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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:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
guinea pig maximisation test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
IUCLID4 Test substance: other TS: 1,2-dichloro-4-nitrobenzene, 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)
- 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 and epicutaneous
Vehicle:
other: PEG 400
Concentration / amount:
1. intradermal Induction. 5 %
2. dermal induction: 50 %
3. first provocation: 50 %
4. second provocation: 25 % and 12 %
Challengeopen allclose all
Route:
epicutaneous, semiocclusive
Vehicle:
other: PEG 400
Concentration / amount:
1. intradermal Induction. 5 %
2. dermal induction: 50 %
3. first provocation: 50 %
4. second provocation: 25 % and 12 %
No. of animals per dose:
20 animals in the test group and 10 in controls
Details on study design:
according to OECD TG 406
Challenge controls:
yes
Positive control substance(s):
no

Study design: in vivo (LLNA)

Positive control substance(s):
not specified
Statistics:
no data

Results and discussion

Positive control results:
none

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
48
Group:
test group
Dose level:
first provocation: 50 %
No. with + reactions:
12
Total no. in group:
20
Clinical observations:
reduced body weight gain
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: first provocation: 50 %. No with. + reactions: 12.0. Total no. in groups: 20.0. Clinical observations: reduced body weight gain.
Reading:
2nd reading
Hours after challenge:
72
Group:
test group
Dose level:
first provocation
No. with + reactions:
7
Total no. in group:
20
Clinical observations:
rduced body weight gain
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: first provocation. No with. + reactions: 7.0. Total no. in groups: 20.0. Clinical observations: rduced body weight gain.
Reading:
1st reading
Hours after challenge:
48
Group:
other: control
Dose level:
first porvocation 50 %
No. with + reactions:
7
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group:
Reading:
2nd reading
Hours after challenge:
72
Group:
other: control
Dose level:
first provocation : 50 %
No. with + reactions:
3
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 72.0. Group:
Reading:
1st reading
Hours after challenge:
48
Group:
test group
Dose level:
second provocation: 25 %
No. with + reactions:
3
Total no. in group:
20
Clinical observations:
reduced weight gain
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: second provocation: 25 %. No with. + reactions: 3.0. Total no. in groups: 20.0. Clinical observations: reduced weight gain.
Reading:
2nd reading
Hours after challenge:
72
Group:
test group
Dose level:
second provocation: 25 %
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
reduced weight gain
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: second provocation: 25 %. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: reduced weight gain.
Reading:
1st reading
Hours after challenge:
48
Group:
other: control
Dose level:
second provocation: 25 %
No. with + reactions:
1
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group:
Reading:
2nd reading
Hours after challenge:
72
Group:
other: control
Dose level:
second provocation: 25 %
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 72.0. Group:
Reading:
1st reading
Hours after challenge:
48
Group:
test group
Dose level:
second provocation: 12 %
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
reduced weight gain
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: second provocation: 12 %. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: reduced weight gain.
Reading:
2nd reading
Hours after challenge:
72
Group:
test group
Dose level:
second provocation : 12 %
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
reduced weight gain
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: second provocation : 12 %. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: reduced weight gain.
Reading:
1st reading
Hours after challenge:
48
Group:
other: control
Dose level:
second challenge: 12 %
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group:
Reading:
2nd reading
Hours after challenge:
72
Group:
other: control
Dose level:
second provocation
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 72.0. Group:
Reading:
other: overall
Hours after challenge:
72
Group:
negative control
Dose level:
no testsubstance
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no findings
Remarks on result:
other: Reading:

Any other information on results incl. tables

RS-Freetext:
no mortality, reduced body weight gain compared to the control group

The positive 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:
not sensitising
Remarks:
Migrated information
Executive summary:

Under the conditions of this Guinea Pig Maximization test 1,2 -dichloro-4 -nitrobenzene was evaluated as non-sensitizer (Bayer AG 1991)