Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

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
Study period:
1976
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well-documented study report which meets basic scientific principles.
Cross-reference
Reason / purpose for cross-reference:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1976
Report date:
1976

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: FDA guideline (Fed. Reg. Vol. 38, No. 187, p. 27019, 1973)
Deviations:
not specified
GLP compliance:
no
Remarks:
GLP was not compulsory at the time the study was conducted

Test material

Constituent 1
Chemical structure
Reference substance name:
3-hydroxy-4-[(2-methyl-4-nitrophenyl)azo]-N-(o-tolyl)naphthalene-2-carboxamide
EC Number:
229-102-5
EC Name:
3-hydroxy-4-[(2-methyl-4-nitrophenyl)azo]-N-(o-tolyl)naphthalene-2-carboxamide
Cas Number:
6410-32-8
Molecular formula:
C25H20N4O4
IUPAC Name:
3-hydroxy-4-[(2-methyl-4-nitrophenyl)diazenyl]-N-(2-methylphenyl)-2-naphthamide
Test material form:
solid: nanoform, no surface treatment
Details on test material:
Name of test material (as cited in study report): Permanentbordo FRR CM
Analytical purity: technically pure

Test animals / tissue source

Species:
rabbit
Strain:
Himalayan
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Housing: individually
- Weight at study initiation: 1.5-2.0 kg
- Diet: mixed feed ERKA 8300 (Robert Koch, Hamm), ad libitum
- Water: tap water, ad libitum

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
100 mg
Duration of treatment / exposure:
24 h
Observation period (in vivo):
72 h
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with physiological saline
- Time after start of exposure: 24 h

SCORING SYSTEM: basically in accordance with OECD TG 405.
Scores were read 1, 7, 24, 48 and 72 h after test substance application.

TOOL USED TO ASSESS SCORE: hand-slit lamp / fluorescein at 48 and 72 h reading

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not relevant since no effects
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not relevant since no effects
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not relevant since no effects
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not relevant since no effects
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not relevant since no effects
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not relevant since no effects
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: reversibility not relevant since no effects
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: reversibility not relevant since no effects
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: reversibility not relevant since no effects
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: reversibility not relevant since no effects
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: reversibility not relevant since no effects
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
other: reversibility not relevant since no effects
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
other: reversibility not relevant since no effects
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
other: reversibility not relevant since no effects
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
other: reversibility not relevant since no effects
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
other: reversibility not relevant since no effects
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
other: reversibility not relevant since no effects
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not relevant since no effects
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not relevant since no effects
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not relevant since no effects
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not relevant since no effects
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not relevant since no effects
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not relevant sice no effects
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
One animal showed discharge (score 1) after 1 h. This effect was fully reversible after 7 h. No other effects were observed for any end point at any time point.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test material was not irritating to eyes in all animals under test conditions which are basically in accordance with todays standard methods regarding dosing, exposure duration, scoring system and reading time points. Therefore, it is concluded that the submission substance is not irritating to eyes.
Executive summary:

Test material was subject to a test of eye irritancy according to FDA guidelines (Fed. Reg. Vol. 38, No. 187, p. 27019, 1973). 100 mg of substance were applied to one eye of six animals. The eyes were washed 24 h after application and eye responses were noted for 72 h.

No responses of the eyes were observed within 72 hours after application except for one animal which showed a slight discharge (score 1) after 1 h which was fully reversible within 7 h. Therefore, it is concluded that the submission substance is not irritating to eyes.