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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
data is from peer reviewed journals

Data source

Reference
Reference Type:
publication
Title:
Final Report on the Safety Assessment of Myristyl Myristate and Isopropyl Myristate
Author:
Cosmetic Ingredients Review Expert Panel
Year:
1982
Bibliographic source:
JOURNAL OF THE AMERICAN COLLEGE OF TOXICOLOGY; Volume 1, Number 4, 1982

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Draize test
Principles of method if other than guideline:
To assess the ocular irritation potential of Isopropyl myristate in rabbits
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Details on test material:
Name of the test chemical: Isopropyl Myristate
Molecular Formula:C17H34O2
Molecular Weight:270.45 g/mol
Substance Type: organic
Physical State: Liquid
Specific details on test material used for the study:
Name of the test chemical: Isopropyl Myristate
Molecular Formula:C17H34O2
Molecular Weight:270.45 g/mol
Substance Type: organic
Physical State: Liquid

Test animals / tissue source

Species:
rabbit
Strain:
not specified
Details on test animals or tissues and environmental conditions:
no data available

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
100% undiluted sample
Duration of treatment / exposure:
Eyes treated daily for 3 consecutive days
Observation period (in vivo):
24,48,72 hours
Duration of post- treatment incubation (in vitro):
no data available
Number of animals or in vitro replicates:
3
Details on study design:
SCORING SYSTEM: Draize method

Results and discussion

In vitro

Other effects / acceptance of results:
no data available

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
No signs of irritation observed

Any other information on results incl. tables

Table 1: Draize Primary Ocular Irritation tests on Isopropyl Myristate

Ingredient

Concentration (%)

Number of rabbits

Primary Irritation Index

 Remarks

24 h

48 h

72 h

Isopropyl myristate

100

3

0.0

0.0

0.0

Eyes treated daily for 3 consecutive days

 

 

Applicant's summary and conclusion

Interpretation of results:
other: not irritating
Conclusions:
The Draize scores after 24, 48 and 72 hours were 0.0 respectively.
Hence, Isopropyl Myristate was considered to be not irritating to rabbit eyes.
Executive summary:

The ocular irritation potential of Isopropyl myristate was assessed in rabbits.

100% Isopropyl myristate was instilled into the eyes of 3 rabbits. The eyes were treated daily for 3 consecutive days. The eyes were scored for signs of irritation at 24, 48 and 72 hours.The Draize scores after 24, 48 and 72 hours were 0.0 respectively.

Hence,Isopropyl Myristate was considered to be not irritating to rabbit eyes.