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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
other information
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report date:
1992

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
guinea pig maximisation test

Test material

Constituent 1
Chemical structure
Reference substance name:
2-chloro-4-nitrotoluene
EC Number:
204-501-7
EC Name:
2-chloro-4-nitrotoluene
Cas Number:
121-86-8
Molecular formula:
C7H6ClNO2
IUPAC Name:
2-chloro-1-methyl-4-nitrobenzene
Details on test material:
- Name of test material (as cited in study report): 2-Chlor-4-nitrotoluol rein krist.
- Purity: 99.4 %

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Bor: DHPW
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Versuchstierzucht Winkelmann (Borchen, Germany)
- Age at study initiation: 5-7 weeks
- Weight at study initiation: 295-365 g
- Housing: 5 animals per cage (Makrolon cages type IV) on low dust wood granulate bedding
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2
- Humidity (%): ca. 50
- Air changes (per hr): approx. 10
- Photoperiod (hrs dark / hrs light): 12 / 12

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
other: polyethylene glycol 400
Concentration / amount:
1st induction (intradermal): 5 %
2nd induction (epicutaneous): 50 %
1st and 2nd challenge (epicutaneous): 50 % and 25 %
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: polyethylene glycol 400
Concentration / amount:
1st induction (intradermal): 5 %
2nd induction (epicutaneous): 50 %
1st and 2nd challenge (epicutaneous): 50 % and 25 %
No. of animals per dose:
20 (test groups), 10 (control groups)
Details on study design:
INTRADERMAL INDUCTION:
Three pairs of intradermal injections were made at the clipped skin site of each animal. A volume of 0.1 ml was injected. Animals of the test group were treated at the following injection sites: 
cranial - emulsified Freund's complete adjuvant 1:1 with physiologic saline
medial - 5 % test item in polyethylene glycol 400
caudal - 5 % test item in polyethylene glycol 400 and emulsified Freund's complete aduvant 1:1
Animals of the control group were treated in the same manner excepted that the test item was replaced by the vehicle alone.

TOPICAL INDUCTION:
Treatment group: 0.5 ml of 50 % test item in polyethylene glycol 400; control group: 0.5 ml polyethylene glycol 400

CHALLENGE:
3 weeks after the first induction phase all animals were prepared for challenge by clipping the flanks and backs free of hair. Patches of gauze coated with 0.5 ml aliquots of the test item at 25 or 50 % concentrations were placed alternating cranial or caudal of each animal and fixed with an elastic adhesive bandage. After a contact period of 24 hours patches were removed. The treated sites were examined approximately 48 and 72 hours after patch  removal.
Positive control substance(s):
no

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
50 % test substance formulation
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
none
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50 % test substance formulation. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
Reading:
2nd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
50 % test substance formulation
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
none
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 50 % test substance formulation. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
Dose level:
50 % test substance formulation
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 50 % test substance formulation. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
Reading:
2nd reading
Hours after challenge:
72
Group:
negative control
Dose level:
50 % test substance formulation
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: negative control. Dose level: 50 % test substance formulation. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
25 % test substance formulation
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
none
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25 % test substance formulation. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
Reading:
2nd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
25 % test substance formulation
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
none
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 25 % test substance formulation. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
Dose level:
25 % test substance formulation
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 25 % test substance formulation. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
Reading:
2nd reading
Hours after challenge:
72
Group:
negative control
Dose level:
25 % test substance formulation
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: negative control. Dose level: 25 % test substance formulation. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.

Any other information on results incl. tables

Treatment with 2-chloro-4-nitrotoluene was tolerated by all animals without symptoms. No deaths occurred. Body weight development was not affected.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Executive summary:

In a guinea pig maximization test (GPMT) according to OECD TG 406 2-Chlor-4-nitrotoluol rein krist. revealed no skin sensitizing potential at challenge concentrations of 50 and 25 %.