Fatty acids, tall-oil, reaction products with ethanolamine, ethoxylated

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2001-02-20 to 2001-03-06

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study is regarded as relible without restrictions because it was conducted in compliance with GLP regulation and guideline.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2001

Report date:

2001

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

adopted Feb. 1987

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

as of Jan. 1997

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

61791-19-3

Cas Number:

61791-19-3

IUPAC Name:

61791-19-3

Test material form:

other: liquid

Test animals / tissue source

Species:

rabbit

Strain:

other: Littlerussian - Chbb:HM(SPF)

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Bl Pharma KG, 88397 Biberach
- Age at study initiation: young adult female rabbits
- Weight at study initiation: 2.6 - 3.1 kg b.w.
- Housing: individually in PPO cages (floor area: 2576 sq.cm) with perforated floor
- Diet: ad libitum, pelleted complete rabbit diet "Altromin 2123" from Altromin, D-32791 Lage, Lippe
- Water: free access to bottles with domestic quality drinking water acidified with hydrochloric acid to pH 2.5
- Acclimation period: at least one week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C ± 3 °C
- Humidity (%): 55% ± 15 %
- Air changes: 10 times/ hour
- Photoperiod: 12 hours light and 12 hours darkness, Light was on from 6 a.m. to 6 p.m.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.1 mL

Duration of treatment / exposure:

Single treatment. The eyes of the test animals were not washed out after the application of test item.

Observation period (in vivo):

The eyes were examined at 1, 24, 48 and 72 hour(s) and then at 1 and 2 weeks after the application.

Number of animals or in vitro replicates:

3 female animals

Details on study design:

REMOVAL OF TEST SUBSTANCE
The eyes of the test animals were not washed out after the application of test item.

EXAMINATION OF CORNEAL DAMAGE
After the first 24 hour reading Fluorescein was instilled. After rinsing with 20 ml 0.9% sodium chloride solution the eyes were examined again using UV-light to detect possible corneal damage.

SCORING SYSTEM: The eye irritation scores were evaluated according to the scoring system by Draize (1979) and OECD 405 (24 April 2002)

TOOL USED TO ASSESS SCORE: hand-slit lamp, fluorescein

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

other: 24/48/72 hrs

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 2 weeks

Results 2

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

other: 24/48/72 hrs

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 2 weeks

Results 3

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

other: 24/48/72 hrs

Score:

0.67

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 4

Irritation parameter:

iris score

Basis:

animal #1

Time point:

other: 24/48/72 hrs

Score:

1

Max. score:

2

Reversibility:

fully reversible within: 2 weeks

Results 5

Irritation parameter:

iris score

Basis:

animal #2

Time point:

other: 24/48/72 hrs

Score:

1

Max. score:

2

Reversibility:

fully reversible within: 2 weeks

Results 6

Irritation parameter:

iris score

Basis:

animal #3

Time point:

other: 24/48/72 hrs

Score:

1

Max. score:

2

Reversibility:

fully reversible within: 7 days

Results 7

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal #1

Time point:

other: 24/48/72 hrs

Score:

2

Max. score:

3

Reversibility:

fully reversible within: 2 weeks

Results 8

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal #2

Time point:

other: 24/48/72 hrs

Score:

2

Max. score:

3

Reversibility:

fully reversible within: 2 weeks

Results 9

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal #3

Time point:

other: 24/48/72 hrs

Score:

2.67

Max. score:

3

Reversibility:

fully reversible within: 2 weeks

Results 10

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

other: 24/48/72 hrs

Score:

1.33

Max. score:

4

Reversibility:

fully reversible within: 2 weeks

Results 11

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

other: 24/48/72 hrs

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 2 weeks

Results 12

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

other: 24/48/72 hrs

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 13

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24/48/72 hrs

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 2 weeks

Results 14

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24/48/72 hrs

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 2 weeks

Results 15

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

mean

Time point:

other: 24/48/72 hrs

Score:

2.2

Max. score:

4

Reversibility:

fully reversible within: 2 weeks

Results 16

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24/48/72 hrs

Score:

1.8

Max. score:

4

Reversibility:

fully reversible within: 2 weeks

Irritant / corrosive response data:

One hour after application a scattered or diffuse area of opacity on more than one quarter, but less than half of the cornea, an iris with markedly deepened folds, congestion, swelling, moderate circumcorneal injection and existence of reaction to light were observed in all animals. A diffuse, crimson red conjunctiva with individual vessels not easily discernible, a swelling above normal and a discharge with moistening of the lids and hairs just adjacent to lids were observed in two animals and a discharge different from normal in animal 3.

24 hours after application of the test article a scattered or diffuse area of opacity on more than one quarter, but less than half of the cornea, an iris with markedly deepened folds, congestion, swelling, moderate circumcorneal injection and existence of reaction to light, a diffuse, crimson red conjunctiva with individual vessels not easily discernible, an obvious swelling with partial eversion of lids and a discharge with moistening of the lids and hairs, and considerable area around the eye were observed in all animals.

After instillation of Fluorescein all animals showed a scattered or diffuse area of opacity on more than half, but less than three quarters of the cornea.
48 hours after application of the test article after instillation of Fluorescein two animals showed a scattered or diffuse area of opacity on more than one quarter, but less than half of the cornea, whereas a scattered or diffuse area of opacity on one quarter or less of the cornea was observed in other animal.
72 hours after application of the test article two animals showed a scattered or diffuse area of opacity on more than quarter, but less than half of the cornea, an iris with markedly deepened folds, congestion, swelling, moderate circumcorneal injection and existence of reaction to light, a diffuse, crimson red conjunctiva with individual vessels not easily discernible as well as a swelling above normal.
7 days after application of the test article some conjunctival vessels definitely injectedwere observed in two animals No. 1 and No. 2. Animal No.3 did not show any signs of eye irritation.
14 days after application of the test article animals No. 1 and No. 2 were free of any signs of eye irritation, too.

14 days after application of the test article animals No. 1 and No.2 were free of any signs of eye irritation.

Applicant's summary and conclusion

Interpretation of results:

irritating

Remarks:

Migrated information