Sodium 2-[(1-oxododecyl)amino]ethanesulphonate

Eye irritation

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

Test material information

Constituent 1

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.