Isononyl alcohol

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1986.04.22 - 1986.05.13

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Well documented study essentially undertaken to standard eye irritation guidelines, although not to GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

Report date:

1986

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Isononyl alcohol

EC Number:

248-471-3

EC Name:

Isononyl alcohol

Cas Number:

27458-94-2

Molecular formula:

C9H20O

IUPAC Name:

3,5,5-trimethylhexan-1-ol

Details on test material:

- Name of test material (as cited in study report): Isononanol
- Physical state: liquid
- Analytical purity: >99%
- Sample-No.: 3635-81058

Test animals / tissue source

Species:

rabbit

Strain:

other: Kleine weisse Russen, Chbb-SPF

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Fa. Dr. Karl Thomae GmbH, Biberbach
- Weight at study initiation: 2.2 - 3.0 Kg
- Housing: separately in stainless cages
- Diet (e.g. ad libitum): K4 Alleindiät für Kaninchen, Ssniff Spezialfutter GmbH, 4770 Soest, ad libitum
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C +- 1°C
- Humidity (%): 60% +- 5%
- Air changes (per hr): 15 times / hour
- Photoperiod (hrs dark / hrs light): 12 hrs dark/ 12 hrs light

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1cm³ into the right eye. Left eye acted as an untreated control

Duration of treatment / exposure:

72 hours.

Observation period (in vivo):

21 days

Number of animals or in vitro replicates:

3 animals

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): after 72 hours the treated eye was washed with warm physiological saline (NaCl-solution)

SCORING SYSTEM:
- In according to Draize (Appraisals of the Safety of chemicals in Foods, Drugs and Cosmetics, FDA, Austin 1, Texas 1959 (page 51).

TOOL USED TO ASSESS SCORE:
- hand-slit lamp and "Na-Fluorescein"-Solution

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

other: 24, 48 and 72 hours

Score:

2

Max. score:

2

Reversibility:

fully reversible within: 6 days

Results 2

Irritation parameter:

iris score

Basis:

animal #1

Time point:

other: 24, 48 and 72 hrs

Score:

0.67

Max. score:

1

Reversibility:

fully reversible within: 6 days

Remarks on result:

other: Iris reddened at 24 and 48 hrs

Results 3

Irritation parameter:

conjunctivae score

Remarks:

(conjunctival redness)

Basis:

animal #1

Time point:

other: 24, 48 and 72 hrs

Score:

2.67

Max. score:

3

Reversibility:

fully reversible within: 10 days

Results 4

Irritation parameter:

chemosis score

Remarks:

(conjunctival oedema)

Basis:

animal #1

Time point:

other: 24, 48 and 72 hrs

Score:

1

Max. score:

2

Reversibility:

fully reversible

Results 5

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

other: 24, 48 and 72 hrs

Score:

1.67

Max. score:

2

Reversibility:

not fully reversible within: 21 days

Remarks on result:

other: Easily discernible opacity continued to Day 21

Results 6

Irritation parameter:

iris score

Basis:

animal #2

Time point:

other: 24, 48 and 72 hrs

Score:

0.33

Max. score:

1

Reversibility:

not fully reversible within: 21 days

Remarks on result:

other: Iris partly reddened at 24 hrs, white line on pupil Day 6 to 10 and circumcorneal injection to Day 21

Results 7

Irritation parameter:

conjunctivae score

Remarks:

(conjuntival redness)

Basis:

animal #2

Time point:

other: 24, 48 and 72 hrs

Score:

2.67

Max. score:

3

Reversibility:

fully reversible within: 21 days

Results 8

Irritation parameter:

chemosis score

Remarks:

(conjunctival oedema)

Basis:

animal #2

Time point:

other: 24, 48 and 72 hrs

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 6 days

Results 9

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

other: 24, 48 and 72 hrs

Score:

1.67

Max. score:

2

Reversibility:

fully reversible within: 6 days

Results 10

Irritation parameter:

iris score

Basis:

animal #3

Time point:

other: 24, 48 and 72 hrs

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 14 days

Remarks on result:

other: Iris reddened at 24, 48 and 72 hrs, partly reddened with circumcorneal injection Days 6-10

Results 11

Irritation parameter:

conjunctivae score

Remarks:

(conjunctival redness)

Basis:

animal #3

Time point:

other: 24, 48 and 72 hrs

Score:

3

Max. score:

3

Reversibility:

fully reversible within: 14 days

Results 12

Irritation parameter:

chemosis score

Remarks:

(conjunctival oedema)

Basis:

animal #3

Time point:

other: 24, 48 and 72 hrs

Score:

1.33

Max. score:

2

Reversibility:

fully reversible within: 6 days

Applicant's summary and conclusion

Interpretation of results:

Category 1 (irreversible effects on the eye)

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Isononanol caused serious damage to the eye.

Executive summary:

Isononanol (0.1 ml) was instilled into the right eye of three rabbits. Responses to treatment were assessed using the Draize method 1, 24, 48 and 72 hrs after instillation and again on Days 6, 8, 10, 14, 17 and 21. Easily discernible areas of corneal opacity, reddening of the iris and diffuse beefy-red and slight or obvious swelling of the conjunctivae were observed amonst all three animals.. Corneal opacity and reddening of the iris persisted in one animal on Day 21.