Registration Dossier

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
1990
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
not specified

Test material

1
Chemical structure
Reference substance name:
(Z)-(carboxymethyl)dimethyl-3-[(1-oxo-9-octadecenyl)amino]propylammonium hydroxide
EC Number:
246-584-2
EC Name:
(Z)-(carboxymethyl)dimethyl-3-[(1-oxo-9-octadecenyl)amino]propylammonium hydroxide
Cas Number:
25054-76-6
Molecular formula:
C25H48N2O3
IUPAC Name:
N-(carboxymethyl)-N,N-dimethyl-3-(oleoylamino)propan-1-aminium hydroxide
2
Chemical structure
Reference substance name:
Water
EC Number:
231-791-2
EC Name:
Water
Cas Number:
7732-18-5
Molecular formula:
H2O
IUPAC Name:
Dihydrogen oxide
3
Chemical structure
Reference substance name:
Propane-1,2-diol
EC Number:
200-338-0
EC Name:
Propane-1,2-diol
Cas Number:
57-55-6
Molecular formula:
C3H8O2
IUPAC Name:
propylene glycol
4
Chemical structure
Reference substance name:
Sodium chloride
EC Number:
231-598-3
EC Name:
Sodium chloride
Cas Number:
7647-14-5
Molecular formula:
ClNa
IUPAC Name:
sodium chloride
Test material form:
liquid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Animals were housed individually in stainless steel cages

Test system

Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
0.1 mL of undiluted test material
Observation period (in vivo):
14 days
Number of animals or in vitro replicates:
6
Details on study design:
The test sample was instilled into the conjunctival sac of the right eye of each rabbit, with the left eye serving as a control. The general technique followed that of the Draize method. At each scoring interval the cornea, iris and conjunctivae were examine dand graded for irritation and injury in accordance with the Draize scoring system.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
1.6
Max. score:
4
Reversibility:
fully reversible within:
Remarks:
14 days
Remarks on result:
positive indication of irritation
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0.416
Max. score:
2
Reversibility:
fully reversible within:
Remarks:
14 days
Remarks on result:
positive indication of irritation
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
1.35
Max. score:
4
Reversibility:
fully reversible within:
Remarks:
14 days
Remarks on result:
positive indication of irritation
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
1.6
Max. score:
3
Reversibility:
fully reversible within:
Remarks:
14 days
Remarks on result:
positive indication of irritation

Applicant's summary and conclusion

Interpretation of results:
Category 2A (irritating to eyes) based on GHS criteria
Conclusions:
Substance is classiifed as H319 under GHS classification criteria
Executive summary:

The test sample was instilled into the conjunctival sac of the right eye of each rabbit, with the left eye serving as a control.  The general technique followed that of the Draize method.  At each scoring interval the cornea, iris and conjunctivae were examine dand graded for irritation and injury in accordance with the Draize scoring system.  

Followoijgn gradings over 24, 48 and 72 hours the mean score for cornea opacity, Iritis, conjunctivae redness and swelling was 1.6, 0.41, 1.6 and 1.35, respectively. All effects were fully reversed by the end of the 14 day observation period. Based on the results of this study the test substance is considered to be an eye irritant under GHS classification criteria.