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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

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Diss Factsheets

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Equivalent to OECD 405. No GLP study.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report date:
1987

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
(no data recorded on body weights)
GLP compliance:
no

Test material

Constituent 1
Reference substance name:
Benzenamine, reaction products with aniline hydrochloride and nitrobenzene, hydrochlorides
EC Number:
309-913-1
EC Name:
Benzenamine, reaction products with aniline hydrochloride and nitrobenzene, hydrochlorides
Cas Number:
101357-16-8
Molecular formula:
Not applicable. Multiconstituent substance.
IUPAC Name:
(2Z,7Z)-5-phenyl-2,7-bis(phenylimino)-2,7-dihydro-5λ⁵-phenazin-5-ylium (7Z)-N2,N3,5-triphenyl-7-(phenylimino)-5,7-dihydrophenazine-2,3-diamine N2,N3,5,7-tetraphenyl-5,7,12,14-tetrahydro-5,7,12,14-tetraazapentacene-2,3-diamine chloride

Test animals / tissue source

Species:
rabbit
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Weight at study initiation: approx. 3 kg
- Housing: Individual cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 1 week

Test system

Vehicle:
other: ethyl alcohol (10%)
Controls:
other: the vehicle was applied to the control eyes.
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): A solution of 0.4 g/ml of the test substance in ethyl alcohol (10%) was prepared. 0.1 ml of this solution were applied to the animals´treated eyes (equivalent to 40 mg of the test substance).

Observation period (in vivo):
1, 24, 48 hours, 5 and 7 days
Number of animals or in vitro replicates:
Three animals
Details on study design:
SCORING SYSTEM:

Cornea
Opacity:
No ulceration or opacity 0
Scattered or diffuse areas of opacity, details of iris clearly visible 1
Easily discernible translucent area, details of iris slightly obscured 2
Nacreous area, no details of iris visible, size of pupil barely discernible 3
Opaque cornea, iris not discernible 4

Iris
Normal 0
Markedly deepened rugae, congestion, swelling, moderate circumcorneal hyperaemia or injection, iris reactive to light (a sluggish reaction is considered to be an effect) 1
Hemorrhage, gross destruction, or no reaction to light 2

Conjunctivae
Redness:
Normal 0
Some blood vessels hyperaemic (injected) 1
Diffuse, crimson colour, individual vessels not easily discernible 2
Diffuse beefy red 3

Chemosis
Normal 0
Some swelling above normal 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:
mean
Time point:
other: 1 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
48 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
72 h
Score:
0
Remarks on result:
other: Instead 72h the 5d reading was done.
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
7 d
Score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 1 h
Score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
24 h
Score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
48 h
Score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
72 h
Score:
0
Remarks on result:
other: Instead 72h the 5d reading was done.
Irritation parameter:
iris score
Basis:
mean
Time point:
7 d
Score:
0
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 1 h
Score:
0
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24 h
Score:
0
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
48 h
Score:
0
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
72 h
Score:
0
Remarks on result:
other: Instead 72h the 5d reading was done.
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
7 d
Score:
0
Irritation parameter:
chemosis score
Time point:
24/48/72 h
Remarks on result:
not measured/tested

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the available results, the test substance is not classified as eye irritating.
Executive summary:

The test item was applied to one eye of each of the three animals. Observations of the treated eyes were performed at 1, 24, 48 hours, 5 and 7 days after the start of the exposure. Based on the available results, the test substance is not classified as eye irritating.