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Toxicological information

Eye irritation

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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

Constituent 1
Chemical structure
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

Resultsopen allclose all
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
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
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
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
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 72 h
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
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.