key study

Data source

Reference

Reference Type:

other: Letter of Access (See Section 13)

Title:

Unnamed

Year:

1995

Report date:

1995

Materials and methods

Test guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

not specified

Remarks:

Letter of Access Only

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

417-560-0

EC Name:

-

Cas Number:

67881-98-5

Molecular formula:

C11H22NO6P

IUPAC Name:

trimethyl[2-({2-[(2-methylprop-2-enoyl)oxy]ethyl phosphonato}oxy)ethyl]azanium

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

Information not available, letter of access only

Test system

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

Approximately 33 mg per animal

Observation period (in vivo):

Observations were made at 24, 48 and 72 hours after exposure.

Number of animals or in vitro replicates:

3 animals

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal #1

Remarks:

mean value

Time point:

other: 24 - 72 hours

Score:

0.7

Max. score:

2

Reversibility:

fully reversible

Results 2

Irritation parameter:

conjunctivae score

Remarks:

mean value

Basis:

animal #2

Time point:

other: 24 - 72 hours

Score:

0

Max. score:

0

Results 3

Irritation parameter:

conjunctivae score

Remarks:

mean value

Basis:

animal #3

Time point:

other: 24 - 72 hours

Score:

0.3

Max. score:

1

Reversibility:

fully reversible

Results 4

Irritation parameter:

chemosis score

Basis:

other: All Animals and time points

Score:

0

Max. score:

0

Results 5

Irritation parameter:

cornea opacity score

Basis:

other: All animals and time points

Score:

0

Max. score:

0

Results 6

Irritation parameter:

iris score

Basis:

other: All animals and time points

Score:

0

Max. score:

0

Irritant / corrosive response data:

Refer to Table 1.

Other effects:

None.

Any other information on results incl. tables

A diffuse, crimson colouration of the conjunctivae was seen in one animal. Transient hyperaemia of blood vessels was seen in the remaining two animals. No evidence of chemosis was seen in any of the animals. The conjunctival inflammation had resolved completely by one or two days after treatment.

Table 1. Overall Results (showing individual scores if < 3 animals) calculated on the basis of the scores for each animal at 24, 48 and 72 hours.

	Animal	Mean Score	Maximum Value	Maximum Duration of any Effect	Maximum value at the end of the observation period
Conjunctiva / redness	1 2 3	0.7 0 0.3	2	48 hours	0
Conjunctiva / chemosis	1 2 3	0 0 0	0		0
Cornea	1 2 3	0 0 0	0		0
Iris	1 2 3	0 0 0	0		0

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: OECD GHS

Conclusions:

This study indicated that HEMA-PC is not irritating to the eyes.

Executive summary:

This study was conducted to determine whether HEMA-PC was irritating to the eyes using OECD Guideline 405 (Acute Eye Irritation/Corrosion).

This study indicated that HEMA-PC is not irritating to the eyes.