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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:
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 Oleic Acid, Lauric Acid, Palmitic Acid, Myristic Acid, and Stearic Acid
Author:
Cosmetic Ingredient Review Expert Panel
Year:
1987
Bibliographic source:
Journal of American College of Toxicology, 6(3):321-401, 1987

Materials and methods

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

Test material

Constituent 1
Chemical structure
Reference substance name:
Palmitic acid
EC Number:
200-312-9
EC Name:
Palmitic acid
Cas Number:
57-10-3
Molecular formula:
C16H32O2
IUPAC Name:
Hexadecanoic acid
Test material form:
solid
Details on test material:
- Name of test material (as cited in study report): Palmitic acid
- Molecular formula: C16H32O2
- Molecular weight: 256.4268 g/mol
- Substance type: organic
- Physical state: solid
- Smiles: C(CCCCCCCCCC)CCCCC(=O)O
- InChI: 1S/C16H32O2/c1-2-3-4-5-6-7-8-9-10-11-12-13-14-15-16(17)18/h2-15H2,1H3,(H,17,18)
Specific details on test material used for the study:
- Name of test material (as cited in study report): Palmitic acid
- Molecular formula: C16H32O2
- Molecular weight: 256.4268 g/mol
- Substance type: organic
- Physical state: solid
- Smiles: C(CCCCCCCCCC)CCCCC(=O)O
- InChI: 1S/C16H32O2/c1-2-3-4-5-6-7-8-9-10-11-12-13-14-15-16(17)18/h2-15H2,1H3,(H,17,18)

Test animals / tissue source

Species:
rabbit
Strain:
other: albiino
Details on test animals or tissues and environmental conditions:
no data available

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes
Amount / concentration applied:
0.1ml
Duration of treatment / exposure:
single exposure
Observation period (in vivo):
no data available
Duration of post- treatment incubation (in vitro):
no data available
Number of animals or in vitro replicates:
6
Details on study design:
no data available

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:
other: no data available
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
No signs of irritation were observed

Any other information on results incl. tables

Table: Results of the ocular irritation study

Test material

Concentration

No of animals

Method*

Results

Palmitic acid [commercial grade]

0.1ml

6 albino rabbits

Draize

No irritation observed

*Draize method – usually involves instillation of single volume of 0.1ml test chemical into one eye, untreated eye = control.

Applicant's summary and conclusion

Interpretation of results:
other: not irritating
Conclusions:
No signs of irritation were observed in the treated eyes.
Based on the observations, Palmitic acid can be considered to be not irritating to eyes.
Executive summary:

The eye irritation potential of Palmitic acid was assessed in rabbits according to Draize method

0.1ml undiluted Palmitic acid was instilled in to one eye of 6 albino rabbits and the untreated eye served as control. The rabbits were observed for signs of irritation (duration not mentioned).

No signs of ocular irritation were observed in the treated eyes.

Based on the observations, Palmitic acid can be considered to be not irritating to eyes.

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