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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:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: guideline study, GLP, full report available. Also assessed by OECD.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report Date:
1990

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Specific details on test material used for the study:
- Physical state: yellowish, solid
- Analytical purity: 99.7%
- Purity test date: 10 jan 1989

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Breeder Interfauna UK, Ltd. Wyton, Huntington, England
- Weight at study initiation: 300-340 g
- Housing: Indiviudally housed in stainless stell cages or polyethylene cages.
- Diet (e.g. ad libitum): Standard diet Ssniff K 4 approx 100-120 g/animal/day; once per day in the morning.
- Water (e.g. ad libitum): Tap water
- Acclimation period: Prior to the initiation of treatment the animals were kept for at least 14 days in the quarantine station and monitored.


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3 deg C
- Humidity (%): approx 50%
- Air changes (per hr): 10 times per hour
- Photoperiod (hrs dark / hrs light):12 hours, artificial illumination from 6 to 18hrs CET

Test system

Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
Concentration: 99.7 %
Amount applied: 70 other: mg
Duration of treatment / exposure:
24 hour
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): 24 hrs after instillation of the test substance, treated eye was rinsed with saline

SCORING SYSTEM: DRAIZE


TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 1, 24, 48, 72hrs and 7 days
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 1, 24, 48, 72hrs and 7d
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 1, 24, 48, 72hrs and 7d
Score:
0.3
Max. score:
0.3
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 1, 24, 48, 72hrs, 7d
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 1, 24, 48, 72hrs, 7d
Score:
0
Max. score:
0
Irritant / corrosive response data:
There was mild reactions of the mucous membranes and the cornea but is considered as mechanically induced.

Any other information on results incl. tables

CORNEA: no findings
IRIS: no findings
CONJUNCTIVA: slight rednes(3/3; 1-24 h), slight swelling (1/3; 1 h), discharge (3/3; 1 h)

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
not irritating
Executive summary:

The irritant/corrosive effects of test substance Disflamoll TP were tested on the eyes of rabbits in accordance with OECD Guideline 405. Interpretation was based on the nature, intensity and reversibility of the responses. In this study, the test substance was not irritating to the eyes of rabbits following an exposure period of 24 hours. Mild reactions of the mucous membranes and the cornea immediately following exposure but is considered to be mechanically induced effects.