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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:
weight of evidence
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: Scientific Panel Review Article. Results according to OECD scoring system, but without individual scores. No data on GLP.

Data source

Reference
Reference Type:
review article or handbook
Title:
Unnamed
Year:
1982

Materials and methods

Principles of method if other than guideline:
-Principle of test: The test was performed according to Draize method and evaluation. Rabbits were exposed to ammonium stearate at a concentration of 100%. Eyes were rinsed after treatment. Effects were observed for 72h.
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Ammonium stearate
EC Number:
213-695-2
EC Name:
Ammonium stearate
Cas Number:
1002-89-7
Molecular formula:
C18H36O2.H3N
IUPAC Name:
ammonium stearate

Test animals / tissue source

Species:
rabbit
Strain:
not specified

Test system

Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
Test item concentration: 100%
Observation period (in vivo):
72h
Details on study design:
Eyes were rinsed.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
24 h
Score:
3
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
48 h
Score:
1
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
72 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
no indication of irritation

Applicant's summary and conclusion

Interpretation of results:
other: No category (CLP Regulation EC no. 1272/2008)
Conclusions:
Ammonium stearate is not irritating for eyes.
Executive summary:

An Eye Irritation test according to Draize Method was performed on Ammonium stearate. Rabbits were exposed to a test item concentration of 100%. Eyes were rinsed after treatment and the scored were 3, 1 and 0 on days 1, 2 and 3 respectively. Based on these results, ammonium stearate was determined to be not irritating for eyes.