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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1991
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: report available, GLP study;

Data source

Referenceopen allclose all

Reference Type:
secondary source
Title:
Unnamed
Year:
1995
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report date:
1991

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
not specified
Type of study:
guinea pig maximisation test

Test material

Constituent 1
Reference substance name:
2-Methoxy-4-nitro-aniline
IUPAC Name:
2-Methoxy-4-nitro-aniline
Constituent 2
Chemical structure
Reference substance name:
4-nitro-o-anisidine
EC Number:
202-588-6
EC Name:
4-nitro-o-anisidine
Cas Number:
97-52-9
Molecular formula:
C7H8N2O3
IUPAC Name:
2-methoxy-4-nitroaniline
Constituent 3
Reference substance name:
PNOA
IUPAC Name:
PNOA

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female
Details on test animals and environmental conditions:
no data

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
other: intradermal: Alembicol D (triglyceride); epidermal: water
Concentration / amount:
intradermal: 7.5 % (w/w)
epidermal: induction: 75 %
epidermal: induction: 75 and 40 %
Challengeopen allclose all
Route:
other: epicutaneous, no further data
Vehicle:
other: intradermal: Alembicol D (triglyceride); epidermal: water
Concentration / amount:
intradermal: 7.5 % (w/w)
epidermal: induction: 75 %
epidermal: induction: 75 and 40 %
No. of animals per dose:
20
Details on study design:
RANGE FINDING TESTS: no data

MAIN STUDY
- No. of exposures: 2
- Test groups: 1
- Control group: 1
Positive control substance(s):
no
Remarks:
Formalin was tested as a positive control regulaly but not included in this study

Results and discussion

Positive control results:
no data

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
40 %
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no effects
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 40 %. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no effects.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
40 %
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no effects
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 40 %. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no effects.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
Classification: not sensitizing