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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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well documented report which meets basic scientific principles
Cross-reference
Reason / purpose for cross-reference:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report date:
1979

Materials and methods

Principles of method if other than guideline:
Draize Test
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Trimethylamine
EC Number:
200-875-0
EC Name:
Trimethylamine
Cas Number:
75-50-3
Molecular formula:
C3H9N
IUPAC Name:
N,N-dimethylmethanamine
Details on test material:
- Name of test material (as cited in study report): Trimethylamin 45 % (liquid)

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2.97 kg
- Diet: SSNIFF, ad libitum
- Water: tap water, ad libitum

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the adjacent eye served as saline-control.
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 µL
Duration of treatment / exposure:
single application, eyes were not washd out
Observation period (in vivo):
14 days
Number of animals or in vitro replicates:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24 h - 48 h - 72 h
Score:
2.5
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: Test substance caused necrosis
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24 h - 48 h - 72 h
Score:
1
Max. score:
2
Reversibility:
not fully reversible within: 14 days
Remarks on result:
other: ciliar injection
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24 h - 48 h - 72 h
Score:
2
Max. score:
3
Reversibility:
not fully reversible within: 14 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24 h - 48 h - 72 h
Score:
2.4
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24 h
Score:
2
Max. score:
4
Reversibility:
other: the readings at 8 and 14 days were due to suppuration not possible
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24 h
Score:
2
Max. score:
4
Reversibility:
other: the readings at 8 and 14 days were due to suppuration not possible
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24 h
Score:
2
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
48 h
Score:
2
Max. score:
4
Reversibility:
other: the readings at 8 and 14 days were due to suppuration not possible
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
48 h
Remarks on result:
not determinable
Remarks:
the readings at 48 hours, 8 and 14 days were due to suppuration not possible
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
48 h
Score:
3
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
72 h
Score:
3
Max. score:
4
Reversibility:
other: the readings at 8 and 14 days were due to suppuration not possible
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
72 h
Score:
3
Max. score:
4
Reversibility:
other: the readings at 8 and 14 days were due to suppuration not possible
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
72 h
Score:
3
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 8 days
Remarks on result:
not determinable
Remarks:
the readings at 8 and 14 days were due to suppuration not possible
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: 8 days
Remarks on result:
not determinable
Remarks:
the readings at 8 and 14 days were due to suppuration not possible
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: 8 days
Score:
4
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
14 d
Remarks on result:
not determinable
Remarks:
the readings at 8 and 14 days were due to suppuration not possible
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
14 d
Remarks on result:
not determinable
Remarks:
the readings at 8 and 14 days were due to suppuration not possible
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
14 d
Score:
4
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Reversibility:
other: the readings at 8 and 14 days were due to suppuration not possible
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 8 days
Remarks on result:
not determinable
Remarks:
the readings at 8 and 14 days were due to suppuration not possible
Irritation parameter:
iris score
Basis:
animal #1
Time point:
14 d
Remarks on result:
not determinable
Remarks:
the readings at 8 and 14 days were due to suppuration not possible
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24 h
Score:
1
Reversibility:
other: the readings at 48 h, 8 and 14 days were due to suppuration not possible
Irritation parameter:
iris score
Basis:
animal #2
Time point:
48 h
Remarks on result:
not determinable
Remarks:
the readings at 8 and 14 days were due to suppuration not possible
Irritation parameter:
iris score
Basis:
animal #2
Time point:
72 h
Score:
1
Reversibility:
other: the readings at 8 and 14 days were due to suppuration not possible
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: 8 days
Remarks on result:
not determinable
Remarks:
the readings at 8 and 14 days were due to suppuration not possible
Irritation parameter:
iris score
Basis:
animal #2
Time point:
14 d
Remarks on result:
not determinable
Remarks:
the readings at 8 and 14 days were due to suppuration not possible
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Reversibility:
other: the readings at 8 and 14 days were due to suppuration not possible
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: 8 days
Remarks on result:
not determinable
Remarks:
the readings at 8 and 14 days were due to suppuration not possible
Irritation parameter:
iris score
Basis:
animal #3
Time point:
14 d
Remarks on result:
not determinable
Remarks:
the readings at 8 and 14 days were due to suppuration not possible
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
other: the readings at 8 and 14 days were due to suppuration not possible
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 8 days
Remarks on result:
not determinable
Remarks:
the readings at 8 and 14 days were due to suppuration not possible
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
14 d
Remarks on result:
not determinable
Remarks:
the readings at 8 and 14 days were due to suppuration not possible
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24 h
Score:
2
Max. score:
2
Reversibility:
other: the readings at 8 and 14 days were due to suppuration not possible
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
48 h
Remarks on result:
not determinable
Remarks:
the readings at 48 hours, 8 and 14 days were due to suppuration not possible
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
72 h
Score:
2
Max. score:
2
Reversibility:
other: the readings at 8 and 14 days were due to suppuration not possible
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 8 days
Remarks on result:
not determinable
Remarks:
the readings at 8 and 14 days were due to suppuration not possible
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
14 d
Remarks on result:
not determinable
Remarks:
the readings at 8 and 14 days were due to suppuration not possible
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
other: the readings at 8 and 14 days were due to suppuration not possible
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 8 days
Remarks on result:
not determinable
Remarks:
the readings at 8 and 14 days were due to suppuration not possible
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
14 d
Remarks on result:
not determinable
Remarks:
the readings at 8 and 14 days were due to suppuration not possible
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
not reversible
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 8 days
Score:
3
Max. score:
3
Reversibility:
not reversible
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
14 d
Score:
3
Max. score:
3
Reversibility:
not reversible
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24 h
Score:
2
Max. score:
3
Reversibility:
not reversible
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
48 h
Score:
3
Max. score:
3
Reversibility:
not reversible
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
72 h
Score:
3
Max. score:
3
Reversibility:
not reversible
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 8 days
Score:
3
Max. score:
3
Reversibility:
not reversible
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
14 d
Score:
3
Max. score:
3
Reversibility:
not reversible
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24 h
Score:
2
Max. score:
3
Reversibility:
not reversible
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
48 h
Score:
3
Max. score:
3
Reversibility:
not reversible
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
72 h
Score:
3
Max. score:
3
Reversibility:
not reversible
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 8 days
Score:
3
Max. score:
3
Reversibility:
not reversible
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
14 d
Score:
3
Max. score:
3
Reversibility:
not reversible

Any other information on results incl. tables

Table 1

 Animal 1/2/3  24 h  48 h  72 h  8 days  14 days            
A) corneal opacity  2/2/2  2/x/3  3/3/3  x/x/4   x/x/4
B) area  4/4/4  4/x/4  4/4/4  x/x/4   x/x/4
 a = AxBx5  40/40/40  40/-/60  60/60/60  -/-/-   -/-/-
           
 Iris  1/1/1  1/x/1  1/1/1  x/x/x   x/x/x
 b = Ax5  5/5/5  5/-/5  4/4/4  -/-/-   -/-/-
         

 Conjunctiva

 

 

 

 

 

 A) erythema

 2/2/2

 2/x/2

 2/2/2

 x/x/3

  x/x/3

 B) chemosis

 2/2/2

 2/3/3

 2/3/3

 3/3/3

  3/3/3

 C) secretion

 1/1/1

 3/3/3

 3/3/3

 3/3/3

  3/3/3

 c = (A+B+C)x2

 10/10/10

 14/12/16

 14/16/16

 -/-/-

  -/-/-

 

 

 

 

 

 

 Sum=a+b+c

  55/55/55  59/12/81  79/81/81 -/-/-    -/-/-

x: reading due to suppuration not possible.

The application of the test substance caused red-brown discoloration of the mucous and nictating membrane. After 24 h cliliar injection was noted in all 3 animals. After 8 days severe corneal opacity was noted in 1 animal. Due to purulent exsudate in the other two animals the corneal opacity score was not possible to determine.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
The application of the test substance caused red-brown discoloration of the mucous and nictating membrane. After 24 h cliliar injection was noted in all 3 animals. After 8 days severe corneal opacity was noted in 1 animal. Due to purulent exsudate in the other two animals the corneal opacity score was not possible to determine.
Trimethylamine (aqueous solution): Skin Corr. 1B, H314: Causes severe skin burns and eye damage
Trimethylamine (gaseous form): Eye damage 1, H318: Causes serious eye damage
Executive summary:

A Draize test was performed on 3 rabbits (Vienna White) by BASF (1979). One single application was done with 100 µL, the eyes were not washed out afterwards. The test duration was 14 days. The application of the test substance caused red-brown discoloration of the mucous and nictating membrane. After 24 h ciliar injection was noted in all 3 animals. After 8 days severe corneal opacity was noted in 1 animal. Due to purulent exsudate in the other two animals the corneal opacity score was not possible to determine.