Registration Dossier

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study according to Buehler protocol which satisfies the citeria of toxic control act (40 CFR) and the OECD Guideline, GLP, well documented

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report Date:
1990

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
Conducted to general conditions satisfying the OECD Guideline
GLP compliance:
yes
Type of study:
Buehler test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Chemical name: Mixture of N,N-Dimethydecan-1-amide and N,N-Dimethyloctan-1-amide
- Physical state: liquid
- Storage condition of test material: roomtemperature

In vivo test system

Test animals

Species:
guinea pig
Strain:
Hartley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: approved supplier
- Weight: 374-623g
- Housing: wire mesh suspension cages
- Diet (e.g. ad libitum): ad libitum, PURINA GUINEA PIG CHOW
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least four days


ENVIRONMENTAL CONDITIONS
- Photoperiod (hrs dark / hrs light): 12h each

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: 80/20 ethanol/dest water; acetone
Concentration / amount:
Pilot: 100% (without vehicle), 50%, 25%, 10%, 5%, 2.5%, 1%, 0.5% (partly in 80/20 ethanol/dest water)
Main study Induction: 5% (in 80/20 ethanol/dest water)
Challenge: 2.5% (in acetone)
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: 80/20 ethanol/dest water; acetone
Concentration / amount:
Pilot: 100% (without vehicle), 50%, 25%, 10%, 5%, 2.5%, 1%, 0.5% (partly in 80/20 ethanol/dest water)
Main study Induction: 5% (in 80/20 ethanol/dest water)
Challenge: 2.5% (in acetone)
No. of animals per dose:
Main study test group: 10 males and 10 females
Main study control group: 5 males and 5 females
Details on study design:
RANGE FINDING TESTS:
Primary irritation 8 male and 8 female animals were used.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6h
- Frequency of applications: once a week
- Concentrations: 5%

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: two weeks after last induction exposure
- Exposure period: 6h
- Test groups: 10 animals per gender
- Control group: 5 animals per gender
- Concentrations: 2.5%
- Evaluation (hr after challenge): 24hr
Challenge controls:
5 animals per gender were used as control, no positive control is reported
Positive control substance(s):
no

Study design: in vivo (LLNA)

Statistics:
no

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
2.5%
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: 2.5%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
2.5%
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: 2.5%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
2.5%
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: 2.5%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
2.5%
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: 2.5%. No with. + reactions: 0.0. Total no. in groups: 10.0.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
Only grade ± reactions compareable to the controls were observed. The test substance is considered to be not sensitising.
Executive summary:

The potential of Confidential test item name, as a 5% w/v formulation in 80% ethanol/20% distilled water, to produce delayed contact hypersensitivity in guinea pigs was evaluated using an adaptation of the method of Ritz and Buehler*.

Following primary challenge, there were no grades of 1 produced in the test or control animals. The incidence of grade + responses in the test group (14 of 20) was compared to that of the naive control group (7 of 10). The incidence and severity of these responses in the test group were essentially comparable to those produced by the naive control group indicating that sensitization had not been induced.