N,N-bis(2-hydroxyethyl)dodecanamide

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

October 31, 1986 to November 25, 1986

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1987

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

not specified

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Deviations:

not specified

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Amides, C12-18(even-numbered) and C18(unsatd.), N,N-bis(hydroxyethyl)

EC Number:

931-335-9

Molecular formula:

not applicable

IUPAC Name:

Amides, C12-18(even-numbered) and C18(unsatd.), N,N-bis(hydroxyethyl)

Test material form:

not specified

Test animals / tissue source

Species:

rabbit

Strain:

other: Kleinrusse chbb

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- 4 males
- Source: HM/Fa. Thomae, Germany
- Average bodyweight at test start: 2,630 g

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

0.01 ml (low volume method)

Duration of treatment / exposure:

Single treatment

Observation period (in vivo):

21 d

Number of animals or in vitro replicates:

4

Details on study design:

0.01 mL test substance carefully applied in undiluted form into the lower lid of the right eye of the test animals. The other eye remained untreated. After 1, 6, 24, 48 and 72 h, then 7, 10, 14, 17 and 21 d, eyes were analysed for reaction based on the Draize appraisal method (J.H. Draize, Appraisal of the safety of chemicals in foods, drugs and cosmetics. Ass. of Food and Drug Officials of the US, pp 49-52 (1959)).

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

other: Redness, chemosis, and/or exudation

Basis:

other: moderate to severe redness, chemosis, and/or exudation

Time point:

72 h

Reversibility:

not fully reversible within: 21 d

Remarks on result:

probability of severe irritation

Results 2

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

ca. 1.25

Max. score:

4

Reversibility:

not fully reversible within: 21 days

Remarks on result:

positive indication of irritation

Results 3

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

ca. 0.25

Max. score:

2

Reversibility:

not fully reversible within: 21 days

Remarks on result:

positive indication of irritation

Results 4

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

mean

Time point:

24/48/72 h

Score:

ca. 2.58

Max. score:

3

Reversibility:

not fully reversible within: 21 days

Remarks on result:

positive indication of irritation

Results 5

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

ca. 1.17

Max. score:

4

Reversibility:

not fully reversible within: 21 days

Remarks on result:

positive indication of irritation

Results 6

Irritation parameter:

conjunctivae score

Remarks:

Discharge

Basis:

mean

Time point:

24/48/72 h

Score:

ca. 2.92

Max. score:

3

Reversibility:

not fully reversible within: 21 days

Remarks on result:

positive indication of irritation

Irritant / corrosive response data:

On the cornea, slight to moderate opacity was observed in all treated eyes. The reaction was irreversible. Irreversible effects were also noted in the iris of one animal. Finally, all animals presented moderate to severe redness, chemosis, and/or exudation (sometimes infiltrated with blood) of the conjunctivae, which did not entirely disappear by the end of the 21 d observation period.

Any other information on results incl. tables

None.

Applicant's summary and conclusion

Interpretation of results:

Category 1 (irreversible effects on the eye) based on GHS criteria

Conclusions:

Under the study conditions, the test substance was highly irritating to the rabbit eye.

Executive summary:

A study was performed to assess the eye irritation potential of the test substance, C12 -18 and C18 -unsatd. DEA, according to OECD Guideline 405 and EU Method B.5, in compliance with GLP. Four rabbits received 0.01 mL of an undiluted solution in one eye. The other eye remained untreated. After 1, 6, 24, 48 and 72 h, then 7, 10, 14, 17 and 21 d, eyes were analysed for reaction based on the Draize scoring method. On the cornea, slight to moderate opacity was observed in all treated eyes. The reaction was irreversible. Irreversible effects were also noted in the iris of one animal. Finally, all animals presented moderate to severe redness, chemosis, and/or exudation (sometimes infiltrated with blood) of the conjunctivae, which did not entirely disappear by the end of the 21 d observation period. Under the study conditions, the test substance produced irreversible damage to the rabbit eye (Kästner, 1987).