Registration Dossier

Toxicological information

Eye irritation

Currently viewing:

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.
Cross-reference
Reason / purpose for cross-reference:
reference to same study

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

Constituent 1
Chemical structure
Reference substance name:
Sodium 1,2-bis(pentyloxycarbonyl)ethanesulphonate
EC Number:
213-085-6
EC Name:
Sodium 1,2-bis(pentyloxycarbonyl)ethanesulphonate
Cas Number:
922-80-5
Molecular formula:
C14H26O7S.Na
IUPAC Name:
sodium 1,4-dioxo-1,4-bis(pentyloxy)butane-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:
Migrated information 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.