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Toxicological information

Eye irritation

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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

Constituent 1
Reference substance name:
Amides, C8-18 and C18-unsatd., N-(hydroxyethyl)
EC Number:
931-330-1
Molecular formula:
The alkyl chain length of the amide ranges between 8 and 18 carbon atoms
IUPAC Name:
Amides, C8-18 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

Resultsopen allclose all
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
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
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
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
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 
 39657  0 30 20  10  0
 39689  0  30  30  20  10
 Absolute average  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 5x 0  0 0
 39689  5x  5*  0 5c
 Absolute average 0  5.00 3.33   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 
 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
 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, 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).