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Toxicological information

Skin sensitisation

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Administrative data

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

Data source

Reference
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)
Version / remarks:
12 May 1981
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
The study was performed before the LLNA became the standard method

Test material

Constituent 1
Chemical structure
Reference substance name:
1,2-dichloro-4-nitrobenzene
EC Number:
202-764-2
EC Name:
1,2-dichloro-4-nitrobenzene
Cas Number:
99-54-7
Molecular formula:
C6H3Cl2NO2
IUPAC Name:
1,2-dichloro-4-nitrobenzene
Test material form:
solid
Details on test material:
purity 99.8 %

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: BOR:DHPW
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: 4-8 weeks
- Weight at study initiation: 342 g (mean weight, 290 - 403 g)
- Housing: 5/cage
- Diet ad libitum
- Water ad libitum
- Acclimation period: 7 days


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

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
other: PEG 400
Concentration / amount:
5 %
Day(s)/duration:
Day 1
Route:
epicutaneous, occlusive
Vehicle:
other: PEG 400
Concentration / amount:
50 %
Day(s)/duration:
Day 8: for 48 hours
Adequacy of induction:
non-irritant substance, but skin pre-treated with 10% SDS
Challengeopen allclose all
No.:
#1
Route:
epicutaneous, semiocclusive
Vehicle:
other: PEG 400
Concentration / amount:
50 %
Day(s)/duration:
Week 3 for 24 h
No.:
#2
Route:
epicutaneous, semiocclusive
Vehicle:
other: PEG 400
Concentration / amount:
25 % and 12 %
Day(s)/duration:
Week 4 for 24 h
No. of animals per dose:
20 animals in the test group and 10 in each of the two control groups
Details on study design:
according to OECD TG 406
Challenge controls:
yes
Positive control substance(s):
no

Results and discussion

Positive control results:
none

In vivo (non-LLNA)

Resultsopen allclose all
Group:
positive control
Remarks on result:
not measured/tested
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
first provocation: 50 %
No. with + reactions:
12
Total no. in group:
20
Clinical observations:
reduced body weight gain
Reading:
2nd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
first provocation 50 %
No. with + reactions:
7
Total no. in group:
20
Clinical observations:
reduced body weight gain
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
Dose level:
first provocation 50 %
No. with + reactions:
7
Total no. in group:
10
Reading:
2nd reading
Hours after challenge:
72
Group:
negative control
Dose level:
first provocation : 50 %
No. with + reactions:
3
Total no. in group:
10
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
second provocation: 25 %
No. with + reactions:
3
Total no. in group:
20
Clinical observations:
reduced weight gain
Reading:
2nd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
second provocation: 25 %
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
reduced weight gain
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
Dose level:
second provocation: 25 %
No. with + reactions:
1
Total no. in group:
10
Reading:
2nd reading
Hours after challenge:
72
Group:
negative control
Dose level:
second provocation: 25 %
No. with + reactions:
0
Total no. in group:
10
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
second provocation: 12 %
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
reduced weight gain
Reading:
2nd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
second provocation : 12 %
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
reduced weight gain
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
Dose level:
second provocation: 12 %
No. with + reactions:
0
Total no. in group:
10
Reading:
2nd reading
Hours after challenge:
72
Group:
negative control
Dose level:
second provocation: 12 %
No. with + reactions:
0
Total no. in group:
10
Reading:
other: overall
Hours after challenge:
72
Group:
negative control
Dose level:
0 (no induction, no challenge)
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no findings

Any other information on results incl. tables

no mortality, reduced body weight gain in treated groups compared to the control group.


The skin reactions in the test animals as well as in the control animals consist of slight erythema of similar intensity.


Therefore 1,2 -dichchloronitrobenzene was evaluated to be a non-sensitizing substance.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the conditions of this Guinea Pig Maximization test 1,2 -dichloro-4 -nitrobenzene was evaluated as non-sensitizer (Bayer AG 1991).
Executive summary:

A Guinea Pig Maximization Test according to OECD Guideline 406 under GLP compliance was performed with the test item. Skin reactions after challenge were found in the test animals as well as in the control animals. They consisted of slight erythema of similar intensity. Therefore 1,2 -dichchloro-4-nitrobenzene was evaluated to be a non-sensitizing substance.  Under the conditions of this Guinea Pig Maximization test 1,2-dichloro-4-nitrobenzene was evaluated as non-sensitizer (Bayer AG 1991).