Reaction mass of Fatty acids, montan-wax and Montan wax

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

25 FEB 1997 to 7 MAR 1997

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study (EU B5/OECD 405)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1997

Report date:

1997

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:

Automatically generated during migration to IUCLID 6, no data available

IUPAC Name:

Automatically generated during migration to IUCLID 6, no data available

Details on test material:

- Name of test material (as cited in study report): Hoechst Wachs E
- Substance type: light yellow substance
- Physical state: solid
- Storage condition of test material: darkness at room temperature in a fume cupboard

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Thomae, Biberach, Germany
- Age at study initiation:
- Weight at study initiation: 2.4-3.1 kg
- Housing: individually
- Diet: ssniff K-H (V2333) ad libitum)
- Water: ad libitum
- Acclimation period: 1 week under study conditions


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 50 +/- 20
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated eye served as control

Amount / concentration applied:

100 mg of test substance

Duration of treatment / exposure:

24 h

Observation period (in vivo):

1, 24, 48 and 72 h

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with isotonic saline at approx. 37 °C
- Time after start of exposure: 24 h, at all other examination time points at which treated eyes showed discharge and after fluorescein treatment


SCORING SYSTEM: according to guidelines


TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24-48-72 h

Score:

0

Max. score:

4

Reversibility:

other: no effects observed

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24-48-72 h

Score:

0

Max. score:

2

Reversibility:

other: no effects observed

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 24-48-72 h

Score:

0.22

Max. score:

3

Reversibility:

fully reversible within: 48 h

Remarks on result:

other: Redness; individual mean scores: 0.00; 0.33; 0.33, the maximum score observed was 1.0

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24-48-72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 24 h

Remarks on result:

other: grade 1 chemosis was observed at 1.1 h post exposure

Other effects:

All 3 animals showed a clear, colourless discharge 1-1.1 h after end of exposure (grade 2, moistening of lids and hairs adjacent to the lids). No discharge was observed at 24 h post exposure.

Any other information on results incl. tables

The maximum conjunctivae score of the 3 tested animals at 1-1.1 h after end of exposure was 1, 2 and 2, respectively. The maximum chemosis score at 1-1.1 h after end of exposure was 1 in all tested animals.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: other: CLP regulation

Conclusions:

The undiluted test substance was not irritating to the eyes of rabbits.

Executive summary:

The undiluted test substance (Hoechst Wachs E) was applicated to the eyes of 3 rabbits and removed 24 h later. The treatment caused a slight, transient reddening of the conjunctiva (mean score for 24-48-72 h: 0.22), but no iris effects, cornea opacity or chemosis. All 3 animals showed a clear, colourless discharge 1.1 h after end of exposure (grade 2, moistening of lids and hairs adjacent to the lids). No discharge was observed at 24 h post exposure.