Reaction products resulting from the esterification of Sorbitol with C8 – 18 (even) and C18 unsaturated fatty acids in the ratio of 1:1

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:

other: Basic data given (no data on test substance purity, test material applied as 10% solution)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1983

Report date:

1983

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

(6 animals used, test substance applied as 10% solution, no data on test substance purity)

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Sorbitan laurate

EC Number:

215-663-3

EC Name:

Sorbitan laurate

Cas Number:

1338-39-2

Molecular formula:

C18H34O6

IUPAC Name:

1,4-anhydro-6-O-dodecanoyl-D-glucitol

Constituent 2

Reference substance name:

Reaction products resulting from the esterification of Sorbitol with C8 – 18 (even) and C18 unsaturated fatty acids in the ratio of 1:1

EC Number:

931-434-7

Cas Number:

1338-39-2

Molecular formula:

Molecular formula cannot be given as substance is a mixture.

IUPAC Name:

Reaction products resulting from the esterification of Sorbitol with C8 – 18 (even) and C18 unsaturated fatty acids in the ratio of 1:1

Details on test material:

- Physical state: clear yellow liquid with slightly sweet odor
- Lot/batch No.: Lot 202

Note: Due to analytical test results the substance is defined as UVCB. For further details see IUCLID Chapter 1.2.

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 4 kg (mean)
- Diet: rabbit Altromin 2023 diet, ad libitum
- Water: ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C ± 3°C
- Humidity (%): 50%
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:

water

Controls:

other: the untreated eye served as control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): 10 % (g/g)

Duration of treatment / exposure:

single application

Observation period (in vivo):

72 h (all irritation reactions were reversible within 48 h after treatment)
reading time points: 1, 24, 48 and 72 h

Number of animals or in vitro replicates:

6

Details on study design:

SCORING SYSTEM: Draize Scoring System

TOOL USED TO ASSESS SCORE: macroscopic

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

out of all 6 animals

Time point:

other: mean over 24, 48 and 72 hours

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Results 2

Irritation parameter:

iris score

Basis:

mean

Remarks:

out of all 6 animals

Time point:

other: mean over 24, 48 and 72 hours

Score:

0

Max. score:

2

Reversibility:

other: reversibility: not applicable

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

out of all 6 animals

Time point:

other: mean over 24, 48 and 72 hours

Score:

0.17

Max. score:

3

Reversibility:

fully reversible within: 36 hours

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

out of all 6 animals

Time point:

other: mean over 24, 48 and 72 hours

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Irritant / corrosive response data:

The test material did not induce any changes to iris and cornea of test animals. Conjunctivae of test animals showed a slight erythema 1 hour after application. All effects were fully reversible within 48 hours.

Other effects:

4 animals showed a slight exsudation 1 hour after application which was fully reversible within 24 hours.

Any other information on results incl. tables

Table 1. Results of eye irritation study.
Rabbit #	Time [h]	conjunctivae		iris	cornea		conjunctivae		iris	cornea
		redness	swelling				redness	swelling
1	1	2	0	0	0
	24	1	0	0	0
	48	0	0	0	0
	72	0	0	0	0
	average	0.3	0	0	0	Time to reversion	48	0	0	0
2	1	2	0	0	0
	24	0	0	0	0
	48	0	0	0	0
	72	0	0	0	0
	average	0	0	0	0	Time to reversion	24	0	0	0
3	1	2	1	0	0
	24	1	0	0	0
	48	0	0	0	0
	72	0	0	0	0
	average	0.3	0	0	0	Time to reversion	48	24	0	0
4	1	1	0	0	0
	24	0	0	0	0
	48	0	0	0	0
	72	0	0	0	0
	average	0	0	0	0	Time to reversion	24	0	0	0
5	1	2	0	0	0
	24	1	0	0	0
	48	0	0	0	0
	72	0	0	0	0
	average	0.3	0	0	0	Time to reversion	48	0	0	0
6	1	1	0	0	0
	24	0	0	0	0
	48	0	0	0	0
	72	0	0	0	0
	average	0	0	0	0	Time to reversion	24	0	0	0
	Time [h]	conjunctivae		iris	cornea
		redness	swelling			avg. time to reversion	36	4	0	0
average score	1	1.67	0.17	0	0
	24	0.50	0	0	0
	48	0	0	0	0
	72	0	0	0	0
	24+48+72	0.17	0	0	0

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

DSD: not classified
CLP: not classified