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Diss Factsheets

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:
1988
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 (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
N,N'-(2,5-dichloro-1,4-phenylene)bis[4-[(2,5-dichlorophenyl)azo]-3-hydroxynaphthalene-2-carboxamide]
EC Number:
255-005-2
EC Name:
N,N'-(2,5-dichloro-1,4-phenylene)bis[4-[(2,5-dichlorophenyl)azo]-3-hydroxynaphthalene-2-carboxamide]
Cas Number:
40618-31-3
Molecular formula:
C40H22Cl6N6O4
IUPAC Name:
N,N'-(2,5-dichloro-1,4-phenylene)bis{4-[(2,5-dichlorophenyl)diazenyl]-3-hydroxy-2-naphthamide}
Test material form:
solid
Details on test material:
- Substance type: red solid
- Physical state: solid
- Analytical purity: approx 100%
- Purity test date: no data
- Lot/batch No.: 4235
- Expiration date of the lot/batch: March 10, 1990
- Stability under test conditions: stable
- Storage condition of test material: at room temperature in the dark
Specific details on test material used for the study:
- Substance type: red solid
- Physical state: solid
- Analytical purity: approx 100%
- Purity test date: no data
- Lot/batch No.: 4235
- Expiration date of the lot/batch: March 10, 1990
- Stability under test conditions: stable
- Storage condition of test material: at room temperature in the dark

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, Kleintierfarm Madoerin AG, CH-4414 Fuellinsdorf
- Age at study initiation: 14 - 15 weeks
- Weight at study initiation: males 2.5 kg, female 2.8 kg
- Housing: single
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: four days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20+-3 degrees centigrade
- Humidity (%): 40-70 %,
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 1989-04-04 To: 1989-04-07

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.1 g
Duration of treatment / exposure:
single treatment
Observation period (in vivo):
72h
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: not performed


SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: A slit-lamp 30 SL/M (C. Zeiss AG, Zuerich / Switzerland) and a Varta Cliptrix diagnostic-lamp (A. Riegger, Basel /
SWitzerland) were both used

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24 - 72 hours
Score:
0
Max. score:
4
Reversibility:
other: not applicable, as no effects
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24 - 72 hours
Score:
0
Max. score:
2
Reversibility:
other: not applicable, as no effects
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24 - 72 hours
Score:
0
Max. score:
3
Reversibility:
other: not applicable, as no effects
Other effects:
Red staining of the eyelashes of the treated eyes by pigment or coloring of the test article was observed in all three animals from 1 hour to 72 hours after the test article application.
No corrosion was observed at any of the measuring intervals.

Any other information on results incl. tables

No acute toxic symptoms were observed in the animals during the test period, and no mortality occurred.

The body weight gain of all rabbits was similar.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met