Registration Dossier

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
Study period:
From 1992-07-27 to 1992-07-31
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
GLP study in accordance with recognised test guideline but: Lot/batch No.: not stated Expiration date of the lot/batch: not stated NOTE: study deemed acceptable because spectral data for test item are available, covering approximately before and after the test period - see section 1.4 Analytical Information.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report Date:
1992

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
1987
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Version / remarks:
1984
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
Purity: Ca. 100%

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Rosemead Rabbits, Rosemead, Waltham Abbey, Essex, England
- Age at study initiation: 4 - 4 1/2 months
- Weight at study initiation: 3.31 - 3.52 kg
- Housing: Individually in suspended stainless steel cages (Type RC10/L/TR6) monted in mobile batteries (Modular Sysytems and Development Company Limited, London, England). The cages measured 61 x 76 x 46 cm high and were fitted with perforayed countersunk floor panels. A tray beneath the floor was lined with absorbent paper which was changed regularly.
- Diet (e.g. ad libitum): Animals had free access to food hoppers containing standard pelleted rabbit diet, (S.Q.C. Rabbit Diet - Special Diets Services
Limited, Witham, Essex, England). The manufacturer supplied analytical data with each batch of diet supplied. This included the concentration of nutritional components, aflatoxins and selected heavy metals, pesticides and micro-organisms. The diet contains no added antibiotic or other chemotherapeutic or prophylactic treatment.
- Water (e.g. ad libitum): The rabbits had free access to tap water taken from the public supply
- Acclimation period: Three weeks.


ENVIRONMENTAL CONDITIONS
- Temperature (°C): Target value 18ºC, actual range 15ºC to 23ºC
- Humidity (%): Target value 55% RH, actual range 40% - 70% RH
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 / 12


IN-LIFE DATES: From: 27 July 1992 To 31 July 1992

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
100 mg of unchanged substance was instilled into the right eye.
Duration of treatment / exposure:
Indeterminate
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3 animals were used in this study
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): No


SCORING SYSTEM: Darize
Refer to Attached Background Information for details of the scoring system used.

TOOL USED TO ASSESS SCORE: Ophthalmoscope

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
other: for all three animal tested
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
other: for all three animal tested
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
>= 0.3 - <= 0.7
Max. score:
2
Reversibility:
fully reversible within: 72h
Remarks on result:
other: for all three animal tested
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
1
Reversibility:
not fully reversible within: 24h
Remarks on result:
other: for all three animal tested
Irritant / corrosive response data:
A crimson-red conjunctival appearance, very slight chemosis and very slight discharge were observed in all animals one hour after instillation of test item. Injection of the conjunctival blood vessels persisted up to the 48 hour observation.
The eyes of all rabbits were overtly normal by the 72 hour examination.
Other effects:
Instillation of the test material caused a very slight or slight initial pain response.

Any other information on results incl. tables

Individual scores:

Animal No.

cornea opacity

iris

conjunctivae

chemosis

1h

24h

48h

72h

1h

24h

48h

72h

1h

24h

48h

72h

1h

24h

48h

72h

27TK333M

0

0

0

0

0

0

0

0

2

1

1

0

1

0

0

0

27TK336M

0

0

0

0

0

0

0

0

2

1

0

0

1

0

0

0

27TK337M

0

0

0

0

0

0

0

0

2

1

1

0

1

0

0

0

Applicant's summary and conclusion

Interpretation of results:
other: not irritating
Conclusions:
Under the conditions of the test, the test item was classified as 'non-irritant' to the eye.
Executive summary:

The potential of test item to cause damage to the conjunctiva, iris or cornea was assessed in three New Zealand White rabbits, each subject to single ocular instillation of 100 mg of the test material according to OECD 405. Ocular reactions were examined 1, 24, 48 and 72 hours after treatment. Crimson-red conjunctival appearance and very slight chemosis and discharge were observed in all animals one hour after instillation. Injection of the conjunctival blood vessels persisted up to the 48 hour observation. The eyes of all rabbits were overtly normal by the 72 hour examination. Instillation of the test material caused a very slight or slight initial pain response. Under the conditions of this test, the test item was classified as 'non-irritant' to the eye.