Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
July 24-27, 2001
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study is performed in accordance with OECD guideline 404 (1987) and meets the requirements of GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report Date:
2001

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Physical state: dark blue powder
- Stability under test conditions: expected to be stable

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Davidson's Mill Farm, South Brunswick, NJ, USA
- Age at study initiation: young adult
- Weight at study initiation:
- Housing: singly housed
- Diet (e.g. ad libitum): Pelleted Purina Rabbit Chow #5326
- Water (e.g. ad libitum):Filtered tap water ad libitum
- Acclimation period: 6 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-22
- Humidity (%):
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: To:

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: other eye of each rabbit remained untreated and served as the reference control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml (approx. 0.06-0.07 gr) of ground test substance
- Concentration (if solution):


VEHICLE
- Amount(s) applied (volume or weight with unit):
- Concentration (if solution):
- Lot/batch no. (if required):
- Purity:
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3 (2 male and 1 female)
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done):

SCORING SYSTEM: Draize (high-intensity white light)

TOOL USED TO ASSESS SCORE: fluorescein (the fluorescein dye evaluation procedure was used at 24 hours and as needed at subsequent scoring intervals to evaluate the extent of corneal damage or to verify reversal of effects).

Results and discussion

In vivo

Results
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
other: 1 hour
Score:
6
Max. score:
6
Reversibility:
fully reversible within: 48 hours
Irritant / corrosive response data:
MMTS of all 3 animals after 1 h =6
MMTS after 24 hours of animal 1 = 5, animal 2 = 2 and animal 3 = 4
MMTS of all 3 animals ater 48 and 72h = 0

Any other information on results incl. tables

One hour after test substance installation, all three treated eyes exhibited conjunctivitis. By 24 hours, corneal opacity was evident in one treated eye and conjunctivitis pesisted in two rabbits.

Based on the scheme for classifying eye irritants by Kay and Calandra (Interpretation of eye irritation tests. J. Soc. Cos. Chem. 1962; 13:281-289), the test substance is classified as minimally irritating to the eye.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of this study, the test substance is not irritating to the eye.