Fatty acids, C18-unsatd., dimers, hydrogenated

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

29 Feb 1988 - 14 Mar 1988

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP - Guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

Version / remarks:

adopted September, 1984

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Fatty acids, C18-unsatd., dimers, hydrogenated

EC Number:

500-231-1

EC Name:

Fatty acids, C18-unsatd., dimers, hydrogenated

Cas Number:

68783-41-5

Molecular formula:

not applicable (UVCB substance)

IUPAC Name:

10,11-dioctylicosanedioic acid; 8-[2-(7-carboxyheptyl)-5,6-dipentyl-decahydronaphthalen-1-yl]octanoic acid; 9-[6-(8-carboxyoctyl)-2-heptyl-3-pentylcyclohexyl]nonanoic acid

Details on test material:

- Name of test material (as cited in study report): Pripol 1009/Dimer acid
- Physical state: liquid
- Analytical purity: approx. 99 %
- Storage condition of test material: at ambient temperature in the dark

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: The Broekman Institute
- Age at study initiation: 10 to 12 weeks
- Weight at study initiation: 2-4 kg
- Housing: individually in a plastic cage with a perforated floor
- Diet: standard laboratory animal diet restricted to a maximum of 100 g per day
- Water (ad libitum): tap water via automatic nozzles
- Acclimation period: at least five days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-21
- Humidity (%): 50-70
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Vehicle:

not specified

Controls:

other: the untreated eye served as control

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.1 mL

Duration of treatment / exposure:

single instillation without washing

Observation period (in vivo):

14 days. reading tume points: 1, 24, 48, 72 h and 7, 14 days post-instillation

Number of animals or in vitro replicates:

3

Details on study design:

SCORING SYSTEM: draize scores


TOOL USED TO ASSESS SCORE: fluorescein
24 hours after instillation of the test substance (iimediately after scoring the corneal opacity and alterations of iris and conjunctivae), a solution of 2 %fluorescin in water was applied to both eyes of each animal to quantitatively examine the potential for corneal injury.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal: #1, 2, 3 (1 male and 2 female animals)

Time point:

other: mean over 24, 48, 72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

iris score

Basis:

animal: #1, 2, 3 (1 male and 2 female animals)

Time point:

other: mean over 24, 48, 72 h

Score:

0

Max. score:

4

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal #1

Remarks:

(1 male animal)

Time point:

other: mean over 24, 48, 72 h

Score:

1.3

Max. score:

4

Reversibility:

fully reversible within: 14 days

Results 4

Irritation parameter:

conjunctivae score

Basis:

animal #2

Remarks:

(1 female animal)

Time point:

other: mean over 24, 48, 72 h

Score:

1.3

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 5

Irritation parameter:

conjunctivae score

Basis:

animal #3

Remarks:

(1 female animal)

Time point:

other: mean over 24, 48, 72 h

Score:

0.7

Max. score:

4

Reversibility:

fully reversible within: 72 h

Results 6

Irritation parameter:

chemosis score

Basis:

animal: #1, 2, 3 (1 male, 2 female animals)

Time point:

other: mean over 24, 48, 72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 7 days

Irritant / corrosive response data:

Instillation of the test article into one of the eyes of each of three albino rabbits affected the conjunctivae only. Approximately 1 hour after exposure, all three animals showed diffuse redness of the palpebral conjunctivae and slight chemosis. The observed redness had decreased to slight in one female animal within 24 hours and within 48 hours in the other two animals. The chemosis of all three rabbits, which was only observed on the palpebral conjunctivae after the first reading, resolved between days 3 and 7. No adverse effects on the cornea and the iris were observed in any of the rabbits during the entire observation period. Treatment of the eyes with fluorescein did not reveal any corneal epithelial damage.

Other effects:

No signs of systemic intoxication were observed in any of the rabbits.

Any other information on results incl. tables

The authors stated that the test substance should be classified as mildly irritating according ot the scheme of Kay and Calandra.

However, according ot the current DSD and CLP criteria for classification and labelling, the test substance need not be labelled as an eye irritant.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test substance does not fulfil the requirements to be classified according to DSD and CLP criteria for classification and labelling.
DSD: no classification
CLP: no classification