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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
Study period:
1978
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
The study was performed according to a method similar to OECD 405 and pre-GLP. There is no data on substance indentity or composition. Since observed effects are minor and all other effects were reversible within 7 days it is assumed that the redness will also be reversibel within 21 days.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report Date:
1978

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Qualifier:
according to
Guideline:
other: U.S. FDA (Fed. Reg. 28(119), 5582, 1963)
Principles of method if other than guideline:
The study did not last for 21 days to study reversibility but this would also not be acceptable nowadays for animal welfare reasons.
GLP compliance:
no
Remarks:
pre-GLP

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
solid: crystalline
Details on test material:
Name: Ketjenflex 9R
Appearance: a white solid
Date received: 15 March 1978

The test article, identified by trade name in the report, was chemically identified by contemporaneous documents (i.e. MSDS, memos, product bulletins etc.) as o/m/p-TSA, with 40/10/50 ratio.

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: no data
- Age at study initiation: no data
- Weight at study initiation: no data
- Housing: no data
- Diet (e.g. ad libitum): no data
- Water (e.g. ad libitum): no data
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data

IN-LIFE DATES: no data

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye served as the control
Amount / concentration applied:
0.1g
Duration of treatment / exposure:
One single dose is given
Observation period (in vivo):
The eyes are examined at 24, 48, 72 hours and 7 days after instillation of the test material.
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): not done
- Time after start of exposure: not applicable

SCORING SYSTEM: Scoring system eye irritation

Cornea: degree of density (area most dense taken for reading)
0 No ulceration or opacity
1 Scattered or diffuse areas of opacity (other than slight dulling of normal lustre), details of iris clearly visible
2 Easily discernible translucent areas, details of iris slightly obscured
3 Nacrous areas, no details of iris visible, size of pupil barely discernible
4 Opaque cornea, iris not discernible through the opacity

Iris
0 Normal
1 Markedly deepened rugae, congestion, swelling, moderate circumcorneal hyperaemia or injection, any of these or combination of any thereof, iris still reacting to light (sluggish reaction is positive)
2 No reaction to light, haemorrhage, gross destruction (any or all of these)

Conjunctivae
Redness (refers to palpebral and bulbar conjunctivae cornea and iris)

0 Blood vessels normal
1 Some blood vessels definitely hyperaemic
(injected)
2 Diffuse, crimson colour, individual vessels not easily discernible
3 Diffuse, beefy red

Chemosis (lids and/or nictitating membranes)
0 No swelling 0
1 Any swelling above normal (includes nictitating membranes)
2 Obvious swelling with partial eversion of lids
3 Swelling with lids about half-closed
4 Swelling with lids more than half-closed

TOOL USED TO ASSESS SCORE: Ocular reactions are read using a binocular magnifying glass. The diagnosis of corneal damage is confirmed, if necessary, by staining the eyes of the animals with fluorescein-impregnated papers. After flushing the excess fluorescein solution, the eyes are examined in a dark room under ultraviolet illumination.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
all animals
Time point:
other: 14-48-72h
Score:
0.1
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24-48-72 h
Score:
0.05
Max. score:
2
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24-48-72h
Score:
1.05
Max. score:
3
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: A score of 1 remained in 3 out of 6 animals after 7 days. In the other 3 animals effects were reversible.
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24-48-72h
Score:
0.4
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritant / corrosive response data:
Very slight corneal damage, slight iritis and moderate lesions of the conjunctivae in one out of six rabbits and slight lesions of the conjunctivae in the other five rabbits.

Any other information on results incl. tables

Rabbit No and sex

Region of the eye

Hours after instillation

Average 24-48-72 hours

24

48

72

7 days

13

Cornea

Degree of opacity

0

0

0

0

0

Iris

0

0

0

0

0

Conjunctivae

Redness

1

1

1

1

1

Chemosis

1

1

0

0

0.6

14

Cornea

Degree of opacity

0

0

0

0

0

Iris

0

0

0

0

0

Conjunctivae

Redness

1

1

1

0

1

Chemosis

1

0

0

0

0.3

15

Cornea

Degree of opacity

0

0

0

0

0

Iris

0

0

0

0

0

Conjunctivae

Redness

1

1

0

0

0.6

Chemosis

1

0

0

0

0.3

16

Cornea

Degree of opacity

0

0

0

0

0

Iris

0

0

0

0

0

Conjunctivae

Redness

1

1

1

1

1

Chemosis

1

0

0

0

0.3

17

Cornea

Degree of opacity

1

1

0

0

0.6

Iris

1

0

0

0

0.3

Conjunctivae

Redness

2

1

1

1

1.7

Chemosis

2

1

0

0

3

18

Cornea

Degree of opacity

0

0

0

0

0

Iris

0

0

0

0

0

Conjunctivae

Redness

1

1

1

0

1

Chemosis

1

1

0

0

0.6

Applicant's summary and conclusion

Conclusions:
The test substance is not considered as eye irritant according to GHS. The animals were not observed for 21 days and not all effects had dissappeared within 7 days. A score of 1 for redness remained in 3 out of 6 animals after 7 days. In the other 3 animals effects were reversible. Since observed effects are minor and all other effects were reversible within 7 days it is assumed that the redness will also be reversibel within 21 days.
Executive summary:

A study was performed to access the eye irritancy of Ketjenflex 9R. The study was performed pre-GLP. The study is similar to OECD405. 0.1g of the test substance was instilled in the eye of one rabbit. The untreated eye served a sthe control. Observations were made after 24, 48, 72 hours and after 7 days. In these animals very slight corneal damage, slight iritis and moderate lesions of the conjunctivae in one out of six rabbits and slight lesions of the conjunctivae in the other five rabbits. The test substance is not considered as eye irritant according to GHS. The animals were not observed for 21 days and not all effects had dissappeared within 7 days. A score of 1 for redness remained in 3 out of 6 animals after 7 days. In the other 3 animals effects were reversible. Since observed effects are minor and all other effects were reversible within 7 days it is assumed that the redness will also be reversibel within 21 days. Besides, the score of 1 was not considered sufficient as positive reation according to the protocol.