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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
Study period:
January 1978
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

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

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Principles of method if other than guideline:
The study report calculates scores based on grading of ocular lesions that are similar or equivalent (in many cases identical) as those described in Table 1 of OECD test guideline 405 (2nd Oct 2012). The study however, uses the initial figure to calculate a final score out of 80 for cornea, 10 for iris and 20 for conjunctivae.
Based on the calculation given, and that the results for unrinsed eyes are all maximum scores and irreversible, it is easy to adapt the give scores of 80, 10 and 20 to the modern maximum scores of 4, 2 and 3.
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
3-[[3-(dimethylamino)propyl]amino]propiononitrile
EC Number:
274-159-1
EC Name:
3-[[3-(dimethylamino)propyl]amino]propiononitrile
Cas Number:
69852-45-5
Molecular formula:
C8H17N3
IUPAC Name:
3-{[3-(dimethylamino)propyl]amino}propanenitrile
impurity 1
Chemical structure
Reference substance name:
3,3'-[[3-(dimethylamino)propyl]imino]bispropiononitrile
EC Number:
275-331-9
EC Name:
3,3'-[[3-(dimethylamino)propyl]imino]bispropiononitrile
Cas Number:
71326-27-7
Molecular formula:
C11H20N4
IUPAC Name:
3,3'-{[3-(dimethylamino)propyl]imino}dipropanenitrile
Test material form:
liquid
Remarks:
colorless

Test animals / tissue source

Species:
rabbit
Strain:
Himalayan
Details on test animals or tissues and environmental conditions:
The animals were housed individually in metal cages, were kept at a constant room temperature of 22 + 1 C, at a relative humidity of 55 + 5 % and on a 10 hour light cycle day. The animals had ad libitum access to Standard rabbit food - NAFAG, Gossau SG - and water. Prior to treatment they were adapted to our laboratories for a minimum of 4 days. Only rabbits with normal ophthalmic findings were used for these tests.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.1ml of the test material was inserted into the conjunctival sac of the left eye
Duration of treatment / exposure:
Eyelids were gently closed for on second.
In 3 of the 6 rabbits approximately 30 seconds after treatment the treated eye was flushed with 10 ml of lukewarm water.
Observation period (in vivo):
7 days.
Eye irritation was appraised with a slit-lamp on day 1, 2, 3, 4 and 7
Number of animals or in vitro replicates:
6 rabbits

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
Unrinsed eyes
Time point:
24/48/72 h
Score:
80
Max. score:
80
Reversibility:
not reversible
Remarks on result:
positive indication of irritation
Remarks:
Because of irreversible maximum irritation effect all rabbits were kill after an observation period of 72 hours.
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
Eyes rinsed after 30 seconds
Time point:
7 d
Score:
41.3
Max. score:
80
Reversibility:
not fully reversible within: 7 days
Remarks on result:
positive indication of irritation
Irritation parameter:
iris score
Basis:
mean
Remarks:
Unwashed eyes
Time point:
7 d
Score:
20
Max. score:
20
Reversibility:
not reversible
Remarks on result:
positive indication of irritation
Irritation parameter:
iris score
Basis:
mean
Remarks:
Eyes rinsed 30 seconds after treatment
Time point:
7 d
Score:
3.7
Max. score:
10
Reversibility:
fully reversible within: 7 days
Remarks on result:
positive indication of irritation
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
Unwashed eyes
Time point:
7 d
Score:
20
Max. score:
20
Reversibility:
not reversible
Remarks on result:
positive indication of irritation
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
Eyes rinsed 30 seconds after treatment
Time point:
7 d
Score:
12.3
Max. score:
20
Reversibility:
not reversible
Remarks on result:
positive indication of irritation
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
with eyes rinsed 30 sec. after treatment
Time point:
24/48/72 h
Score:
42.2
Max. score:
60
Reversibility:
not fully reversible within: 72h
Irritation parameter:
iris score
Basis:
mean
Remarks:
with eyes not rinsed after treatment
Time point:
24/48/72 h
Score:
10
Max. score:
10
Reversibility:
not reversible
Remarks on result:
positive indication of irritation
Remarks:
Because of irreversible maximum irritation effect all rabbits were kill after an observation period of 72 hours.
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
with eyes not rinsed after treatment
Time point:
24/48/72 h
Score:
20
Max. score:
20
Reversibility:
not reversible
Remarks on result:
positive indication of irritation
Remarks:
Because of irreversible maximum irritation effect all rabbits were kill after an observation period of 72 hours.
Irritation parameter:
chemosis score
Remarks:
with eyes not rinsed after treatment
Basis:
mean
Time point:
24/48/72 h
Score:
20
Max. score:
20
Reversibility:
not reversible
Remarks on result:
positive indication of irritation

Any other information on results incl. tables

Eye irritation in individual rabbits with eyes not rinsed after treatment:

  Rabbit 1 ♂ Rabbit 2 ♂ Rabbit 3 ♂
Days after Application Cornea Iris Conjunctivae Cornea Iris Conjunctivae Cornea Iris Conjunctivae
1 80 10 20 80 10 20 80 10 20
2 80 10 20 80 10 20 80 10 20
3 80 10 20 80 10 20 80 10 20
4 Because of the irreversible maximum irritation effect, all rabbits were killed after an observation period of 72 hours
7

Eye irritation in individual rabbits with eyes rinsed 30 sec. after treatment:

  Rabbit 4 ♀ Rabbit 5 ♀ Rabbit 6 ♀
Days after Application Cornea Iris Conjunctivae Cornea Iris Conjunctivae Cornea Iris Conjunctivae
1 40 0 10 40 5 14 60 10 16
2 30 0 10 30 0 12 60 10 16
3 30 0 10 30 0 12 60 10 16
4 30 0 8 30 0 12 60 10 16
7 30 0 6 30 0 10 60 10 14

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
Under the conditions of this experiment the test material was found to cause a marked irritation when applied to the rabbit eye mucosa. Rinsing the eyes following instillation was of little but assessable effect