Fatty acids, C16-18, 2-hydroxyethyl esters

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

05 Jun 1991 - 08 Jun 1991

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Comparable to guideline study with acceptable restrictions. Only 72 h observation period, analytical purity of test substance not clearly specified.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1991

Report date:

1991

Materials and methods

Test guideline

Test guideline 1

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

analytical purity of test substance not clearly specified; observation period terminated at 72 h, although not fully reversible at that point

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: FHSA/CPSC: Federal Hazardous Substances Control Act, 16 CFR 1500.42

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Ethylene distearate

EC Number:

211-014-3

EC Name:

Ethylene distearate

Cas Number:

627-83-8

Molecular formula:

C38H74O4

IUPAC Name:

ethylene distearate

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Davidson's Mill Farm, S. Brunswick, NJ, USA
- Housing: individually in suspended stainless steel caging with mesh floors.
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 34 or 51 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.5 - 21.5

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: the untreated eye served as control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g

Duration of treatment / exposure:

72 h

Observation period (in vivo):

72 h
Reading time points: 24, 48 and 72 h

Number of animals or in vitro replicates:

3 males and 3 females

Details on study design:

SCORING SYSTEM: Draize scoring system

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 h

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 h

Score:

0

Max. score:

2

Reversibility:

other: reversibility: not applicable

Results 3

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

other: mean over 24, 48 and 72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 h

Results 4

Irritation parameter:

chemosis score

Basis:

animal: #2, #3, #4, #5 and #6

Time point:

other: mean over 24, 48 and 72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Results 5

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

other: mean over 24, 48 and 72 h

Score:

1

Max. score:

3

Reversibility:

not fully reversible within: 72 h

Results 6

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

other: mean over 24, 48 and 72 h

Score:

0.66

Max. score:

3

Reversibility:

fully reversible within: 72 h

Results 7

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

other: mean over 24, 48 and 72 h

Score:

1.33

Max. score:

3

Reversibility:

not fully reversible within: 72 h

Results 8

Irritation parameter:

conjunctivae score

Basis:

animal #4

Time point:

other: mean over 24, 48 and 72 h

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 48 h

Results 9

Irritation parameter:

conjunctivae score

Basis:

animal #5

Time point:

other: mean over 24, 48 and 72 h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 72 h

Results 10

Irritation parameter:

conjunctivae score

Basis:

animal #6

Time point:

other: mean over 24, 48 and 72 h

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 48 h

Irritant / corrosive response data:

The test substance has slight irritaing effects when instilled into rabbit eyes. At the end of the observation period slight hyperemia in 2 animals was left.

Other effects:

All animals appeared active and healthy. Apart from the eye irritation noted in Table 1, there were no signs of systemic toxicity, adverse pharmacologic effects or abnormal behavior.

Any other information on results incl. tables

Table1: Individual eye irritation scores

	Average irritation score of 24, 48 and 72 h
Animal number	Cornea	Iris	Conjunctiva	Chemosis
8797	0	0	1	0.33
8798	0	0	0.66	0
8799	0	0	1.33	0
8800	0	0	0.33	0
8801	0	0	1	0
8802	0	0	0.33	0
Mean	0	0	0.775	0.055

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