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

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From February 16, 1988 to March 09, 1988

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Amides, C8-18 (even numbered) and C18-unsatd., N-(hydroxyethyl)

EC Number:

931-330-1

IUPAC Name:

Amides, C8-18 (even numbered) and C18-unsatd., N-(hydroxyethyl)

Test material form:

solid

Test animals / tissue source

Species:

rabbit

Strain:

other: Small White Russian

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Dr. Karl Thomae GmbH, Biberach, Germany
- Weight at study initiation: 2.4 - 32.5 kg
- Housing: wire mesh cages, one animal/cage
- Diet (e.g. ad libitum): K4 diet for rabbits, Ssniff Special diet GmbH, Soest, Germany
- Water (e.g. ad libitum): tap water

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 1°C
- Humidity (%): 60 +/- 5%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: Right eye treated, left eye served as a control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g of ground material

Duration of treatment / exposure:

72 h after application, the treated eyes were analysed for cornea damage using a Na-fluorescein solution, then rinsed with warm physiological solution.

Observation period (in vivo):

21 d

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): after 72 h


SCORING SYSTEM: Draize (Appraisal of the safety of chemicals in foods, drugs and cosmetics, FDA, Austin 1, Texas 1959)


TOOL USED TO ASSESS SCORE: fluorescein and a slit lamp

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: up to 21 d

Score:

26.8

Max. score:

110

Reversibility:

other: Irreversible effects (cornea, iris) in 1/3 animals

Results 2

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

ca. 2

Max. score:

4

Reversibility:

fully reversible

Remarks:

in 2/3 animals

Remarks on result:

positive indication of irritation

Results 3

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

ca. 0.55

Max. score:

2

Reversibility:

fully reversible

Remarks:

in 2/3 animals

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. 2.67

Max. score:

3

Reversibility:

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. 0.89

Max. score:

4

Reversibility:

fully reversible within: 21 days

Remarks on result:

positive indication of irritation

Any other information on results incl. tables

Table 1: Scores for corneal effects (opacity) according to Draize, 1959

Animal N°	1 h	24 h	48 h	72 h	6, 8, 10, 13, 17 and 21 d
39653	0	20	20	10	0
39657	0	30	20	10	0
39689	0	30	30	20	10
Absolute average	0	26.67	23.33	13.33	3.33

Table 2: Scores for iris effects according to Draize, 1959

Animal N°	1 h	24 h	48 h	72 h	8, 10, 13, 17 and 21 d
39653	0	5x	5*	0	0
39657	0	5x	0	0	0
39689	0	5x	5*	0	5c
Absolute average	0	5.00	3.33	0	1.67

x: clear redness of the iris; * partial redness of the iris; c: circumcorneal injection

Table 3a: Scores for conjunctival effects (redness, swelling exsudation) according to Draize, 1959

Animal N°	1 h	24 h	48 h	72 h	6 d
39653	10	12	8	4	2
39657	10	12	8	2	0
39689	10	12	10	8	8
Absolute average	10.00	12.00	8.67	4.67	3.33

Table 3b: Scores for conjunctival effects (redness, swelling, exsudation) according to Draize, 1959 (cont'd)

Animal N°	8 d	10 + 13 d	17 d	21 d
39653	0	0	0	0
39657	0	0	0	0
39689	6	2	2	0
Absolute average	2.00	0.67	0.67	0

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 considered to be highly irritating to rabbit eyes.

Executive summary:

A study was conducted to assess the eye irritation potential of the test substance, C8-18 and C18-unsatd. MEA (100% active), in rabbits according to OECD Guideline 405. Ground neat test substance (0.1 g) was placed in the lid of the right eye of each Small White Russian rabbit. Seventy-two h after application, the treated eyes were analysed for corneal damage using a Na-fluorescein solution, then rinsed with warm physiological solution. Effects were evaluated at 1, 24, 48 and 72 h, as well as at 6, 8, 10, 13, 17 and 21 d after application, according to Draize (1959). Damage to the cornea and iris of one animal was still present after 21 d. This was considered irreversible. The mean overall score was 26.8 (maximum possible: 110). Under the study conditions, the test substance was considered to be highly irritating to rabbit eyes (Mürmann, 1988).