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Toxicological information

Eye irritation

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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
Study period:
February 16, 1988 to March 09, 1988
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study was conducted according to OECD Guideline 405
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report Date:
1988

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Principles of method if other than guideline:
Not applicable
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Marlamid 1218
- Physical state: Solid
- Analytical purity: 100 %
- Lot/batch No.: 3
- Other: pH ca. 9 (at 20 g/L), odour: amine-like, Melting point: ca. 69-73 °C

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 hours


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
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
Remarks on result:
other: -
Irritant / corrosive response data:
None
Other effects:
None

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 exudation) 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, exudation) 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:
highly irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the test conditions, amides, C8-18 (even numbered) and C18-unsatd., N-(hydroxyethyl) was considered to be moderately irritating to rabbit eye. In one animal, irreversible effects (cornea, iris) occurred.
Executive summary:

A study was conducted to assess the eye irritation potential of structurally similar amides, C18-18 (even numbered) and C18-unsatd., N-(hydroxyethyl) to rabbit eyes according to OECD guideline 405. 0.1 g of ground neat test substance was placed in the lid of the right eye of each rabbit. 72 hours after application, the treated eyes were analysed for cornea damage using a Na-fluorescein solution, then rinsed with warm physiological solution. Effects were evaluated at 1, 24, 48 and 72 hours, as well as at 6, 8, 10, 13, 17 and 21 days after application according to Draize method. Damage still present after 21 days was considered to be irreversible. The mean overall score was 26.8 (maximum possible: 110). Under the conditions of the study, the test substance was considered to be highly irritating to rabbit eye based the irreversible effects noted in cornea and iris of one animal