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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
1996/02/14 - 1996/03/04
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to the appropriate OECD test guideline, and in compliance with GLP. The study is considered Reliability 1. The read-across is considered Reliability 2.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report Date:
1996

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
Details on test material:
- Name of test material (as cited in study report): Kalcol 0898

- Substance type: alcohol

- Physical state: a clear colourless liquid

- Storage condition of test material: ambient temperature, in the original container.

- Other: The identity, strength and purity of the test material were the responsibility of the sponsor.

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS

- Source: Froxield SPF Rabbits, Broadway Farm, Froxfield, Hampshire, England.

- Age at study initiation: ca. 5 months old

- Weight at study initiation: 2.88-3.12kg

- Housing: Stainless steel cages mounted in mobile batteries. The cages were fitted with perforated countersunk floor panels, with a tray beneath the floor lined with absorbent paper which was changed at regular intervals.

- Diet: STANRAB (P) SQC Standard pelleted rabbit diet (ad libitum), Special Diets Services Ltd., Witham, Essex, England.

- Water: Public supply (ad libitum)

- Acclimation period: The report states that the animals were acclimatized but does not state duration.


ENVIRONMENTAL CONDITIONS

- Temperature (°C): 18C (range 15-23C)

- Humidity (%): 55% (40-70%)

- Air changes (per hr): 10

- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: To:

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The other eye of each animal served as a control.
Amount / concentration applied:
TEST MATERIAL

- Amount(s) applied (volume or weight with unit): 0.1ml, undiluted


Duration of treatment / exposure:
The animals were subjected to a single ocular instillation of the test material. Ocular reactions were assessed at 1, 24, 48 and 72 hours after treatment and on days 8, 15 and 22.
Observation period (in vivo):
The behaviour of each rabbit was observed for several minutes immediately following instillation of the test material. The animals were returned to their cages and checked at least twice during the first hour after dosing, at regular intervals throughout the day. Ocular reactions were assessed 1, 24, 48 and 72 hours after treatment. Additional observations were made on says 8, 15 and 22.
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE

- Washing (if done): Not rinsed.


SCORING SYSTEM: As prescribed in OECD test method.


TOOL USED TO ASSESS SCORE: An opthalmoscope or pencil beam torch was used to facilitate inspection of the eyes. From the 24 hour examination onwards, fluorescein was used, if necessary, to aid the examination of the cornea.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24/48/72h
Score:
1.3
Max. score:
2
Reversibility:
not fully reversible within: 72h
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24/48/72h
Score:
1
Max. score:
1
Reversibility:
not fully reversible within: 22 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24/48/72h
Score:
1
Max. score:
3
Reversibility:
not fully reversible within: 22 days
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24/48/72h
Score:
1.8
Max. score:
2
Irritant / corrosive response data:
Iritis, slight to moderate conjuncitivitis and areas of very slight/slight corneal opacity during the first 72 hours. Very slight conjunctivitis observed in all 3 animals at days 8 and 15. Very slight conjunctivitis persisted in 2 animals until termination on day 22. Iritis persisted in one of these rabbits until day  22. 
Other effects:
Blepharitis of the lower lid seen in 2 rabbits at 72 hours persisting to day 8 in one rabbit. Very slight/slight initial pain response.

Any other information on results incl. tables

 Table 1: Irritant/corrosive response data for each animal at each observation time up to removal of each animalfrom the test

Score at time point / Reversibility

Cornea

Iris

Conjunctivae

Chemosis

Max. score: 4

Max. score: 2

Max. score: 3

Max. score: 4

60 min

2/1/1

1/ 1/1

2/ 2/2

2/2/2

24 h

 2/1/1

 1/1/1

 2/2/2

 1/1/1

48 h

 2/1/1

 1/1/1

 2/2/1

 1/2/0

72 h

 2/1/1

 1/1/1

 3/1/1

 1/1/1

Average 24h, 48h, 72h

 2/1/1

1/1/1 

2.3/1.7/1.3 

1/1.3/0.7

Reversibility*)

 nc

nc 

nc 

Average time (unit) for reversion

 72 hours

Day 22 

Day 22 

-

 

*) Reversibility: c. = completely reversible;n.c. = not completely reversible; n. = not reversible

 

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Kalcol 0898 is an eye irritant according to EU criteria based on individual mean 24+48+72 hour scores for iritis of >= 1 in all test animals. This material is considered an eye irritant under GHS and to cause a risk of serious damage to eyes (EU) based on persistence of iritis (1 rabbit) and conjunctivitis (2 rabbits) to 22 days.
Classification: risk of serious damage to eyes.