Registration Dossier

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1993
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP-Guideline study without deviations

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993
Report Date:
1993

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
1987
Deviations:
yes
Remarks:
Evaluation 24, 48 and 72 hours after challenge
GLP compliance:
yes (incl. certificate)
Remarks:
Ministerium für Umwelt, Raumordnung und Landwirtschaft des Landes Nordrhein-Westfalen
Type of study:
Buehler test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): n-Butylchlorid
- Storage condition of test material: closed, desiccator, under local exhaust ventilation

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Fa. Harlan-Winkelmann, Borchen, Germany
- Age at study initiation: healthy young adults
- Weight at study initiation: 436 - 527 g
- Housing: conventional, max. 5 animals per cage (Makrolon Type IV)
- Diet: Ssniff G 4 ad libitum
- Water: tap water ad libitum
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 30 -70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 / 12


Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
maize oil
Concentration / amount:
Conc. 50 % (w/w) in maize oil (MEH 56) (induction and challenge)
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
maize oil
Concentration / amount:
Conc. 50 % (w/w) in maize oil (MEH 56) (induction and challenge)
No. of animals per dose:
Test group: 20
Controls: 10
Details on study design:
Application volume: 0,4 mL

RANGE FINDING TESTS: 2,5; 25; 50% (w/w) in maize oil (MEH 56) and 100% (w/w)


MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 hours
- Test groups: 20 animals
- Control group: 10 animals
- Site: left flank
- Induction on days: 0, 7, 14
- Concentration: 50% (w/w) in maize oil (MEH 56)


B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Challenge on day: 28
- Exposure period: 6 hours
- Test groups: 20 animals
- Control group: 10 animals
- Site: right flank
- Concentration: 50% (w/w) in maize oil (MEH 56)
- Evaluation (hr after challenge): 24, 48 and 72


Positive control substance(s):
yes
Remarks:
1-Chlor-2,4-dinitrobenzol (HS-92/CDNB-1; 25.04.1993 - 27.05.1993)

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
50% (w/w)
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50% (w/w). No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
50% (w/w)
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50% (w/w). No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
other: 3rd reading
Hours after challenge:
72
Group:
test group
Dose level:
50% (w/w)
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading:
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
50% (w/w)
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: 50% (w/w). No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
50% (w/w)
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 50% (w/w). No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
other: 3rd reading
Hours after challenge:
72
Group:
negative control
Dose level:
50% (w/w)
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading:

Applicant's summary and conclusion

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