Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report date:
1991

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of study:
guinea pig maximisation test

Test material

Constituent 1
Chemical structure
Reference substance name:
1,4-dichloro-2-(1,1,2,3,3,3-hexafluoropropoxy)-5-nitrobenzene
EC Number:
620-459-6
Cas Number:
130841-23-5
Molecular formula:
C9H3Cl2F6NO3
IUPAC Name:
1,4-dichloro-2-(1,1,2,3,3,3-hexafluoropropoxy)-5-nitrobenzene

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Pirbright White Strain
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Breeder: Ciba-Geigy Limited, Tierfarm
- Age at study initiation: approx. 10 weeks old
- Weight at study initiation: 348 to 437 g
- Housing: individually in Macrolon cages (Type 3)
- Diet (e.g. ad libitum): standard pellets (NAFAG No. 845) and fresh water
- Acclimation period:


ENVIRONMENTAL CONDITIONS
- Temperature (°C): ca. 22
- Humidity (%): 30 to 70
- Photoperiod (hrs dark / hrs light): 12 hours

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
other: vaseline
Concentration / amount:
Interdermal injections: 5%; Ol. arachidis was chosen as vehicle for intradermal injections because the test article could not be dissolved or evenly dispersed in any other standard vehicle which is routinely used.
Epidermal application: 1, 5, 10, 30 % in vaseline
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: vaseline
Concentration / amount:
Interdermal injections: 5%; Ol. arachidis was chosen as vehicle for intradermal injections because the test article could not be dissolved or evenly dispersed in any other standard vehicle which is routinely used.
Epidermal application: 1, 5, 10, 30 % in vaseline
Details on study design:
RANGE FINDING TESTS:


MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Exposure period:
- Test groups:
- Control group:
- Site:
- Frequency of applications:
- Duration:
- Concentrations:


B. CHALLENGE EXPOSURE
- No. of exposures: 2
- Day(s) of challenge:
- Exposure period:
- Test groups:
- Control group:
- Site:
- Concentrations:
- Evaluation (hr after challenge):


OTHER:

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
0
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
5%
No. with + reactions:
13
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 5%. No with. + reactions: 13.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
5%
No. with + reactions:
5
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 5%. No with. + reactions: 5.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
24
Group:
test chemical
Dose level:
5%
No. with + reactions:
17
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 24.0. Group: test group. Dose level: 5%. No with. + reactions: 17.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
5%
No. with + reactions:
10
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 5%. No with. + reactions: 10.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
24
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 20.0.

Applicant's summary and conclusion

Interpretation of results:
sensitising
Remarks:
Migrated information
Conclusions:
Under the experimental conditions of this test, 65 and 25% of the animals showed a positiv reaction 24 and 48 hours after the first challenge application. A second challenge resulted in 85 and 50% positiv animals at the readings 24 and 48 hours, respectively.
The higher incidence of positive animals upon the second challenge application indicates that the reactions observed were allergic. It has to be concluded, therefore, that CGA 230672 techn. has a moderate skin-sensitising (contact allergenic) potential in albino guinea pigs.