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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:
7 November 1989
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report date:
1989

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
Reaction mass of hydrogen [1-[(2-hydroxy-4-nitrophenyl)azo]-2-naphtholato(2-)][1-[(2-hydroxy-5-nitrophenyl)azo]-2-naphtholato(2-)]chromate(1-) , compound with 3-[(2-ethylhexyl)oxy]propylamine (1:1) and hydrogen bis[1-[(2-hydroxy-4-nitrophenyl)azo]-2-naphtholato(2-)]chromate(1-) , compound with 3-[(2-ethylhexyl)oxy]propylamine (1:1) and hydrogen bis[1-[(2-hydroxy-5-nitrophenyl)azo]-2-naphtholato(2-)]chromate(1-) , compound with 3-[(2-ethylhexyl)oxy]propylamine (1:1)
IUPAC Name:
Reaction mass of hydrogen [1-[(2-hydroxy-4-nitrophenyl)azo]-2-naphtholato(2-)][1-[(2-hydroxy-5-nitrophenyl)azo]-2-naphtholato(2-)]chromate(1-) , compound with 3-[(2-ethylhexyl)oxy]propylamine (1:1) and hydrogen bis[1-[(2-hydroxy-4-nitrophenyl)azo]-2-naphtholato(2-)]chromate(1-) , compound with 3-[(2-ethylhexyl)oxy]propylamine (1:1) and hydrogen bis[1-[(2-hydroxy-5-nitrophenyl)azo]-2-naphtholato(2-)]chromate(1-) , compound with 3-[(2-ethylhexyl)oxy]propylamine (1:1)
Test material form:
solid: particulate/powder
Details on test material:
- Description: Black powder
- Storage Conditions: Room temperature

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Age at study initiation: Approximately 11 to 15 weeks of age.
- Weight at study initiation: 2.6 to 3.4 kg
- Housing: The rabbits were individually housed in metal cages with perforated floors.
- Diet: Ad libitum
- Water: Ad libitum
- Acclimation: The rabbits selected for the study were all acclimated to the laboratory environment.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): Approximately 19 °C
- Humidity (%): 30 - 70 % relative humidity.
- Air changes (per hr): Approximately 19 air changes per hour.
- Photoperiod (hrs dark / hrs light): 12 hours dark/ 12 hours light.


.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The contralateral eye remained untreated and served as a control.
Amount / concentration applied:
TEST MATERIAL
- Amount applied: Approximately 70 mg of test material, the weight occupying a volume of 0.1 mL; the eyelids were then held gently together for one second before releasing.
Duration of treatment / exposure:
The test material was not removed and therefore the duration of treatment was 7 days.
Observation period (in vivo):
Examination of the eyes was made after 1 hour and 1, 2, 3, 4 and 7 days after instillation. All animals were observed daily for signs of ill health or toxic signs.
Number of animals or in vitro replicates:
Three animals; two males and one female.
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: The test material was not removed.

TOOL USED TO ASSESS SCORE: Observation of the eyes was aided by the use of a handheld torch.

SCORING SYSTEM: Grading and scoring of the ocular lesions were performed using the prescribed numerical scoring system as follows:

CORNEA
Opacity: Degree of density (area most dense taken for reading)
No ulceration or opacity: 0
Scattered or diffuse areas of opacity (other than slight dulling of normal lustre), details of iris clearly visible: 1
Easily discernible translucent areas, details of iris slightly obscured: 2
Nacrous areas, no details of iris visible, size of pupil barely discernible: 3
Opaque cornea, iris not discernible through the opacity: 4

AREA OF CORNEA INVOLVED
One quarter (or less) but not zero: 1
Greater than one quarter, but less less half: 2
Greater than half, but less than three quarters: 3
Greater than three quarters, up to whole area: 4

IRIS
Normal: 0
Markedly deepened rugae, congestion, swelling, moderate circumcorneal hyperaemia or injection, any of these or combination of any thereof, iris still reacting to light (sluggish reaction is positive):1
No reaction to light, haemorrhage, gross destruction (any or all of these): 2

CONJUCTIVAE
Redness (refers to palpebral and bulbar conjunctivae cornea and iris)
Blood vessels normal: 0
Some blood vessels definitely hyperaemic (injected): 1
Diffuse, crimson colour, individual vessels not easily discernible: 2
Diffuse, beefy red: 3

CHEMOSIS (lids and/or nictitating membranes)
No swelling: 0
Any swelling above normal (includes nictitating membranes): 1
Obvious swelling with partial eversion of lids: 2
Swelling with lids about half-closed: 3
Swelling with lids more than half-closed: 4

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
other: All three animals tested
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: Not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
other: All three animals tested
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: Not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
other: All three animals tested
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
other: Not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
other: All three animals tested
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: Not applicable
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
No corneal damage or iridial inflammation was seen throughout the observation period.
Mild conjunctival inflammation was present one hour after instillation only in all three animals.

Applicant's summary and conclusion

Interpretation of results:
other: Not classified in accordance with EU criteria.
Conclusions:
Under the conditions of the study, the test material does not cause eye irritation.
Executive summary:

The potential of the test material to cause eye irritation was determined in a GLP study which was conducted in accordance with the standardised guidelines OECD 405.

The eye irritation potential of the test material was investigated in New Zealand White rabbits. The eyes of each animal were examined prior to instillation of the test material to ensure that there was no pre-existing corneal damage or conjunctival inflammation. Approximately 70 mg of test material, the weight occupying a volume of 0.1 mL, was placed into the lower everted lid of one eye of each animal. The eyelids were then gently held together for one second before releasing. The contralateral eye remained untreated and served as a control. Examination of the eyes was made after 1 hour and 1, 2, 3, 4 and 7 days after instillation. Observation of the eyes was aided by the use of a handheld torch. The eyes were then graded and scored to determine eye irritation.

Under the conditions of the study, the test material does not cause eye irritation.