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:
1986
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Well documented, according to accepted guidelines.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report Date:
1986

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
-reliability scoring based on 2002 guideline
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Secondary Butyl Alcohol
- Physical state: colourless, clear liquid
- Analytical purity: 99.5%
- Expiration date of the lot/batch: one calendar month from the date of issue
- Lot/batch No.: Indent 9200/9530
- Stability under test conditions: Test substance was judged to have been stable for the duration of this study.
- Storage condition of test material: Following its arrival in compound control this test substance was stored in the dark at ambient temperature.

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Sittingbourne Research Centre breeding colony
- Age at study initiation: 4 to 9 months old
- Weight at study initiation: 3850 to 4292 g (males) and 4775 to 4920 g (females)
- Housing: Housed individually
- Diet (e.g. ad libitum): Food (standard rabbit diet, S.Q.C., Special Diet Services Ltd., Essex), ad libitum
- Water (e.g. ad libitum): Filtered but untreated water from the public supply (whether or not water was administered ad libitum was not reported).
- Acclimation period: 2 weeks

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16 to 19 °C
- Humidity (%): not reported
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL

Duration of treatment / exposure:
Single exposure
Observation period (in vivo):
14 days
Number of animals or in vitro replicates:
3 animals/sex
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The eyes were not washed.
- Time after start of exposure: Not applicable.


SCORING SYSTEM: Same scale as the one provided in the OECD guideline, with the exception of 1 criteria (changes related to discharge were included in addition to the other parameters evaluated).

Discharge:
No discharge = 0
Any amount different from normal = 1
Discharge with moistening of lids and hairs adjacent to lids = 2
Discharge with moistening of llds and hairs and considerable area around eye = 3

The degree of irritation was classified using the following scheme which is based on the OECD Data Interpretation Guides (1984).

- No irritation - Exposure of the eye to the material under the specified conditions causes no significant ocular changes. No tissue staining with fluorescein is observed. Any changes that occur, clear within twenty-four hours.

- Irritation - Exposure of the eye to the material under the specified conditions causes minor, superficial, and transient changes of the cornea, iris, or conjunctiva as determined by external or silt-lamp examination with fluorescein staining. The appearance at any grading interval of any of the following changes is sufficient to characterize a response as irritation: opacity of the cornea (other than a slight dulling of the normal luster), hyperemia of the iris, or swelling of the conjunctivae. Any changes that are seen clear within seven days.

- Substantial irritation - Exposure of the eye to the material under the specified conditions causes significant injury to the eye, such as loss of the corneal epithelium, corneal opacity, iris (other than a slight injection), conjunctivitis, pannus, or bullae. The effects heal or clear within twenty-one days.

- Corrosion - Exposure of the eye to the material under the specified conditions results in significant tissue destruction (necrosis). Injuries persist or are expected to persist for twenty-one days or more.

The above classification is based on the most severe responses which are seen in any one animal of a treated group receiving the same test substance and treatment.

TOOL USED TO ASSESS SCORE: One drop of 2% fluorescein solution

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48, and 72 hours
Score:
0.5
Max. score:
4
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: See attached table for individual results
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48, and 72 hrs
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 hrs
Remarks on result:
other: See attached table for individual results
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48, and 72 hrs
Score:
0.2
Max. score:
2
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: See attached table for individual results
Irritation parameter:
other: redness
Basis:
mean
Time point:
other: 24, 48, and 72 hrs
Score:
1.5
Max. score:
3
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: See attached table for individual results
Irritant / corrosive response data:
The instillation of undiluted secondary butyl alcohol into the conJunctival sac of one eye of each of six rabbits resulted in moderate initial pain. All rabbits had moderate conjunctival inflammation with some discharge, within 1 h of dosing. The swelling and discharge had largely cleared by 4 hours but the redness persisted in three rabbits at 7 days. These animals and one other animal had impaired iritic response and/or slight corneal opacity between 24 and 72 hours post-dosing. The effects had cleared by 7 days in all rabbits except for 1 animal. As this animal’s eye was intensely opaque over the entire cornea and there was no iritic response it was killed for humane reasons; recovery was not considered possible. The remaining rabbits were retained, and by 14 days, all ocular effects had cleared. Considering the fact that in 5/6 animals only mild, reversible, irritation (insufficient to classify) was observed, it seems to be an idiosyncratic animal. It is unclear from this study whether the lack of reversibility is directly related to the test material.

Applicant's summary and conclusion

Interpretation of results:
Category II
Remarks:
Migrated information Causes serious eye damage Criteria used for interpretation of results: other: CLP (EC 1272/2008)