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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)

Data source

Reference
Reference Type:
publication
Title:
Fatty acid amido propyl dimethylamines: Human health tier II Assessment
Author:
NICNAS
Year:
2019
Bibliographic source:
NICNAS Health Assessment
Report date:
2019

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
- Short description of test conditions: In a non guideline study, 4 male white rabbits were treated with a single application of 0.1 mL of the chemical diluted to 1% in distilled water in one eye.
The eye was not rinsed after application.
GLP compliance:
not specified
Remarks:
Not specified in the NICNAS report

Test material

Constituent 1
Reference substance name:
Amides, coco, N-[3-(dimethylamino)propyl]
EC Number:
268-771-8
EC Name:
Amides, coco, N-[3-(dimethylamino)propyl]
Cas Number:
68140-01-2
IUPAC Name:
Amines, C12-18, alkyldimethyl
Test material form:
liquid

Test animals / tissue source

Species:
rabbit

Test system

Vehicle:
water
Remarks:
Chemical diluted to 1% in distilled water
Amount / concentration applied:
0.1 mL
Duration of treatment / exposure:
not specified
Observation period (in vivo):
1 and 6 hours
Number of animals or in vitro replicates:
4 male
Details on study design:
In a non guideline study, 4 male white rabbits were treated with a single application of 0.1 mL of the chemical diluted to 1% in distilled water in one eye.
The eye was not rinsed after application.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
24/48/72 h
Score:
ca. 3
Max. score:
5
Reversibility:
fully reversible
Remarks on result:
probability of moderate irritation
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
ca. 3
Max. score:
5
Reversibility:
fully reversible
Remarks on result:
probability of moderate irritation
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
ca. 3
Max. score:
5
Reversibility:
fully reversible
Remarks on result:
probability of moderate irritation
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 3
Max. score:
5
Reversibility:
fully reversible
Remarks on result:
probability of moderate irritation
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
24/48/72 h
Score:
ca. 3
Max. score:
5
Reversibility:
fully reversible
Remarks on result:
probability of moderate irritation
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
ca. 3
Max. score:
5
Reversibility:
fully reversible
Remarks on result:
probability of moderate irritation
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
ca. 3
Max. score:
5
Reversibility:
fully reversible
Remarks on result:
probability of moderate irritation
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 3
Max. score:
5
Reversibility:
fully reversible
Remarks on result:
probability of moderate irritation
Irritation parameter:
iris score
Basis:
animal #4
Time point:
24/48/72 h
Score:
ca. 3
Max. score:
5
Reversibility:
fully reversible
Remarks on result:
probability of moderate irritation
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
ca. 3
Max. score:
5
Reversibility:
fully reversible
Remarks on result:
probability of moderate irritation
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
ca. 3
Max. score:
5
Reversibility:
fully reversible
Remarks on result:
probability of moderate irritation
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 3
Max. score:
5
Reversibility:
fully reversible
Remarks on result:
probability of moderate irritation
Irritation parameter:
cornea opacity score
Basis:
animal #4
Time point:
24/48/72 h
Score:
ca. 3
Max. score:
5
Reversibility:
fully reversible
Remarks on result:
probability of moderate irritation
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
ca. 3
Max. score:
5
Reversibility:
fully reversible
Remarks on result:
probability of moderate irritation
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
ca. 3
Max. score:
5
Reversibility:
fully reversible
Remarks on result:
probability of moderate irritation
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 3
Max. score:
5
Reversibility:
fully reversible
Remarks on result:
probability of moderate irritation
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
48 h
Reversibility:
fully reversible
Remarks on result:
probability of moderate irritation
Irritant / corrosive response data:
Moderate conjunctivae reaction was observed at 1 and 6 hours after application, but was fully reversible after 48h.

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria
Conclusions:
The corrosivity of the chemical cannot be excluded due to higher concentration not tested.
Based on its property as a skin corrosive, it is expected that the chemical would cause irreversible eye damage at high concentration

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