Castor oil, ester with glycerol

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:

comparable to guideline study with acceptable restrictions

Remarks:

no information on purity of test substance given; limited documentation; scoring of conjunctivae as redness, chemosis and discharge in combined score only

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1972

Materials and methods

Test guideline

Test guideline 1

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

02 Oct 2012

Deviations:

yes

Remarks:

limited documentation; scoring of conjunctivae as redness, chemosis and discharge in combined score only

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: F.D.A. Handbook, Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics, F.D.A. (1959), p. 47.

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 / tissue source

Species:

rabbit

Strain:

New Zealand White

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.1 mL

Duration of treatment / exposure:

single application without washing, 2 and 4 sec

Observation period (in vivo):

7 days
Reading time points: 1, 2, 3, 4 and 7 days

Number of animals or in vitro replicates:

3 per group (no washing, 2 and 4 sec exposure)

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing: Treated eyes where washed with 20 mL lukewarm water.
- Time after start of exposure: 2 or 4 sec

SCORING SYSTEM: Draize scoring system; scoring of conjunctivae as redness, chemosis and discharge was given in combined score only (Scores of Redness + Chemosis + Discharge) x 2 = 20 (Maximum score)

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

of 3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Remarks on result:

other: treated eye not washed

Results 2

Irritation parameter:

iris score

Basis:

mean

Remarks:

of 3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other: not applicable

Remarks on result:

other: treated eye not washed

Results 3

Irritation parameter:

conjunctivae score

Remarks:

scoring of conjunctivae as redness, chemosis and discharge in combined score only

Basis:

animal #1

Time point:

24/48/72 h

Score:

1.33

Max. score:

20

Reversibility:

fully reversible within: 48 h

Remarks on result:

other: treated eye not washed

Results 4

Irritation parameter:

conjunctivae score

Remarks:

scoring of conjunctivae as redness, chemosis and discharge in combined score only

Basis:

animal #2

Time point:

24/48/72 h

Score:

1.33

Max. score:

20

Reversibility:

fully reversible within: 48h

Remarks on result:

other: treated eye not washed

Results 5

Irritation parameter:

conjunctivae score

Remarks:

scoring of conjunctivae as redness, chemosis and discharge in combined score only

Basis:

animal #3

Time point:

24/48/72 h

Score:

2

Max. score:

20

Reversibility:

fully reversible within: 48 h

Remarks on result:

other: treated eye not washed

Results 6

Irritation parameter:

chemosis score

Remarks on result:

not measured/tested

Irritant / corrosive response data:

The test substance produced mild conjunctival irritation (total conjunctivae score 4 and 6) 24 h after instillation without washing in all 3 rabbits. This conjunctival irritation was reversible within 48 h.
In rabbits in which the treated eyes were washed after 2 or 4 sec no irritation was observed at any observation time point.

Any other information on results incl. tables

Table 1: Results of Draize test in unwashed eye

Alteration	Animal No.	Time (h)
		24	48	72	mean 24/48/72 h	reversible within
Cornea	1	0	0	0	0	0
	2	0	0	0	0	0
	3	0	0	0	0	0
Iris	1	0	0	0	0	0
	2	0	0	0	0	0
	3	0	0	0	0	0
Conjunctivae Redness + Chemosis + Discharge *	1	4	0	0	0	0
	2	4	0	0	0	0
	3	6	0	0	0	0

 * Combined scores only; (Scores of redness + chemosis + discharge) x 2 = 20 (maximum score)

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 eye irritation study in rabbits the test substance was not irritating to the eye.