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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
26 March 1985 to 29 March 1985
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Due to the pyrophoric nature of the test material, the test was abandoned after testing the initial animal. The results indicate that, despite causing burns around the eye due to the ignition of the animal's hair, the test material is not irritating to the eye; however, the information is not sufficient for classification and labelling purposes due to an insufficient number of animals.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report Date:
1985

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
- only one animal was used; due to the pyrophoric nature of the test material, the test was discontinued.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid (unspecified)
Details on test material:
- Appearance: Colourless liquid
- Storage conditions of test material: Room temperature - air tight

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Age at study initiation: Young adult
- Housing: Individually housed
- Diet: ad libitum
- Water: municipal water was supplied via an automatic watering system ad libitum
- Acclimation period: 15 days

ENVIRONMENTAL CONDITIONS
- Temperature: 60 to 70 °F
- Humidity: 30-70 %
- Photoperiod: 12 hour light/dark cycle

IN-LIFE DATES: From: 11 March 1985 To: 29 March 1985

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The contralateral eye served as the control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
Duration of treatment / exposure:
A single administration was made into the conjunctival sac of the eye
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
1
Details on study design:
EVALUATION OF OCULAR IRRITATION
INTERVALS: Approximately 24, 48 and 72 hours after treatment
SCORING SYSTEM: Draize Scale
TOOL USED TO ASSESS SCORE: The presence or absence of ulceration was confirmed with fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #1
Time point:
other: Mean of 24, 48 and 72 hour observations
Score:
0
Max. score:
3
Reversibility:
other: not applicable
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: Mean of 24, 48 and 72 hour observations
Score:
1
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: The study was terminated before the eye had fully recovered.
Irritation parameter:
other: discharge
Basis:
animal #1
Time point:
other: Mean of 24, 48 and 72 hour observations
Score:
0.67
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Irritant / corrosive response data:
Mild, transient ocular irritation consisting primarily of conjunctival chemosis and discharge with the most severe effects noted at 24 hours was observed. No corneal changes were seen.
Other effects:
Upon administration of the test material, any material on the eyelids or hair around the eyes ignited. The fire was extinguished with pressure from paper towels. Based on this, the test material was considered to be too reactive and no further animals were dosed.
Periorbital erythema and chemosis apparently resulting from this ignition of the periorbital hair at the time of dosing were noted. This was still evident after 72 hours.

Applicant's summary and conclusion

Interpretation of results:
other: Inconclusive
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
The irritancy potential of the test material cannot be concluded from this study due to the use of a single animal. The study was terminated after administration to the first animal due to the pyrophoric properties of the substance.
Executive summary:

The eye irritation potential of the test material to the New Zealand White rabbit was investigated in a study conducted using methodology similar to the standardised guideline OECD 405.

The undiluted test material was administered at a dose of 0.1 mL to the conjunctival sac of the eye in the first of six animals. Upon administration of the test material, any material on the eyelids or hair around the eyes ignited. The fire was extinguished with pressure from paper towels. Based on this, the test material was considered to be too reactive and no further animals were dosed. The single female rabbit administered with the test material was observed for 72 hours for signs of irritation.

Mild, transient ocular irritation consisting primarily of conjunctival chemosis and discharge with the most severe effects noted at 24 hours was observed. No corneal changes were seen.

Periorbital erythema and chemosis apparently resulting from the ignition of the periorbital hair at the time of dosing were noted. This was still evident after 72 hours.

The irritancy potential of the test material cannot be concluded from this study due to the use of a single animal. The study was terminated after administration to the first animal due to the pyrophoric properties of the substance.