Sorbitan palmitate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Basic data given (occlusive coverage, analytical purity of test substance not specified, 24 hours exposure, no experimental 48 h reading performed).

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1987

Report date:

1987

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

(occlusive coverage, analytical purity of test substance not specified, 24 hours exposure, no experimental 48 h reading performed)

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Sorbitan palmitate

EC Number:

247-568-8

EC Name:

Sorbitan palmitate

Cas Number:

26266-57-9

Molecular formula:

C22H42O6

IUPAC Name:

(2R)-2-[(2R,3R,4S)-3,4-dihydroxyoxolan-2-yl]-2-hydroxyethyl hexadecanoate

Details on test material:

- Name of test material (as cited in study report): palmitate de sorbitan
- Lot/batch No.: 47
- Analytical purity: not specified

Test animals

Species:

rabbit

Strain:

other: New Zealand

Test system

Type of coverage:

occlusive

Preparation of test site:

other: shaved and abraded

Vehicle:

unchanged (no vehicle)

Controls:

other: not required, untreated sites of the same animal served as control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g

Duration of treatment / exposure:

24 h

Observation period:

72 h

Number of animals:

6 males

Details on study design:

SCORING SYSTEM:
comparable to Draize scoring system (only reactions on shaved skin sites considered relevant for interpretation)

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

out of all 6 animals

Time point:

other: mean over 24, 48 and 72 h

Score:

0.45

Max. score:

4

Reversibility:

fully reversible within: 72 h

Results 2

Irritation parameter:

edema score

Basis:

mean

Remarks:

out of all 6 animals

Time point:

other: mean over 24, 48 and 72h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Any other information on results incl. tables

Table 1: Results of skin irritation study

Observation time	Rabbit no.
	1		2		3		4		5		6
	Erythema	Edema	Erythema	Edema	Erythema	Edema	Erythema	Edema	Erythema	Edema	Erythema	Edema
24 h	1	0	0	0	1	0	1	0	1	0	0	0
48 h	No experimental data available; for calculation of mean scores, the 48 h values were assumed to be the same as those at 24 h (worst case assumption)
72 h	0	0	0	0	0	0	0	0	0	0	0	0

Table 2: Calculation of mean scores

Observation time	Rabbit no.
	1		2		3		4		5		6
	Erythema	Edema	Erythema	Edema	Erythema	Edema	Erythema	Edema	Erythema	Edema	Erythema	Edema
Mean value 24 + 48 + 72 h*	0.67	0	0	0	0.67	0	0.67	0	0.67	0	0	0

*No 48 h data are available: for calculation of mean scores, the 48 h values were assumed to be the same as those at 24 h (worst case assumption: persistence of effects seen at 24 h over 48 h).

A mean erythema score of 0.45 and a mean edema score of 0 was calculated for all 6 animals over 24, 48 and 72 h.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

CLP: not classified
DSD: not classified