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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:
supporting study
Study period:
9th September 1985 to 16th September 1985
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Study is conducted by recognised test house, to experimental procedure in compliance with OECD Guideline 402 and Annex V of the 6th Amendment of the EEC Directive 79/831/EEC - Part B: Methods for the determination of toxicity B5 Eye Irritation. Full data set and rationale provided. GLP compliance not specified, although report is subject to Quality Assurance Procedure.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report Date:
1985

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
and method B5, Annex V 79/831/EEC
Deviations:
no
GLP compliance:
not specified
Remarks:
No mention of GLP is made within the report; however the report was subject to Quality Assurance at the laboratory where the testing was conducted. As such, it is assumed that the principles of GLP were followed

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Bontron E-84
- Substance type: Solid
- Physical state: White powder
- Analytical purity: Not specified
- Impurities (identity and concentrations): Not specified
- Lot/batch No.: No batch number is specified within the report, but the test substance is deemed equivalent based on history of manufacture and use.
- Stability under test conditions: Not determined
- Storage condition of test material: Ambient temperatures

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Froxfield Rabbits, Petersfield, Hampshire, England
- Age at study initiation: Approximately 9 to 11 weeks
- Weight at study initiation: 2.0 to 2.3 kg
- Housing: individually housed in metal cages with perforated floors
- Diet (e.g. ad libitum): SDS Standard Rabbit diet, ad libitum
- Water (e.g. ad libitum): Tap water, ad libitum
- Acclimation period: Timescale unspecified, although report details that rabbits selected for the study were all acclimated to the laboratory environment.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 °C
- Humidity (%): 30 - 70 %
- Air changes (per hr): Approximately 19 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours of artificial light (0700-1900 hours) in each 24 hour period


IN-LIFE DATES: From: 9th September 1985 To: 16th September 1985

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 65mg portion of the sample as supplied, occupying a volume of 0.1ml placed into the lower everted lid of one eye of each animal under test.
- Concentration (if solution): N/A – applied as supplied.

VEHICLE
- Amount(s) applied (volume or weight with unit): N/A – applied as supplied.
- Concentration (if solution): N/A – applied as supplied.
- Lot/batch no. (if required): N/A – applied as supplied.
- Purity: N/A – applied as supplied.
Duration of treatment / exposure:
7 days
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): Not applicable; test material not removed.
- Time after start of exposure: Not applicable.


SCORING SYSTEM:
Examination of the eyes was made after 1 hour and 1,2,3,4 and 7 days after instillation. Grading and scoring of the ocular lesions were performed using the recognised scoring system as follows:

Cornea: degree of density (area most dense taken for reading)

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

Iris

Normal: 0
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): 1
No reaction to light, haemorrhage, gross destruction (any or all of these): 2

Conjunctivae:

Redness (refers to palpebral and bulbar conjunctivae cornea and iris)
Blood vessels normal: 0
Some blood vessels definitely hyperaemic (injected): 1
Diffuse, crimson colour, individual vessels not easily discernible: 2
Diffuse, beefy red: 3

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

Other lesions not described by the above scoring system where also to be described.


TOOL USED TO ASSESS SCORE: Hand held torch

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
animal #1
Remarks:
Redness noted
Time point:
other: 1 hour
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 24 hours
Remarks on result:
other: Very slight transient conjunctival reactions were observed at the one hour stage only.
Irritation parameter:
conjunctivae score
Basis:
animal #2
Remarks:
Redness noted
Time point:
other: 1 hour
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 24 hours
Remarks on result:
other: Very slight transient conjunctival reactions were observed at the one hour stage only.
Irritation parameter:
conjunctivae score
Basis:
animal #3
Remarks:
Redness noted
Time point:
other: 1 hour
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 24 hours
Remarks on result:
other: Very slight transient conjunctival reactions were observed at the one hour stage only.
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 7 days
Score:
0
Max. score:
0
Remarks on result:
other: No effects noted in any animal
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 7 days
Score:
0
Max. score:
0
Remarks on result:
other: No effects noted in any animal
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 7 days
Score:
0
Max. score:
0
Remarks on result:
other: No effects noted in any animal
Irritant / corrosive response data:
None of the animals gave a "positive" reaction.
No corneal damage or iridial inflammation was seen in any of the animal throughout the seven day observation period.
Very slight transient conjunctival reactions were observed at the one hour stage only. Effects were no longer present at 24 hours.
Other effects:
None

Any other information on results incl. tables

Rabbit no and Sex

Region of the Eye

One hour

Day after installation

Result

Positive (+)

Negative (-)

556F

Cornea

0

1

2

3

4

7

-

Iris

0

0

0

0

0

0

Conjunctivae

Redness

1

0

0

0

0

0

Chemosis

0

0

0

0

0

0

557M

Cornea

0

0

0

0

0

0

-

Iris

0

0

0

0

0

0

Conjunctivae

Redness

1

0

0

0

0

0

Chemosis

0

0

0

0

0

0

570F

Cornea

0

0

0

0

0

0

-

Iris

0

0

0

0

0

0

Conjunctivae

Redness

1

0

0

0

0

0

Chemosis

0

0

0

0

0

0

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the expermimental study data, the substance is not deemed to be classified as an irritant to the eye. No associated risk phrase is therefore appropriate.
Executive summary:

The ocular irritation of the test substance was assessed using three New Zealand White rabbits. Minimal conjunctival reactions were noted in each animal that was reversible within 24 hours of exposure. Based on the study data, the substance is considered to be non-irritant to the eye.