Amides, C18-unsatd., N,N-bis(hydroxyethyl)

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1976

Report date:

1976

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Title 21, Code of Federal Regulations, 191.11.

Deviations:

no

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

(9Z)-N,N-bis(2-hydroxyethyl)octadec-9-enamide

EC Number:

700-972-2

Molecular formula:

C22H43NO3

IUPAC Name:

(9Z)-N,N-bis(2-hydroxyethyl)octadec-9-enamide

Test material form:

not specified

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL or 0.1 g of the undiluted test substance was instilled into one eye of each rabbit. The other eye served as control.
- Concentration (if solution): 100% (undiluted)

Duration of treatment / exposure:

Single instillation

Observation period (in vivo):

24, 48, 72 h and 7 and 14 d.

Number of animals or in vitro replicates:

Six

Details on study design:

0.1 mL or 0.1 g of the undiluted test substance was instilled into the one eye of each animal, and the other eye served as control. The eyes were evaluated for damage to cornea, iris and bulbar and palpebral conjunctivae at 24, 48 and 72 h and 7 and 14 d after instillation. Any residue of the test substance and accumulated discharge are flushed from the eye each time they are scored.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal: 1 to 6

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other: not applicable

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

iris score

Basis:

animal: 1 to 6

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other: not applicable

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

chemosis score

Basis:

animal: 1 to 6

Time point:

24/48/72 h

Score:

>= 1 - <= 2

Max. score:

2

Reversibility:

not fully reversible within: 14 d

Results 4

Irritation parameter:

conjunctivae score

Remarks:

Redness

Basis:

animal: 1 to 6

Time point:

24/48/72 h

Score:

>= 1 - <= 2

Max. score:

2

Reversibility:

not fully reversible within: 14 d

Remarks on result:

positive indication of irritation

Results 5

Irritation parameter:

overall irritation score

Remarks:

Undiluled test substance

Basis:

animal: 1 to 6

Time point:

24 h

Score:

11.33

Reversibility:

not fully reversible within: 14 d

Results 6

Irritation parameter:

overall irritation score

Remarks:

Undiluted test substance

Basis:

animal: 1 to 6

Time point:

48 h

Score:

7.67

Reversibility:

not fully reversible within: 14 d

Results 7

Irritation parameter:

overall irritation score

Remarks:

Undiluted test substance

Basis:

animal: 1 to 6

Time point:

72 h

Score:

5.67

Reversibility:

not fully reversible within: 14 d

Results 8

Irritation parameter:

overall irritation score

Remarks:

Undiluted test substance

Basis:

animal: 1 to 6

Time point:

7 d

Score:

3.33

Reversibility:

not fully reversible within: 14 d

Results 9

Irritation parameter:

overall irritation score

Remarks:

Undiluted test substance

Basis:

animal: 1 to 6

Time point:

14 d

Score:

2.33

Reversibility:

not fully reversible within: 14 d

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritating to eyes) based on GHS criteria

Conclusions:

Under the study conditions, the undiluted test substance was irritating to eyes.

Executive summary:

The ocular irritation potential of the test substance, C18-unsatd. DEA, was investigated using New Zealand White rabbits in accordance with Title 21, Code of Federal Regulations, 191.11. Undiluted substance (0.1 mL or 0.1 g) was instilled into one eye of each of six rabbits; the other eye served as control. The eyes were evaluated for damage to cornea, iris and conjunctivae at 24, 48, 72 h, then 7 and 14 d. Irritation response in the conjunctiva was observed in terms of redness, chemosis and discharge. The mean conjunctival redness score was 2 in 4/6 animals. The mean irritation score of 11.33, 7.67, 5.67, 3.33 and 2.33 was observed after 24, 48 and 72 h, then 7 and 14 d. Except for conjunctival redness, which was the most prominent response and was present in 3/6 animals, irritation in the remaining eye (chemosis and discharge) reduced to almost 0 by Day 14. Under the study conditions, the test substance was irritating to eyes (Casey, 1976).