Sorbitan, isooctadecanoate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Apr 1977

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Basic data given (no data on test substance purity, no experimental 48 h reading performed, 24 h exposure).

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1977

Report date:

1977

Materials and methods

Test guideline

Test guideline 1

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

(no data on test substance purity, no experimental 48 h reading performed, 24 h exposure)

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: CFR 16, 1500.41

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Sorbitan, isooctadecanoate

EC Number:

276-171-2

EC Name:

Sorbitan, isooctadecanoate

Cas Number:

71902-01-7

Molecular formula:

C23H48O8

IUPAC Name:

2-(3,4-dihydroxyoxolan-2-yl)-2-hydroxyethyl 3-methylheptadecanoate

Details on test material:

- Name of test material (as cited in study report): only trade name given
- Analytical purity: no data

Test animals

Species:

rabbit

Strain:

other: albino rabbit, not further specified

Test system

Type of coverage:

occlusive

Preparation of test site:

other: shaved skin: intact and abraded

Vehicle:

unchanged (no vehicle)

Remarks:

assumption, since according to followed guideline liquids are applied undiluted

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.5 mL

Duration of treatment / exposure:

24 h

Observation period:

72 h
Reading time points immediately after removal of patch (24 h) and 48 h later (72 h)

Number of animals:

6

Details on study design:

TEST SITE
- Area of exposure: 1 square inch
- Type of wrap if used: rubberized cloth

REMOVAL OF TEST SUBSTANCE
- patch removal
- Time after start of exposure: 24 h

SCORING SYSTEM: Draize scoring system

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

out of all 6 animals

Time point:

other: mean out of 24 and 72 h

Score:

1.78

Max. score:

4

Reversibility:

not fully reversible within: 72 h

Remarks on result:

other: 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)

Results 2

Irritation parameter:

edema score

Basis:

mean

Remarks:

out of all 6 animals

Time point:

other: mean out of 24 and 72 h

Score:

0.94

Max. score:

4

Reversibility:

not fully reversible within: 72 h

Remarks on result:

other: 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)

Any other information on results incl. tables

Table 1: Numerical scores awarded to the dermal reactions elicited by the test substance for individual animals.

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	2	1	2	1	2	1	2	1	2	1
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	1	0	2	2	2	2	2	1	1	1	2	1

Table 2: Mean numerical scores awarded to the dermal reactions elicited by the test substance.

	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*	1	0	2	1.33	2	1.33	2	1	1.67	1	2	1

*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).

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