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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
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:
1983
Report date:
1983

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
adopted in 2017
Deviations:
yes
Remarks:
limited reporting, no anesthetics used
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
(carboxymethyl)dimethyl-3-[(1-oxotetradecyl)amino]propylammonium hydroxide
EC Number:
261-684-6
EC Name:
(carboxymethyl)dimethyl-3-[(1-oxotetradecyl)amino]propylammonium hydroxide
Cas Number:
59272-84-3
Molecular formula:
C21H42N2O3
IUPAC Name:
(carboxymethyl)dimethyl-3-[(1-oxotetradecyl)amino]propylammonium hydroxide
Test material form:
solid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
not specified

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 100 mg
Duration of treatment / exposure:
2 seconds, 4 seconds, or not washed out
Observation period (in vivo):
1 h, 24 h, 48 h, 72 h and 7 days
Number of animals or in vitro replicates:
3 per group
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: with 20 mL of lukewarm water
- Time after start of exposure: either not washed out or after 2 seconds or after 4 seconds

SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: not specified

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
of 3 animals (eyes not washed)
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
mean
Remarks:
of 3 animals (eyes not washed)
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
not fully reversible within: 7 days in one animal
Remarks:
the other 2 animals were fully reversible within 7 days
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
of 3 animals (eyes not washed)
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
of 3 animals (eyes not washed)
Time point:
24/48/72 h
Score:
1.4
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritant / corrosive response data:
Eyes not washed out:
See individual results results in table under "Any other information on results incl. tables.
In addition vascularisation of the cornea was observed in all rabbits and ulcus cornea in one rabbit in the test where eyes where not washed out.

Eyes washed out after 2 seconds:
After one hour the eye effects observed generally consisted of slight corneal opacity, slight iritis, slight or moderate redness and swelling of the conjunctivae and moderate discharge.
In the course of the seven-day observation period these effects cleared up only partly or not at all.
After seven days the following eye effects were observed:
- slight corneal opacity in 3/3 rabbits
- slight iritis in 2/3 rabbits
- slight or moderate redness and slight swelling of the conjunctivae in 3/3 rabbits
- slight discharge in 2/3 rabbits
In addition vascularization of the cornea was observed in 3/3 rabbits and ulcus corneae in 2/3 rabbits.

Eyes washed out after 4 seconds:
After one hour the eye effects observed consisted of slight corneal opacity, slight iritis, slight or moderate redness of the conjunctivae, moderate swelling of the conjunctivae and moderate or severe discharge.
In the course of the seven-day observation period these effects cleared up only partly or not at all.
After seven days the following eye effects were observed:
- slight or moderate corneal opacity in 3/3 rabbits
- slight iritis in 2/3 rabbits
- slight or moderate redness and swelling of the conjunctivae in 3/3 rabbits
- moderate discharge in 2/3 rabbits
In addition, vascularization of the cornea was observed in 3/3 rabbits and ulcus corneae in 1/3 rabbit.
Other effects:
- Effects of rinsing or washing: Irrigation of the treated eyes with water starting 2 or 4 seconds after administration of the test material, was not found to be benefical.

For ethical reasons and based on the following observations and arguments all rabbits were killed after an observation period of seven days, i.e. seven days after the instillation of the test material.
- Cornea effects remained unchanged during the seven days after instillation
- The eye lesions observed during the seven days after instillation, seemed to result in an increasing discomfort for the animals
- Prolongation of the observation period to 21 days would according to the study director not change the conclusion on the basis of the results obtained

Any other information on results incl. tables

Individual results from test where eyes where not washed out.

Cornea:

Animal No

Evaluation after 

Positive responder?

Means score …

Reversible?

 

1h

24 h

48 h

72 h

7 days

>= 3

>= 1

 

1

1

1

1

1

1

 

 

No

 

Mean 24/48/72 h = 1

 

No

yes

2

1

1

1

1

1

 

 

No

 

Mean 24/48/72 h = 1

 

No

Yes

3

1

1

1

1

1

 

 

No

 

Mean 24/48/72 h = 1

 

no

Yes

 

Iris:

Animal No

Evaluation after 

Positive responder?

Means score …

Reversible?

 

1h

24 h

48 h

72 h

7 days

>= 1.5

>= 1

 

1

1

1

1

1

0

 

 

Yes

 

Mean 24/48/72 h = 1

 

No

yes

2

1

1

1

1

1

 

 

No

 

Mean 24/48/72 h = 1

 

No

Yes

3

1

1

1

1

0

 

 

yes

 

Mean 24/48/72 h = 1

 

no

Yes

 

Conjuntivial redness:

Animal No

Evaluation after 

Positive responder?

Means score …

Reversible?

 

1h

24 h

48 h

72 h

7 days

>= 2

 

1

1

2

2

2

1

 

No

 

Mean 24/48/72 h = 2

 

Yes

2

2

2

2

2

2

 

No

 

Mean 24/48/72 h = 2

 

Yes

3

2

2

2

2

1

 

No

 

Mean 24/48/72 h = 2

 

Yes

 

Conjuntivial chemosis:

Animal No

Evaluation after 

Positive responder?

Means score …

Reversible?

 

1h

24 h

48 h

72 h

7 days

>= 2

 

1

1

1

1

1

1

 

No

 

Mean 24/48/72 h = 1

 

No

2

2

2

2

2

2

 

No

 

Mean 24/48/72 h = 2

 

Yes

3

2

2

1

1

1

 

No

 

Mean 24/48/72 h = 1.3

 

No

Applicant's summary and conclusion

Interpretation of results:
other: Category 1 based on CLP criteria (EU criteria according to Regulation (EC) No. 1272/2008)