Registration Dossier

Diss Factsheets

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:
1990
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP-study according to OECD guideline 405.

Data source

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

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Constituent 1
Details on test material:
- Name of test material (as cited in study report): T-4388
- Physical state: Colorless liquid
- Lot/batch No.: 6
- Storage condition of test material: Stored i the dark under ambient conditions

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Cheshire Rabbit Farms Limited,Duddon Lodge, Tarporley,Cheshire
- Housing: The rabbits were housed individually in aluminum cages with grid floors beneath which were peat moss filled trays
- Water (. ad libitum): Tap water
- Acclimation period:7 days
- Feed: (. ad libitum) Standard rabbit diet, supplied by Special Diets Services, 1 Stepfield, Witham, Essex, CMB 3AD

ENVIRONMENTAL CONDITIONS
- Temperature (°C): Mean environmental maximum and minimum temperatures were both 17°C
- Humidity (%): Mean relative humidity was 51%
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12 hrs dark / 12 hrs light


IN-LIFE DATES: From: 1990-04-04 To: 1990- 04-09

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
Amount: 0.1ml
Concentration - 100 %



Duration of treatment / exposure:
Single application
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): No


SCORING SYSTEM: See other information on materials and methods


TOOL USED TO ASSESS SCORE: 420/5.5× Panoramic Loupe ( Keeler, U. K. ) and Pen torch (Pifco )

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
0
Reversibility:
other: No effects observed
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
0
Reversibility:
other: No effects observed
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
0
Reversibility:
other: No effects observed
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
Over all animals
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
0
Reversibility:
other: No effects observed
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
0
Reversibility:
other: No effects observed
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
0
Reversibility:
other: No effects observed
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
0
Reversibility:
other: No effects observed
Irritation parameter:
iris score
Basis:
mean
Remarks:
Over all animals
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
0
Reversibility:
other: No effects observed
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
0
Reversibility:
other: No effects observed
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
0
Reversibility:
other: No effects observed
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
0
Reversibility:
other: No effects observed
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
Over all animals
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
0
Reversibility:
other: No effects observed
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
0
Reversibility:
other: No effects observed
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
0
Reversibility:
other: No effects observed
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
0
Reversibility:
other: No effects observed
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
Over all animals
Time point:
other: 24, 48 and72 hours
Score:
0
Max. score:
0
Reversibility:
other: No effects observed
Irritant / corrosive response data:
Slight conjunctival redness, slight chemosis and a slight discharge were noted in 1 h post instillation. All responses were reversible by 24 h. No corneal and iridial responses were noted.
Other effects:
No signs of systemic intoxication were observed

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the results of this study T-4388 is not irritanting to rabbit eyes. As per EU classification this test material does not need be classified.
Executive summary:

The eye irritation potential of a test material, T-4388 (Colorless liquid) was investigated in New Zealand White rabbits. Two male and one female nulliparous and non-pregnant young adult New Zealand white rabbits were used , which were supplied by Cheshire Rabbit Farms Limited,Duddon Lodge, Tarporley,Cheshire.

                                                                                                                

The rabbits were housed individually in aluminum cages with grid floors beneath which were peat moss filled trays. The rabbits were allowed an acclimatization period of 7 days. Mean environmental maximum and minimum temperatures were both 17°C maintained in rabbit rooms with relative humidity 51% and photoperiod of 12 hrs dark / 12 hrs light.

The rabbit was held firmly but gently and the test material 0.1 ml placed into right eye by gently pulling the lower eyelid away from the eyeball to form a sac into which test material was dropped. The lids were then gently held together for one or two seconds and observed up to 48 hours after instillation for signs of severe irritation. As none were noted, remaining 2 rabbits were treated. The other eye rabbit served as a control. The eyes were examined for irritation by using 420/5.5× Panoramic Loupe ( Keeler, U. K. ) and Pen torch (Pifco ) and ocular reactions were recorded 1, 24, 48, 72 hour after instillation.

Slight conjunctival redness, slight chemosis and a slight discharge were noted in 1 h post instillation. All responses were reversible by 24 h. No corneal and iridial responses were noted.

Based on the results of this study T-4388 is slightly irritating to rabbit eyes but this is quickly reversible. As per EU classification this test material is practically non irritating when tested on rabbit eyes.

Categories Display