3-(N-p-methoxy cinnamidopropyl-N,N-dimethyl ammonium)-2-hydroxypropane-1-sulphonate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

30th July 2001

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study conducted in accordance with generally accepted scientific principles, possibly with incomplete or methodological deficiencies, which do not affect the quality of relevant results.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2001

Report date:

2001

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

other: Gaitonde Committee Guidelines

Deviations:

no

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

2-hydroxy-3-({3-[(2E)-3-(4-methoxyphenyl)prop-2-enamido]propyl}dimethylazaniumyl)propane-1-sulfonate

EC Number:

695-243-8

Cas Number:

500731-87-3

Molecular formula:

C18H28N2O6S

IUPAC Name:

2-hydroxy-3-({3-[(2E)-3-(4-methoxyphenyl)prop-2-enamido]propyl}dimethylazaniumyl)propane-1-sulfonate

Test material form:

other: liqiud

Details on test material:

Test material: Galaxy Sunbetaine

Characteristics of the test material:
Physical state: Liquid
Quantity Recd: 100 ml x 01 bottle
Colour: Clear
Batch no. BP-07-24 laboratory batch
Date of Manufacture: July 2001
Date of expiry: NIL
Date of reciept of sample: 28th July 2001

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

Test Animal:

Species: Albino rabbits
Strain: New Zealand White
Source: National Toxicology Centre
Weight range: 1.7 to 2.1 kg
Age: 6 to 9 weeks
Sex: male and female
Number: 3 per sex
Housing: The animals were housed singly
Diet: Pelleted feed supplied by Nav Maharasthra Chakan Oil Mills Ltd., Pune
Water: Community tap water ad libitum
Room temperature: 19 to 22 degrees Celsius
Relative humidity: 35 to 75%
Lighty cycle: 12 hours day 12 hours dark

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

The test material in the amount of 0.10 ml was placed directly into animals eye. The other eye was untreated as a control.

Duration of treatment / exposure:

Once the test material was applied the eyelid was held down for two seconds to prevent loss of test substance.

Observation period (in vivo):

Each eye was carefully examined, observed at 24, 48 and 72 hours and the observations extended to determine the reversibility or irreversibility.

Number of animals or in vitro replicates:

Six rabbits, three per sex were used for this study.

Details on study design:

Six rabbits, three per sex, were used for this study. The test material in the amount of 0.10 ml was placed in the conjuctival sac of one eye of each animal after gently pulling the lower lid away from the eyeball. The lids were then gently held together for approximately two seconds in order to prevent the loss of the test material. The other eye remained untreated and served as a control. The animals were housed singly.

Clinical Observations:
Each eye was carefully examined, observed at 24, 48 and 72 hours and the observations extended to deterimine the reversibility or irreversibility. Any redness, chemosis and discharge was recorded.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 72 hours

Score:

0

Max. score:

4

Reversibility:

not specified

Remarks:

Not applicable as overall irritation score = 0

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

iris score

Basis:

mean

Remarks:

all animals

Time point:

24/48/72 h

Score:

0

Results 3

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

all animals

Time point:

24/48/72 h

Score:

0

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

all animals

Time point:

24/48/72 h

Score:

0

Results 5

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

all animals

Time point:

24/48/72 h

Score:

0

Irritant / corrosive response data:

Irritaion score = 0

Other effects:

None observed

Any other information on results incl. tables

A summary of the individiual irritant response following application of "Galaxy Sunbetaine"

Rabbit No.	Sex	Cornea	Iris	Conjuctivae
				Redness	Chemosis	Discharge
1	M	0	0	0	0	0
2	M	0	0	0	0	0
3	M	0	0	0	0	0
4	F	0	0	0	0	0
5	F	0	0	0	0	0
6	F	0	0	0	0	0

 

Hours                         24                   48              72

SCORE                      0                    0                 0

Grand Total: 0.00

Where 0 = no reaction

Irritation Score: 0.00

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test material "Galaxy Sunbetaine" caused no irritation to the eye in rabbits.

The test material is termed as non-irritant.

Executive summary:

The objective of the study was reported here was to determine the mucous membrane irritation potential of "Galaxy Sunbetaine" in rabbits following the Gaitonde Committee Protocol.

The test material in the amount of 0.10 ml was instilled in the conjuctival sac of one eye of each animal. Each eye was carefully observed and the reaction evaluated at 24, 48 and 72 hours post instillation.

The test material caused no irritation to the eye in rabbits.