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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
31 May - 03 June 1983
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP - guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report date:
1983

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Isonicotinaldehyde
EC Number:
212-832-3
EC Name:
Isonicotinaldehyde
Cas Number:
872-85-5
Molecular formula:
C6H5NO
IUPAC Name:
pyridine-4-carbaldehyde
Test material form:
other: liquid
Details on test material:
- Name of test material (as cited in study report): Pyridin-4-aldehyd
- Physical state: liquid
- Analytical purity: minimum 98% (GC)
- Purity test date : no data
- Lot/batch No.: 05394
- Stability under test conditions: stable

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Kleintierfarm Madoerin AG , 4414 Fuellinsdorf , Switzerland
- Age at study initiation: 12 weeks
- Weight at study initiation: 2,4 - 2,8 kg
- Housing: The animals were caged individually in stainless steel cages , with automatic drinking water supply and cleaning system
- Diet (e.g. ad libitum): rabbit maintenance diet (standard Kliba 341 (Klingentalmühle AG , 4303 Kaiseraugst , Switzerland) , ad libitum
- Water (e.g. ad libitum): tap water , ad libitum
- Acclimation period: 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +-2
- Humidity (%): 55 +-10
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the untreated eye served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0,1 ml/rabbit
Duration of treatment / exposure:
single application, duration not specified
Observation period (in vivo):
72 h
Number of animals or in vitro replicates:
3 (1 male / 2 females)
Details on study design:
Route of administration :
Single , into the conjunctival sac of the rabbit eye

Dose application :
The test substance was placed into the conjunctival sac of the left eye of each animal after retracting the lower lids from the eye ball . The eyelids were then gently held closed for about one second in order to prevent loss of the test substance . The right eye was untreated and served as control .
The eyes were examined and the grade of ocular reactions recorded at 1 , 24 , 48 and 72 hours after treatment .
In addition , the coloration of the sclera/cornea was recorded in connection with the colour of the test substance .


REMOVAL OF TEST SUBSTANCE
- Washing (if done): the eye was not washed after treatment

SCORING SYSTEM: Draize scoring system

TOOL USED TO ASSESS SCORE: slit lamp 30 SL (C. Zeiss AG , Zuerich/Switzerland) and Varta Cliptrix diagnostic-lamp (A. Riegger , Basel/Switzerland)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: mean over 1,24,48 and 72 h
Score:
2.5
Max. score:
4
Reversibility:
not specified
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: mean over 1,24,48 and 72 h
Score:
3.75
Max. score:
4
Reversibility:
not specified
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: mean over 1,24,48 and 72 h
Score:
4
Max. score:
4
Reversibility:
not specified
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: mean over 1,24,48 and 72 h
Score:
1
Max. score:
2
Reversibility:
not specified
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: mean over 1,24,48 and 72 h
Score:
1.25
Max. score:
2
Reversibility:
not specified
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: mean over 1,24,48 and 72 h
Score:
1.25
Max. score:
2
Reversibility:
not specified
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: mean over 1,24,48 and 72 h
Score:
2.25
Max. score:
3
Reversibility:
not specified
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: mean over 1,24,48 and 72 h
Score:
2
Max. score:
3
Reversibility:
not specified
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: mean over 1,24,48 and 72 h
Score:
2.25
Max. score:
3
Reversibility:
not specified
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: mean over 1,24,48 and 72 h
Score:
3.5
Max. score:
4
Reversibility:
not specified
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: mean over 1,24,48 and 72 h
Score:
3.25
Max. score:
4
Reversibility:
not specified
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: mean over 1,24,48 and 72 h
Score:
4
Max. score:
4
Reversibility:
not specified

Any other information on results incl. tables

Individual findings after application :

Animal 1        Animal 2        Animal 3             
   Cornea Iris   Conjunctivae Cornea  Iris  Conjunctivae  Cornea  Iris  Conjunctivae       
after 1h opaque,whitish,whole iris hardly visible  no reaction  swollen,severe,with eye half closed,redened,severe,lachrymation,severe  opaque,whitish,whole iris hardly visible  sluggish reaction  swollen,severe,lid erosion,with eye half closed,redness,moderate,lachrymation,severe  opaque,whitish,whole,iris not visible  sluggish reaction  swollen,severe,lid erosion,with eye half closed,redness,moderate,lachrymation,severe       
after 24h  opaque,diffuse,iris partly clear visible  swollen,severe,lid erosion,with eye half closed,redened,moderate,with dark-red areas,lachrymation severe  opaque,diffuse,iris hardly visible    swollen,with lids half closed,redness,moderate,with dark-red areas,lachrymation severe  opaque,diffuse,iris not visible   sluggish reaction swollen,severe,severe lid erosion,with eye half closed,redness,moderate,with dark-red areas,lachrymation severe       
after 48h  opaque,whole,diffuse  reddened  swollen,lid erosion,with eye half closed,reddened with dark-red areas,including nictitating membrane,lachrymation severe  opaque,more than after 24 hours,whitish sluggish reaction,reddened  swollen,with lids half closed,redness,moderate,with dark-red areas,lachrymation severe  opaque,diffuse,iris not visible  sluggish reaction  swollen,severe,severe lid erosion,with eye half closed,redness,moderate,with dark-red areas,lachrymation severe       
after 72h  opaque,diffuse,iris partially clear visible  reddened  swollen,moderate,slight lid erosion,redness,moderate,with dark-red areas,lachrymation severe  opaque,severe,iris not visible    swollen,with lids half closed,redness,moderate,with dark-red areas,lachrymation severe  opaque,severe,whole  no reaction  swollen,severe,severe lid erosion,with eye half closed,moderate redness with dark-red areas,severe lachrymation 

Eye irritation scores :

 Animal   Cornea Opacity  Iris  Conjunctivae Redness  Conjunctivae Chemosis  Cumulative scores 
1 after 1 h  4  2  3  4  13 
2  after 1 h  4  1  2  4  11 
3  after 1 h  4  1  2  4  11 
1  after 24 h  2  0  2  4  8 
2  after 24 h  3  1  2  3  9 
3  after 24 h  4  1  2  4  11 
1  after 48 h  2  1  2  4  9 
2  after 48 h  4  1  2  3  10 
3  after 48 h  4  1  2  4  11 
1  after 72 h  2  1  2  2  7 
2  after 72 h  4  2  2  3  11 
3  after 72 h  4  2  3  4  13 

Primary eye irritation scores :

Selected Observations Means Scores 
after 1 h  11,7 
after 24 h  9,3 
after 48 h  10,0 
after 72 h  10,3

Primary irritation score : 10,3

Maximum cumulative score : 13

Applicant's summary and conclusion

Interpretation of results:
Category II
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The study was performed according to the OECD TG405 without deviations and according to the good laboratory practice principles, it is considered to be of highest quality (reliability Klimisch 1). The criteria of validity of the test system are fulfilled. The test material was found to cause a severe irritation when applied to the rabbit eye mucosa.
Executive summary:

The test substance Pyridine-4-aldehyde was investigated for its potential to cause irritation in the rabbit eye according to OECD TG405. 0.1 ml of pure substance was instilled into the conjunctival sac, the untreated eye served as control. Under the conditions of this experiment Pyridine-4-aldehyde was found to cause a severe irritation when applied to the rabbit eye mucosa. A corrosion was observed at each of the measuring intervals in all rabbits. No discoloration of the cornea and conjunctivae which could be related to effects of the test material was observed. The primary irritation index was found to be for the unrinsed eye : 10.3 .