Mixture of mono-, di- and triesters obtained with isooctadecanoic acid and hydrogenated castor oil

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP-Study according to OECD Guideline.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2004

Report date:

2004

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Salacos HCISV-L

IUPAC Name:

Salacos HCISV-L

Test material form:

semi-solid (amorphous): gel

Remarks:

migrated information: paste

Details on test material:

- Name of test material (as cited in study report): Salacos HCISV-L
- Substance type: organic
- Physical state: liquid
- Analytical purity: not stated
- Lot/batch No.: 40314
- Expiration date of the lot/batch: 02-May-2003
- Stability under test conditions: stable under storage conditions
- Storage condition of test material: in the original container at room temperature (range of 17 - 23 °C) away from direct sunlight

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Elevage Scientifique des Dombes, F-01400 Chatillon sur Chalaronne, France
- Age at study initiation: 11-12 weeks
- Weight at study initiation: 1976 - 2269 g
- Housing: individually
- Diet: standard, ad libitum
- Water: tap water, ad libitum
- Acclimation period: not stated

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 23
- Humidity (%): 20 - 70
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

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

Duration of treatment / exposure:

no rinsing was done,

Observation period (in vivo):

1 h, 24 h, 48 h, 72 h

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
- Time after start of exposure: -

SCORING SYSTEM: according to EEC Commission Directive 92/69/EEC

TOOL USED TO ASSESS SCORE: hand-slit lamp

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Results 2

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Results 3

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

fully reversible

Results 4

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24 h

Score:

1

Max. score:

4

Reversibility:

fully reversible

Results 5

Irritation parameter:

conjunctivae score

Basis:

other: animal #2, #3

Time point:

24 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Results 6

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

48 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Results 7

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Results 8

Irritation parameter:

other: primary Eye Irritation Score

Basis:

mean

Time point:

24/48/72 h

Score:

0.11

Max. score:

13

Reversibility:

fully reversible

Irritant / corrosive response data:

see result table

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Based upon the referred classification, the substance is considered to be not irritating to the rabbit eye

Executive summary:

The primary eye irritation potentail of Salacos HCISV-L was investigated by instillation of 0.1 ml into one eye of each of three young adult New Zealand White rabbits. Scoring of irritation effects was performed approximately 1, 24, 48 and 72 hours after test item application. The scores of each animal at the following reading times (24, 48 and 72 hours) were used in calculating the respective mean values for each type of lesion.

The primary eye irritation score was calculated by totaling the mean cumulative scores at 24, 48 and 72 hours and then dividing the resulting total by the number of data points. The primary eye irritation score was 0.11 (max. 13).

The mean score was calculated across 3 scoring times (24, 48 and 72 hours after instillation) for each animal for corneal opacity, iris, redness and chemosis of the conjunctivae, spearately. The individual mean score for corneal opacity and iris was 0.00 for all three animals. The individual mean scores for the conjunctivae were 0.33, 0.00, and 0.00 for reddening and 0.00, 0.00 and 0.00 for chemosis, respectively.

The instillation of Salacos HCISV-L into the eye resulted in mild, early-onset and transient ocular changes, such as reddening of the conjunctivae and sclear. These effects were reversible and were no longer evident 48 hours after treatment. No abnormal findings were observed in the cornea or iris of any animal at any reading. No corrosion was observed at any of the measuring intervals. No staining of the treated eyes by the test item was observed.

Thus, the test item did not induce significant or irreversible damage ot the rabbit eye.