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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:
20 December 1993 to 18th January 1994
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline and GLP compliant study
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report date:
1994

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Principles of method if other than guideline:
Not relevant
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Octanal
EC Number:
204-683-8
EC Name:
Octanal
Cas Number:
124-13-0
Molecular formula:
C8H16O
IUPAC Name:
octanal
Constituent 2
Reference substance name:
Aldehyde C8
IUPAC Name:
Aldehyde C8
Test material form:
other: clear liquid
Details on test material:
- Name of test material (as cited in study report): Aldehyde C8

- Physical state: Clear liquid
- Analytical purity: 99%
- Lot/batch No.: 93/09/20
- Expiration date of the lot/batch: March 1994
- Storage condition of test material: Room temperature in the dark.

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Froxfield (U .K.) Ltd., Petersfield, Hampshire, England.
- Age at study initiation: 13 to 15 weeks of age
- Weight at study initiation: 2.9 to 3.6 kg
- Housing: Housed individually in plastic cages with perforated floors.
- Diet (e.g. ad libitum): Standard laboratory diet SDS Stanrab (P) Rabbit Diet ad libitum
- Water (e.g. ad libitum): Drinking water ad libitum
- Acclimation period: The rabbits were acclimatised but the period of acclimatisation is not specified in the study report.

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

IN-LIFE DATES: From: 20 December 1993 To: 18 January 1994

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the untreated contralateral eye
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume): 0.1ml

Duration of treatment / exposure:
14 days
Observation period (in vivo):
14 days.
All animals were observed daily for signs of ill health or toxicity. Examination of the eyes was made after 1 hour and 1, 2, 3 (equivalent to 24, 48 and 72 hours after instillation), 4, 7 and 14 days after instillation.
Number of animals or in vitro replicates:
3 animals
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): No information provided to indicate treated eyes were rinsed after instillation

SCORING SYSTEM: Modified Draize assessment
Cornea :
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 transIucent areas, details of iris slightly obscured 2
Nacreous 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 the most severe reading of palpebral and bulbar conjunctivae, as compared to the control eye)
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 nictating membranes)
No swelling 0
Any swelling above normal (includes nictating membranes) 1
Obvious swelling with partial eversion of lids 2
Swelling with lids about half-closed 3
Swelling with lids more than half-closed 4

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: Dulling of the cornea was observed one hour after administration
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24 h
Score:
0
Max. score:
2
Reversibility:
not specified
Remarks on result:
other: No effects observed on the iris
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #1
Time point:
24 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24 h
Score:
ca. 1.6
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: Dulling of the corneas was observed 1 hour after administration
Irritation parameter:
iris score
Basis:
animal #2
Time point:
72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #2
Time point:
72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 14 days
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: Dulling of the cornea was observed one hour after administration
Irritation parameter:
iris score
Basis:
animal #3
Time point:
72 h
Score:
0
Max. score:
2
Reversibility:
not specified
Remarks on result:
other: No effects observed on the iris
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #3
Time point:
72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 14 days
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0.67
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0.22
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
2.11
Max. score:
3
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
1.89
Max. score:
4
Irritant / corrosive response data:
Corneal opacities developed in two animals. Dulling of the normal lustre of the cornea was seen in one animal. Iridial inflammation was observed in one animal.
A diffuse crimson colouration of the conjunctivae was seen in all three animals and was accompanied by swelling with partial eversion of the eyelids or with the eyelids about half closed. The eyes had returned to normal 7 or 14 days after instillation
Other effects:
There were no signs of toxicity or ill health in any rabbit during the observation period.

Any other information on results incl. tables

Ocular Reactions observed after instillation of Aldehyde C8:

Rabbit

Region of the eye

One hour

Day after instillation

 

1

2

3

4

7

14

1*

Cornea

D

0

0

0

0

0

 

Iris

0

0

0

0

0

0

 

Conjunctivae

Redness

2

2

2

2

1

0

 

Chemosis

3

2

1

1

1

0

 

2

Cornea

D

1

1

1

1

1

0

Iris

0

1

0

1

1

0

0

Conjunctivae

Redness

2

3

2

2

2

2

0

Chemosis

3

3

2

2

1

1

0

3

Cornea

D

1

1

1

1

0

0

Iris

0

0

0

0

0

0

0

Conjunctivae

Redness

2

2

2

2

2

2

0

Chemosis

3

2

2

2

2

1

0

* Pilot Animal

D Dulling

Applicant's summary and conclusion

Interpretation of results:
Category 2A (irritating to eyes)
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of this study, the test substance Aldehyde C8 was determined to be irritating when tested in rabbit eyes.
Executive summary:

In a study conducted in 1994, the potential of the test substance Aldehyde C8 to cause irritation to the eyes was determined in rabbits. Three New Zealand White rabbits were administered a single ocular dose of 0.1 mL of the test substance undiluted and they were observed for 14 days after instillation. The test substance was administered into one eye of each rabbit with the other eye remaining as the untreated control. Following application, the treated eye elicited corneal opacity. iridial inflammation and well-defined conjunctival irritations. However, all reactions had resolved by14 days after instillation.

Under the conditions of this study, the test substance Aldehyde C8 was determined to be irritating when tested in rabbit eyes. Based on these results, the test substance should be classified as a Category 2 eye irritant according to Regulation EC No. 1272/2008.