Castor oil, ester with glycerol

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Remarks:

no information on test substance purity

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1972

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

The test was performed as laid down in the F.D.A. Handbook, Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics, F.D.A. (1959), p. 47.
- Principle of test: A 0.5 mL sample of the test material was applied to clipped areas of both intact and abraded skin of four New Zealand White rabbits under occlusive conditions for 24 h.
- Parameters analysed / observed: Skin reaction according to Draize scale was measured immediately and 48 h after patch removal.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Castor oil, ester with glycerol

EC Number:

270-616-4

EC Name:

Castor oil, ester with glycerol

Cas Number:

68459-67-6

Molecular formula:

not applicable, substance is UVCB

IUPAC Name:

Castor oil, ester with glycerol

Test animals

Species:

rabbit

Strain:

New Zealand White

Test system

Type of coverage:

occlusive

Preparation of test site:

clipped

Remarks:

One side of each back was additionally abraded with a suitable abrading tool, the other back side was left intact.

Vehicle:

unchanged (no vehicle)

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.5 mL

Duration of treatment / exposure:

24 h

Observation period:

48 h after patch removal
Reading time points: 0 and 48 h after patch removal

Number of animals:

4

Details on study design:

TEST SITE
- Area of exposure: animals back
- Type of wrap if used: One inch gauze pads were secured with adhesive tape and further occluded with a stockinette sleeve covering the entire trunk of the animal.

SCORING SYSTEM:
- Method of calculation: Draize scoring system

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal: #1 and #3

Remarks:

intact skin side

Time point:

other: 0 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 48 h

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Remarks:

intact skin side

Time point:

other: 0 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Results 3

Irritation parameter:

erythema score

Basis:

animal #4

Remarks:

intact skin side

Time point:

other: 0 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 48 h

Results 4

Irritation parameter:

erythema score

Basis:

mean

Remarks:

of all 4 animals; intact skin sides

Time point:

48 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Results 5

Irritation parameter:

edema score

Basis:

mean

Remarks:

of all 4 animals; intact skin sides

Time point:

other: 0 and 48 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Irritant / corrosive response data:

On intact skin, slight to well defined erythema (grade 1-2) was apparent in three rabbits immediately after patch removal. This irritation was reversible within 48 h after patch removal. No edema was observed in any animal at any reading time point.

Any other information on results incl. tables

Table 1. Results of skin irritation test on intact and abraided skin.

Observation time	Intact skin
	Rabbit no.
	1		2		3		4
	Erythema	Edema	Erythema	Edema	Erythema	Edema	Erythema	Edema
0 h	1	0	0	0	1	0	2	0
48 h	0	0	0	0	0	0	0	0
	Abraded skin
0 h	1	0	0	0	1	0	2	0
48 h	1	0	0	0	0	0	2	1

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

Conclusions:

Under the conditions of this skin irritation study in rabbits the undiluted test substance was not irritating to the skin.