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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:
February 16, 1988 to March 09, 1988
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions

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
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 (CAS 68140-00-1)
- 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:
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Dr. Karl Thomae GnbH, 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

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:
animal: All
Time point:
24/48/72 h
Score:
>= 10 - <= 30
Max. score:
30
Reversibility:
not fully reversible within: 21 d
Remarks:
Not reversible in 1/3 animals
Irritation parameter:
iris score
Basis:
animal: All
Time point:
24/48/72 h
Score:
>= 0 - <= 5
Max. score:
5
Reversibility:
not fully reversible within: 21 d
Remarks:
Not reversible in 1/3 animals
Irritation parameter:
conjunctivae score
Basis:
animal: All
Time point:
24/48/72 h
Score:
>= 2 - <= 12
Max. score:
12
Reversibility:
fully reversible within: 21 d
Irritation parameter:
chemosis score
Basis:
animal: All
Time point:
24/48/72 h
Remarks on result:
other: Not specified

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 conditions of the study, the test substance 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 the test substance to rabbit eyes according to OECD Guideline 405. An amount equivalent to 0.1 g of ground substance was placed in the lid of the right eye of each rabbit. The treated eyes were analysed 72 h after application for cornea 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 still present after 21 d was considered irreversible. The mean overall score was 26.8 (maximum possible: 110). Under the conditions of the study, the test substance was considered to be moderately irritating to rabbit eye. In one animal, irreversible effects (cornea, iris) occurred (Mürmann, 1988).