Docosanamide

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: GLP guideline study. Reliability was changed from "1" to "2" according to the ECHA guidance document "Practical guide 6: How to report read-across and categories".

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

(Z)-docos-13-enamide

EC Number:

204-009-2

EC Name:

(Z)-docos-13-enamide

Cas Number:

112-84-5

Molecular formula:

C22H43NO

IUPAC Name:

docos-13-enamide

Test material form:

other: solid, not further specified

Details on test material:

- Name of test material (as cited in study report): Erucamide
- Substance type: Fatty acid amide
- Physical state: solid
- Analytical purity: approx. 99%
- Storage condition of test material: At ambient temperature in the dark

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: The Broekman Institute, Someren, The Netherlands
- Age at study initiation: approx. 10 weeks
- Weight at study initiation: 2.07 - 2.51 kg
- Housing: Individually in plastic cages with perforated floors.
- Diet: Standard laboratory animal diet (LK-01 and LK-04, diameter 4mm; Hope Farms, Woerden, The Netherlands), 100 g/d
- Water: tap water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-20
- Humidity (%): 50-65
- Air changes (per hr): air conditioned, not further specified
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated contralateral eye served as control

Amount / concentration applied:

60 ± 2 mg (approx. equivalent to 0.1 mL)

Duration of treatment / exposure:

Once, not washed out

Observation period (in vivo):

1, 24, 48, 72 hours and 7 days

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no

SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: pocket flash-light, 2% fluorescein in (adjusted to pH 7.0; 24 hours after instillation)

Each portion of the dispensed amount of test substance was instilled into the conjunctival sac of the left eye of each animal using a spatula. The lids were then held gently together for two seconds and released. The right eye, remaining untreated, served as a control.

Immediately after instillation of the test substance, the animals were observed and abnormalities were recorded. In addition, the eyes were examined approximately 60 minutes, 24, 48 and 72 hours and 7 days after instillation of the test substance. The examinations were performed using a pocket flash-light. Observed local (or systemic) effects other than those covered by the scoring system, were also recorded.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: no effects

Results 2

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: no effects

Results 3

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: no effects

Results 4

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other: no effects

Results 5

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other: no effects

Results 6

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other: no effects

Results 7

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 7 days

Results 8

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 7 days

Results 9

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.67

Max. score:

3

Reversibility:

fully reversible within: 72 hours

Results 10

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.67

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Results 11

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Results 12

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: no effects

Irritant / corrosive response data:

Approximately 60 minutes after exposure two animals showed diffuse conjunctival redness and slight chemosis; the other animal showed slight conjunctival redness and slight chemosis. The conjuctival redness had resolved in one animal by day 3 and in the other two animals between days 3 and 7. The chemosis resolved within 24, 48 or 72 hours for each rabbit separately. Treatment of the eyes with fluorescein 24 hours after exposure revealed no epithelial damage in any of the animals.

Other effects:

No signs of systemic intoxication were observed in any of the rabbits.

Applicant's summary and conclusion

Interpretation of results:

other: CLP criteria not met, no classification required according to Regulation (EC) No 1272/2008

Conclusions:

CLP: not classified
Based on the estimated Draize score of 6 (60 minutes) the test substance should be classified as mildly irritating according to the scheme of kay and Calandra. According to the EEC criteria for classification and labelling of dangerous substances, the test substance need not be labelled as an eye irritant.

Executive summary:

Instillation of approximately 60 mg of the test substance in one of the eyes of each of three albino rabbits resulted in slight to diffuse redness of the conjuctivae and slight chemosis. The conjuctival redness had resolved in one animal by day 3 and in the other two animals between days 3 and 7. The chemosis resolved within 24, 48 or 72 hours for each rabbit separately. Based on the estimated Draize score of 6 (60 minutes) the test substance should be classified as mildly irritating according to the scheme of Kay and Calandra. According to the criteria laid down in Annex I of the Regulation (EC) No 1272/2008, the test substance need not be labelled as an eye irritant.