Registration Dossier

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 and GLP

Data source

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

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Qualifier:
according to
Guideline:
other: EG-Richtlinie 84/449: Einstufung, Verpackung und Kennzeichnung gefährlicher Stoffe, "Akute Toxizität-Sensibilisierung der Haut" [8].
GLP compliance:
yes
Type of study:
guinea pig maximisation test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
TS-Freetext:
Purity: 99.5 %

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Bor:DHPW
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source:
- Age at study initiation: 4-7 weeks
- Weight at study initiation: 334 g (295-386 g)
- Housing:
- Diet ad libitum
- Water ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21
- Humidity (%): 40-70
- Air changes (per hr): 12-15
- Photoperiod (hrs dark / hrs light): 12/12

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
other: 2% Cremophor EL in saline
Concentration / amount:
Induction:
1st application: 2.5 % intracutaneous
2nd application: I2 % occlusive epicutaneous
Challenge
3 %,, occlusive, epicutaneous
6 % , occlusive, epicutaneous
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: 2% Cremophor EL in saline
Concentration / amount:
Induction:
1st application: 2.5 % intracutaneous
2nd application: I2 % occlusive epicutaneous
Challenge
3 %,, occlusive, epicutaneous
6 % , occlusive, epicutaneous
No. of animals per dose:
10 (control groups); 20 (test substance groups)
Details on study design:
according to OECD TG 406
Challenge controls:
yes: vehicle
Positive control substance(s):
not specified

Study design: in vivo (LLNA)

Statistics:
no data

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
Dose level:
6%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 6%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
48
Group:
test group
Dose level:
6%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 6%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
72
Group:
negative control
Dose level:
6%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: negative control. Dose level: 6%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
72
Group:
test group
Dose level:
6%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 6%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
Dose level:
3%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 3%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
48
Group:
test group
Dose level:
3%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 3%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
72
Group:
negative control
Dose level:
3%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: negative control. Dose level: 3%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
72
Group:
test group
Dose level:
3%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 3%. No with. + reactions: 0.0. Total no. in groups: 20.0.

Applicant's summary and conclusion

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

In a Guinea PigMaximization Test according to OECD TG 400 (Magnusson and Klingman) male guinea pigs were tested with following concentrations of the test substance:

1st application: Induction 2.5 % intracutaneous

2nd application: Induction 12 % occlusive epicutaneous

3rd application: Challenge 6 % and 3% occlusive epicutaneous

The test substance was formulated as an emulsion with Cremophor EL in sterile physiological saline solution (2% V/V).

No skin reddening was observed after the provocation with 6% and 3% of test substance neither in the test animals nor in the control animals. The test substance therefore shows no skin sensitating potential (Bayer AG 1993).