Registration Dossier

Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
1969-05-06
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1969
Report Date:
1969

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
internal method
Principles of method if other than guideline:
The potential of acute eye irritation was assessed by a single instillation of 0.1 mL test substance into the conjunctival sac of the left eye of nine rabbits. Three eyes were irrigated with tap water two seconds after application, three after four seconds and three eyes were not irrigated, but held closed for one second. During the test, untreated right eyes served as controls. Body weights were recorded both initially and terminally. Corneal demage was proven on day 7, 10 or 14 with 2.0% sodium fluorescein stain. Observations on gross pathology and systematic toxicology were made 24, 48, and 72 hours and 4, 7, 10, and 14 days following application. The acute eye irritation was graded according to Draize, J. H., from the Appraisal of the Safety of Chemicals in Foods, Drugs, and Cosmetics, Assn. of Food and Drug Offcials of the U. S., Austin, Texas, 1959.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
- clear, colorless liquid with a pungent odor
- material assumed to contain 100% active ingredient

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
- Body weight range at initiation: 2.0 to 3.1 kg.
- Diet: Purina Rabbit Chow and water available ad libitum
- eyes judged free of irritation and corneal damage (confirmed by sodium fluorescein examination) prior to initiation of study

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes
other: untreated right eyes served as controls.
Amount / concentration applied:
- 0.1 mL
Duration of treatment / exposure:
- two and four seconds
Observation period (in vivo):
14 days
Number of animals or in vitro replicates:
9 individuals
Details on study design:
- Application of test substance: single application into the conjunctival sac of the left eye
- Posttreatment: 3 eyes irrigated with 20 mL tap water two seconds after application; 3 eyes not irrigated but held closed for 2 seconds

Results and discussion

In vivo

Results
Irritation parameter:
other: histopathological observations
Remarks on result:
other: See "Any other information on results incl. tables"

Any other information on results incl. tables

1. Principal Toxic Effects

On day 4, one animal with the eye irrigated after two seconds died. Several animals blinked and preened themselves immediately after application of the test item. Four animals showed moderate weight loss.

2. Gross Pathology

The following gross signs were observed: Blanched conjunctivae, marked conjunctival erythema in one irrigated eye, slight to marked chemosis and discharge, slight to moderate iritis, and slight to marked corneal opacity was noted from day through day 14. On Day 7, Day 10, and Day 14 corneal vascularization was noted in two eyes irrigated after two seconds. Due to extreme irritation and destruction of the eye, four irrigated eyes and the three nonirrigated eyes could not be completely graded by Day 10 or Day 14.

3. Terminal Fluorescein Examination

Corneal damage was shown on day 14 in two eyes irrigated after two seconds, in two eyes irrigated after four seconds and in the three nonirrigated eyes. Staining was not possible in the remaining two irrigated eyes because the animal died or the eye was destructed completely.

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification