Hexadecyl palmitate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

1985

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study without detailed documentation

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1985

Report date:

1985

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

1981

Deviations:

yes

Remarks:

Limited documentation

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

adopted in 2015

Deviations:

yes

Remarks:

Limited information on test substance, methods, no reading at 48 hours

GLP compliance:

not specified

Test material

Test material information

1

Reference substance name:

Hexadecyl palmitate

EC Number:

208-736-6

EC Name:

Hexadecyl palmitate

Cas Number:

540-10-3

Molecular formula:

C32H64O2

IUPAC Name:

hexadecyl hexadecanoate

Test material form:

solid

Test animals

Species:

rabbit

Strain:

New Zealand White

Test system

Type of coverage:

occlusive

Preparation of test site:

other:

Remarks:

intact and abraded skin

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 500 mg of the product
- Concentration: pur product

Duration of treatment / exposure:

24 h

Observation period:

72 h
Reading time points: 24 and 72 h

Number of animals:

6 male animals

Details on study design:

OBSERVATION TIME POINTS: 24 h and 72 h

SCORING SYSTEM:
- Method according to OECD GL 404 (Draize scoring system)

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Remarks:

intact skin and abraded skin

Basis:

animal #1

Time point:

other: mean after 24/48/72 h

Score:

0.66

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Remarks on result:

other:

Remarks:

for calculating the mean score, the 48 h values were assumed to be the same as for 24 h

Results 2

Irritation parameter:

erythema score

Remarks:

intact and abraded skin

Basis:

mean

Remarks:

of 5 animals

Time point:

other: mean after 24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other:

Remarks:

not applicable

Remarks on result:

other:

Remarks:

for calculating the mean score, the 48 h values were assumed to be the same as for 24 h

Results 3

Irritation parameter:

edema score

Remarks:

intact skin and abraded skin

Basis:

mean

Remarks:

of 6 animals

Time point:

other: mean after 24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other:

Remarks:

not applicable

Remarks on result:

other:

Remarks:

for calculating the mean score, the 48 h values were assumed to be the same as for 24 h

Any other information on results incl. tables

	24 hours				72 hours
	Erythema		Oedema		Erythema		Oedema
Animal	intact skin	incised skin	intact skin	incised skin	intact skin	incised skin	intact skin	incised skin
#1	0	0	0	0	0	0	0	0
#2	0	0	0	0	0	0	0	0
#3	0	0	0	0	0	0	0	0
#4	1	1	0	0	0	0	0	0
#5	0	0	0	0	0	0	0	0
#6	0	0	0	0	0	0	0	0

Method similar to OECD 404

Applicant's summary and conclusion

Interpretation of results:

other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008.