Reaction mass of sodium (methylbutyl and pentyl) sulfonate and sodium 1,2-bis(pentyloxycarbonyl)ethanesulphonate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1957

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The study was not performed under GLP compliance, however, the study was conducted according to standards of that time, therefore the study is considered to be adequate, reliable and relevant.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1957

Report date:

1957

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

no scoring, observation period 7 days

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

trisodium 1,4-dioxo-1,4-bis(pentyloxy)butane-2-sulfonate pentane-1-sulfonate pentane-2-sulfonate

EC Number:

941-224-7

Molecular formula:

C14H25O7S.Na

IUPAC Name:

trisodium 1,4-dioxo-1,4-bis(pentyloxy)butane-2-sulfonate pentane-1-sulfonate pentane-2-sulfonate

Test material form:

other: waxy solid

Details on test material:

- Name of test material (as cited in study report): Aerosol AY
- Physical state: White, waxy solid
- Analytical purity: >97%
- Impurities (identity and concentrations): See confidential details
- Composition of test material, percentage of components: See confidential details
- Isomers composition: Not provided
- Purity test date: Not provided
- Lot/batch No.: SPS 900A-MH and additional samples without No
- Expiration date of the lot/batch: Not provided
- Stability under test conditions: Not provided
- Storage condition of test material: Not provided

Test animals / tissue source

Species:

rabbit

Strain:

other: albino

Details on test animals or tissues and environmental conditions:

Not provided

Test system

Controls:

no

Amount / concentration applied:

10 mg

Duration of treatment / exposure:

30 seconds (eyelids held close)

Observation period (in vivo):

7 days

Number of animals or in vitro replicates:

5 male albino rabbits

Details on study design:

A quantity of approximately 10 mg of the product was placed in the conjunctival sac of the left eye of each of 5 male albino rabbits. The lids were held close for about 30 seconds after introduction of the dose, and the eye was examined immediately thereafter, and again over the next several days.

Results and discussion

In vivo

Results

Remarks on result:

other: No scores available

Irritant / corrosive response data:

There was an immediate reaction of pain or discomfort to application of the dose, but no more serious sign of immediate injury than a somewhat excessive amount of lacrimation. By 24 hours after the dose a moderate degree of conjunctivitis had developed. This subsided gradually over the succeeding 24 to 48 hours and was associated with a certain amount of discharge from the eye. By the fourth day following that of the dose, most eyes had regained their normal appearance, and continued in good condition for the remainder of a seven-day observation period.

Applicant's summary and conclusion

Interpretation of results:

irritating

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

Introduction of small quantities of the test item containing >97% active ingredient into the rabbit eye resulted in a moderate to severe conjunctivitis of several days duration, but no further injury.

Executive summary:

A quantity of approximately 10 mg of the test item containing > 97% active ingredient was placed in the conjunctival sac of the left eye of each of 5 male albino rabbits. The lids were held close for about 30 seconds after introduction of the dose, and the eye was examined immediately thereafter, and again over the next several days.There was an immediate reaction of pain or discomfort to application of the dose, but no more serious sign of immediate injury than a somewhat excessive amount of lacrimation. By 24 hours after the dose a moderate degree of conjunctivitis had developed. This subsided gradually over the succeeding 24 to 48 hours and was associated with a certain amount of discharge from the eye. By the fourth day following that of the dose, most eyes had regained their normal appearance, and continued in good condition for the remainder of a seven-day observation period.