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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: limited but acceptable documented study report which meets basic scientific principles

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1973
Report date:
1973

Materials and methods

Principles of method if other than guideline:
other: eye irritation study in vivo
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
N-(1,4-dimethylpentyl)-N'-phenylbenzene-1,4-diamine
EC Number:
221-374-3
EC Name:
N-(1,4-dimethylpentyl)-N'-phenylbenzene-1,4-diamine
Cas Number:
3081-01-4
Molecular formula:
C19H26N2
IUPAC Name:
N1-(5-methylhexan-2-yl)-N4-phenylbenzene-1,4-diamine
Details on test material:
Santoflex 14

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Duration of treatment / exposure:
24 h
Observation period (in vivo):
7 d
Number of animals or in vitro replicates:
6

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
3.5
Max. score:
110
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: slightly erythema, discharge
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24 h
Score:
6.6
Max. score:
110
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: slight erythema, moderate to copious discharge
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 48 h
Score:
3.6
Max. score:
110
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: slight erythema, slight discharge
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Reversibility:
not specified
Remarks:
no details on chemosis reported
Remarks on result:
other: no details on chemosis reported
Remarks:
.
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Reversibility:
not specified
Remarks:
no details on cornea opacity reported
Remarks on result:
other: no details on cornea opacity reported
Remarks:
.
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Reversibility:
not specified
Remarks:
no details on iris score reported.
Remarks on result:
other: no details on iris score reported.
Remarks:
.
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Reversibility:
not specified
Remarks:
no details on conjunctivae score reported.
Remarks on result:
other: no details on conjunctivae score reported.
Remarks:
.

Any other information on results incl. tables

Immediate after application: slight discomfort

1 hour after application: slight erythema, very slight edema, copious discharge

Applicant's summary and conclusion

Interpretation of results:
not irritating