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Diss Factsheets

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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Appraisal of the safety of chemicals in food, drugs and cosmetics, FDA, Draize, 1959
Deviations:
not specified
Principles of method if other than guideline:
Information about the method, described in the study report ( Draize test: eye irritation), is given in the free text field "methods and materials".
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
3-hydroxypropiononitrile
EC Number:
203-704-8
EC Name:
3-hydroxypropiononitrile
Cas Number:
109-78-4
Molecular formula:
C3H5NO
IUPAC Name:
3-hydroxypropanenitrile
Details on test material:
- Name of test material (as cited in study report): Ethylencyanhydrin
- Substance type: Aliphatic Nitrile
- Physical state: liquid
- Analytical purity: as supplied by producer: purity in the test report not mentioned, but probably > 98,5%
- Impurities (identity & concentrations): no data availible by the study report, but according to the current product information sheet the
impurities are: glykol <1%, formic acid: max 0.06%, HCN: max 0.0010% , water: max 0.10%.
- Stability under test conditions: no data
- Storage condition of test material: no data

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 available
- Weight at study initiation: 2.4-2.6 kg
- Housing: individual housing
- Diet (e.g. ad libitum): standard diet
- Water: ad libitum
- Acclimation period: no data availible
- Air changes (per hr): no data availible
- Photoperiod (hrs dark / hrs light): 12 h light/12h dark
- Humidity: 45-55%
- Room temperature: 20 ±1°C

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: second eye without treatment served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml undiluted test substance (ethylencyanhydrin)
Duration of treatment / exposure:
single application, 7 days of exposure
Observation period (in vivo):
1, 2, 8 hours; 1, 2, 3, 4, 5, 6, 7 days
Number of animals or in vitro replicates:
6 test animals
Details on study design:
Test method:
An amount of 0.1 ml undiluted test substance (Ethylene cyanhydrin) was applicated into 
the conjunctival sac of the left eye of each test animal. 6 animals were used for the testing. 
The second eye served in each case as the control. The occurence of irritant reactions
was recorded and scored according to the scoring system shown in "details on study design". 
The final result (according to GHS classification sheme) is calculated as the mean score 
(in the categories: corneal opacity, iritis, conjunctival redness, conjunctival chemosis) 
following grading after 24, 48 and 72 hours.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no washing

SCORING SYSTEM:
Cornea:
opacity: degree of density (reading should be taken from most dense area)
No ulceration or opacity : 0
Scattered or diffuse areas of opacity (other than slight dulling of normal lustre);
deatails of iris clearly visible : 1
Easily discernible translucent area; details of iris slightly obscured: 2
Nacrous area; 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; iris reactive to light : 1
Hemorrhage, gross destruction, or no reaction to light: 2

Conjunctiva:
Redness(refers to palpebral and bulbar conjunctivae; exluding cornea and iris)
Blood vessels normal: 0
Some blood vessels hyperaemia (injected): 1
Diffuse, crimson colour, individual vessels not easily discenible: 2
Diffuse beefy red: 3

Chemosis:
Swelling (refers to lids and/or nictating membranes)
No swelling: 0
Some swelling above normal: 1
Obvious swelling with partial eversion of lids: 2
Swelling with lids about half closed: 3
Swelling with lids more than half closed: 4

Maximum attainable score: 13

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
iris score
Basis:
mean
Score:
ca. 0
Max. score:
2
Reversibility:
fully reversible within: 0 hr
Remarks on result:
other: Hazard category: none
Irritation parameter:
cornea opacity score
Basis:
mean
Score:
ca. 0
Max. score:
4
Reversibility:
fully reversible within: 0 hr
Remarks on result:
other: Hazard category: none
Irritation parameter:
conjunctivae score
Basis:
mean
Score:
ca. 0.83
Max. score:
3
Reversibility:
fully reversible within: 72 hr
Remarks on result:
other: Hazard category: none
Irritation parameter:
chemosis score
Basis:
mean
Score:
ca. 0.28
Max. score:
4
Reversibility:
fully reversible within: 72 hr
Remarks on result:
other: Hazard category: none
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: no effects observed
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: no effects observed
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: no effects observed
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: no effects observed
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: no effects observed
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: no effects observed
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects observed
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects observed
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects observed
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects observed
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects observed
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects observed
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.66
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.66
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
24/48/72 h
Score:
1.33
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0.66
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0.66
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effect observed
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effect observed
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
24/48/72 h
Score:
1.33
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
chemosis score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effect observed
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effect observed
Remarks on result:
no indication of irritation

Any other information on results incl. tables

 Reevaluation of the test results according to GHS criteria for classification:

   Iritis [scores]      Mean Draize  Reversibility [scores]    
 Animal No.  after 24h  after 48h  after 72h   score  in 7 days  in 21 days
 1  0  0  0  0  0  -  
 2  0  0  0  0  0  -  
 3  0  0  0  0  0  -  
 4  0  0  0  0  0  -  
 5  0  0  0  0  0  -  
 6  0  0  0  0  0  -  

 

 Mean iritis score (1-6 animals; 24h, 48h, 72h):   0  (out of 2 scores)
  => Hazard Category:  none

 

   Corneal opacity [scores]      Mean Draize  Reversibility [scores]     
 Animal No.  24h  after 48h  after 72h  score  in 7 days  in 21 days  
 1  0  0  0  0  0  -  
 2  0  0  0  0  0  -  
 3  0  0  0  0  0  -  
 4  0  0  0  0  0  -  
 5  0  0  0  0  0  -  
 6  0   0  0  0  0  -  

 

  Mean corneal opacity score (1-6 animals; 24h, 48h, 72h):  0 (out of 4 scores)
 => Hazard Category: none 

 

   Conjunctiva redness [scores]      Mean Draize  Reversibility [scores]    
 Animal No.  after 24h  after 48h  after 72h  score  in 7 days  in 21 days  
 1  1  1  0  0.66  0  -  
 2  1  1  0  0.66  0  -  
 3  2  1  0  1  0  -  
 4  2  2  0  1.33  0  -  
 5  1  1  0  0.66  0    
 6  1  1  0  0.66  0  -  

  

  Mean conjunctiva redness score (1-6 animals; 24h, 48h, 72h):  0.83 (out of 3 scores)
 => Hazard Category: none 

   Conjunctiva chemosis [scores]      Mean Draize  Reversibility [scores]    
 Animal No.  after 24h  after 48h  after 72h  score  in 7 days  in 21 days  
 1  0  0  0  0  0  -  
 2  0  0  0  0  0  -  
 3  0  1  0  0.33  0  -  
 4  2  2  0  1.33  0  -  
 5  0  0  0  0  0  -  
 6   0  0  0  0  0  -  

 

  Mean conjunctiva chemosis score (1-6 animals; 24h, 48h, 72h):  0.28 (out of 4 scores)
 Hazard Category: none 

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
According to GHS classification criteria the test substance ethylencyanhydrin has to be classified as non irritating to eyes (hazard category: none).
Executive summary:

Mean conjunctiva redness and mean conjunctica chemosis score were determined to be 0.83 and 0.28 respectively. The effects were

fully reversible within 72h p.a. No other effects were observed. 

Conclusion:

According to GHS classification criteria the test substance ethylencyanhydrin has to be classified as non irritating to eyes (hazard 

category: none).