Benzethonium chloride

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

July 1995

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:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Benzethonium chloride

EC Number:

204-479-9

EC Name:

Benzethonium chloride

Cas Number:

121-54-0

Molecular formula:

C27H42NO2.Cl

IUPAC Name:

benzyldimethyl(2-{2-[4-(2,4,4-trimethylpentan-2-yl)phenoxy]ethoxy}ethyl)azanium chloride

Test material form:

solid: compact

Specific details on test material used for the study:

TEST MATERIAL
- Sponsor’s identification: P4123
- Batch number: 3072-S
- Date received: 28 June 1995
- Purity: 99.5%
- Description: white powder
- Stability: Considered to be stable under conditions of shipment, storage, and use in this study.
- Storage Conditions: Room temperature in the dark
- Expiration date: no data

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

- Source: David Percival Ltd., Moston, Sandbach, Cheshire, UK,
- Age at study initiation: 12-16 weeks
- Weight at study initiation: 2.78-2.92 kg
- Housing: individually housed in suspended metal cages
- Diet (e.g. ad libitum): STANRAB SQC Rabbit Diet, Special Diets Services Ltd., Witham, Essex, UK
- Water (e.g. ad libitum): tab water
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-22°C
- Humidity (%): 59-74%
- Air changes (per hr): 15 changes/hour
- Photoperiod (hrs dark / hrs light): 12 hours continuous light and 12 hours darkness

Test system

Vehicle:

water

Amount / concentration applied:

For the purpose of this study the test material was diluted to a 0.1% solution in distilled water before use.

Duration of treatment / exposure:

24 hours

Observation period (in vivo):

Assessment of ocular damage/irritation was made approximately 1 hour and 24, 48 and 72 hours following treatment.

Details on study design:

One rabbit was initially treated. A volume of 0.1 ml of the test material was instilled into the conjunctival sac of the right eye, formed by gently pulling the lower lid away from the eyeball. The upper and lower eyelids were held together for about one second immediately after instillation, to prevent loss of the test material, and then released. The left eye remained untreated and was used for control purposes. Immediately after administration of the test material, an assessment of the initial pain reaction was made. After consideration of the ocular responses produced in the first treated animal, two additional animals were treated.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

0.1

Max. score:

1

Reversibility:

fully reversible within: 24 h

Remarks on result:

no indication of irritation

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

No corneal effects were noted during the study. Iridial inflammation was noted in two treated eyes at the 1-hour observation. Minimal conjunctival irritation was noted in all treated eyes at the 1-hour observation and one treated eye at the 24-hour observation. No ocular effects were noted in two treated eyes at the 1-hour observation and the remaining treated eye at the 48-hour observation.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test material did not produce positive criteria in any rabbit according to the GHS regulations. No symbol and P phrases are therefore required.

Executive summary:

A study was performed to assess the irritancy potential of the test material to the eye of the New Zealand White rabbit. The method used followed that described in the OECD Guidelines for Testing of Chemicals No. 405 and Method B5 of Commission Directive 92/69/EEC. A single instillation of a 0.1% solution of the test material to the non-irrigated eye of three rabbits produced iridial inflammation and minimal conjunctival irritation. No ocular effects were noted in two treated eyes at the 24-hour observation and the remaining treated eye at the 48-hour observation. The test material did not meet the criteria for classification as irritant according to GHS regulations.