Isooctadecanoic acid, mixed esters with oxybis[propanediol]

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

23 - 26 August 1990

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

Materials and methods

Principles of method if other than guideline:

Modified Draize Testing method (Draize JH et al., J. Pharm. Exp. Ther. 82: 377-390, 1944) as prescribed by the FDA (in The Federal Register 38 No.187 §15000.42, USA)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Isooctadecanoic acid, ester with oxybis[propanediol]

EC Number:

277-361-8

EC Name:

Isooctadecanoic acid, ester with oxybis[propanediol]

Cas Number:

73296-86-3

Molecular formula:

C24H50O7

IUPAC Name:

16-methylheptadecanoic acid; 3-(2,3-dihydroxypropoxy)propane-1,2-diol

Test material form:

liquid

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Hare-Marland, Hewitt, New Jersey, USA
- Age at study initiation: young healthy adults, not further specified
- Weight at study initiation: not specified
- Housing: animals were housed individually, no further information available
- Diet: Purina Lab Rabbit ChowR, ad libitum
- Water: tap water, ad libitum
- Acclimation period: min. 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 30 - 70
- Air changes (per hr): not specified
- Photoperiod (hrs dark / hrs light): 12 / 12

IN-LIFE DATES: 23 - 26 August 1990

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

Observation period (in vivo):

Reading time points: 1, 24, 48 and 72 h

Number of animals or in vitro replicates:

3 males and 3 females

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing: no washing was done

SCORING SYSTEM: Draize scoring system; chemosis score is included in conjunctivae score

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

out of all 6 animals

Time point:

24/48/72 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:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other: reversibility: not applicable

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 48 h

Results 4

Irritation parameter:

conjunctivae score

Basis:

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

Time point:

24/48/72 h

Score:

0

Max. score:

3

Reversibility:

other: reversibility: not applicable

Results 5

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 72 h

Results 6

Irritation parameter:

chemosis score

Basis:

animal: #1, #2, #5 and #6

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Results 7

Irritation parameter:

chemosis score

Basis:

animal: #3 and #4

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 h

Irritant / corrosive response data:

An animal exhibited a positive reaction when the test substance produced one or more of the following signs: ulceration of the cornea (other than a fine stippling), opacity of the cornea (other than a slight dulling of the normal luster), inflammation of the iris (other than a slight deepening of the rugae or a light hyperemia of the circumcorneal blood vessels), or an obvious swelling in the conjunctivae (excluding the cornea and iris) with partial eversion of the eyelids and a diffuse crimson color with individual vessels not easily discernible.

Positive ocular scores were observed in two animals during the study at the 1 h observation period. One positive ocular score was seen at the 24 h observation period. Dulling of the cornea was observed in two animals at the 1 and 24 h observation periods. Moderate ocular discharge was observed at the 1h observation period. All scores returned to normal at the 72 h observation period and the study was terminated.

Any other information on results incl. tables

The detailed scores observed are summaries in the following table:

Table 1: Draize scores 

Rabbit no. / sex	Observation	1 h	24 h	48 h	72 h
#1 / m	Cornea Iris Conjunctivae	0 0 1, 1	0 0 1, 0	0 0 0, 0	0 0 0, 0
#2 / m	Cornea Iris Conjunctivae	0 0 1, 2	0 0 0, 0	0 0 0, 0	0 0 0, 0
#3 / m	Cornea Iris Conjunctivae	0 0 1, 1	0 0 2, 1	0 0 1, 0	0 0 0, 0
#4 / f	Cornea Iris Conjunctivae	0* 0 1, 1	0* 0 0, 1	0 0 0, 0	0 0 0, 0
#5 / f	Cornea Iris Conjunctivae	0* 0 1, 2	0* 0 0, 0	0 0 0, 0	0 0 0, 0
#6 / f	Cornea Iris Conjunctivae	0 0 1, 1	0 0 0, 0	0 0 0, 0	0 0 0, 0

*: Slight dulling of the cornea, not leading to a score

Cornea: degree

Iris: degree of iritis

Conjunctivae = redness, chemosis

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.