Alcohols, C11-15-secondary, ethoxylated

Eye irritation

Administrative data

Endpoint:

eye irritation, other

Remarks:

An in vivo (already existing) study is available)

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study conducted according to internationally accepted guidelines and to GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1996

Report date:

1996

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:

EPA OTS 798.4500 (Acute Eye Irritation)

Test guideline 3

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:

Alcohols, secondary C11-15, ethoxylated

EC Number:

614-295-4

Cas Number:

68131-40-8

Molecular formula:

C(11-15) H(23-31) O (C2H4O)xH where n= approximately 3

IUPAC Name:

Alcohols, secondary C11-15, ethoxylated

Details on test material:

- Name of test material (as cited in study report): softanol 30

- Substance type: organic
- Physical state: colourless to slightly yellow liquid
- Analytical purity: >99% by wt

- Lot/batch No.: W60130
- Expiration date of the lot/batch: August 31, 1996

- Stability under test conditions: stable at storage conditions
- Storage condition of test material: at room temperature (ca. 20°C), away from sunlight
- Other:

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Dr. Karl Tomae GmbH
- Age at study initiation: 14-15 weeks
- Weight at study initiation: male: 2.7kg; fem 2.6-2.8 kg
- Housing: individually in stainless steel cages with an automatic cleaning system, equipped with feed hoppers, drinking water bowls and wood for gnawing.
- Diet (e.g. ad libitum): Pelleted standard Kliba 341 rabbit maintenance diet (batch 93/96) ad libitum from Kliba Muhlen AG, CH-4303 Kaiseraugst). Results of analysis for contaminants are included in this report.
- Water (e.g. ad libitum): Community tap water from Itingen, ad libitum.
- Acclimation period: four days under laboratory conditions after health examination. Only healthy animals were used for the study.


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20+/-3°C
- Humidity (%): 40-70%
- Air changes (per hr): 10 to 15 per hour
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: April 10, 1996 To: April 18, 1996

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: Each animal was only treated in left eye. The right eye was left untreated to act as control.

Amount / concentration applied:

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

Duration of treatment / exposure:

once

Observation period (in vivo):

1, 24, 48 and 72 hours after administration

Number of animals or in vitro replicates:

1 male, 2 females

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): none



SCORING SYSTEM:

CORNEA
Opacity: degree of density (densest area used for assessment)
No ulceration or opacity,0;
Scattered or diffuse areas of opacity (other than slight dulling of normal luster), details of iris clearly visible, 1 *;
Easily discernible translucent area, details of iris slightly obscured, 2 *;
Nacrous area, no details of iris visible, size of pupil barely discernible, 3*;
Opaque cornea, iris not discernible through the opacity, 4*.

IRIS
Normal, 0;
Markedly deepened rugae, congestion, swelling, moderate circumcorneal hyperemia, or injection, any of these or combination thereof, iris still reacting to light (sluggish reaction is positive), 1 *;
No reaction to light, hemorrhage, gross destruction (any or all of these), 2 *

CONJUNCTIVE REDNESS (refers to palpebral and bulbar conjunctivae, excluding cornea and iris).
Blood vessels normal, 0;
Some blood vessels definitely hyperaemic (injected), 1;
Diffuse, crimson colour, individual vessels not easily discernible, 2;
diffuse beefy red, 3.

CHEMOSIS: lids and/or nictitating membranes
No swelling, 0;
Any swelling above normal (includes nictitating membranes), 1;
Obvious swelling with partial eversion of lids, 2;
swelling with lids about half closed, 3;
swelling with lids more than half closed, 4.

Maximum scores: Cornea: 4; Iris: 2; Conjunctival Redness:3; Conjunctival Chemosis:4
Maximum attainable score: 13
When present, corrosion of and/or staining of sclera and cornea by the test article were recorded and reported.

TOOL USED TO ASSESS SCORE: Eye examination were made with a Varta Cliptrix diagnostic lamp

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

other: 24h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

other: 24h

Score:

0

Max. score:

4

Results 3

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

other: 24h

Score:

0

Max. score:

4

Results 4

Irritation parameter:

iris score

Basis:

animal #1

Time point:

other: 24h

Score:

0

Max. score:

2

Results 5

Irritation parameter:

iris score

Basis:

animal #2

Time point:

other: 24h

Score:

0

Max. score:

2

Results 6

Irritation parameter:

iris score

Basis:

animal #3

Time point:

other: 24h

Score:

0

Max. score:

2

Results 7

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

other: 24h

Score:

0

Max. score:

3

Results 8

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

other: 24h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 48h

Results 9

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

other: 24h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 48h

Results 10

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

other: 24h

Score:

0

Max. score:

4

Results 11

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

other: 24h

Score:

0

Max. score:

4

Results 12

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

other: 24h

Score:

0

Max. score:

4

Irritant / corrosive response data:

Softanol 30 showed a primary irritation score of 0.22 when applied to the conjuctival sac of the rabbit eye. No corrosion of the cornea was observed at any of the reading times.

Other effects:

No clinical signs of systemic toxicity were observed in the animals during the test and observation period, and no mortality occurred. Based upon the referred classification criteria the test article SOFTANOL 30 is classified as 'not irritating" to the eye.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: OECD GHS

Conclusions:

Based upon the GHS classification criteria the test article SOFTANOL 30 is Classified as 'not irritating" to the eye.

Executive summary:

In a primary eye irritation study realised according to the OECD guideline 405 and in compliance with GLP, 0.1ml of undiluted Softanol 30 was instilled into the conjunctival sac of left eye (right remained as control) of New Zealand rabbits (1 male, 2 females) for 1, 24, 48 and 72 hours (RCC 1996, report 622438). Eyes were not washed and animals then were observed for irritation at 1, 224, 48 and 72 hours. 

Softanol 30 showed a primary irritation score of 0.22 when applied to the conjuctival sac of the rabbit eye. No corrosion of the cornea was observed at any of the reading times.

Based upon the GHS classification criteria the test article SOFTANOL 30 is Classified as 'not irritating" to the eye.