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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
Study period:
March - April 1990
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study
Remarks:
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
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
Buehler test
Deviations:
no
GLP compliance:
yes
Type of study:
Buehler test
Justification for non-LLNA method:
The LLNA method was not established yet by the time the study was conducted.

Test material

Constituent 1
Reference substance name:
67359-57-3
EC Number:
614-052-2
Cas Number:
67359-57-3
IUPAC Name:
67359-57-3
Test material form:
liquid
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: room temperature
- Today handle under EC 909-125-3 Reaction mass of N,N-Dimethyldecan-1-amide and N,N-Dimethyloctan-1-amide.
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Lot/batch No.of test material: not specified

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature

FORM AS APPLIED IN THE TEST (if different from that of starting material): diluted in 80% ethanol/ 20% distilled water (induction) or in acetone (challenge)

In vivo test system

Test animals

Species:
guinea pig
Strain:
Hartley
Remarks:
albino
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Murphy
- Weight: 374-623g
- Housing: individually
- Diet: ad libitum, PURINA GUINEA PIG CHOW
- Water: ad libitum
- Acclimation period: at least four days

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

Study design: in vivo (non-LLNA)

Induction
Route:
epicutaneous, occlusive
Vehicle:
other: 80/20 ethanol/dest water
Concentration / amount:
5% (in 80/20 ethanol/dest water)
Challenge
Route:
epicutaneous, occlusive
Vehicle:
other: acetone
Concentration / amount:
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:
Irritation screening tests (pilots) with 8 male and 8 female animals were conducted. The several concentrations of the test substance (diluted in the same vehicle as used in the main study) were applied to the clipped skin of the animals backs (occlusive coverage). After approx. 6 h the chambers with the test solution were removed. 24 and 48 h after the treatment, the animals were examined for any irritating effects. Based on the results of these pilots a concentration of 5% test substance in 80% ethanol/ 20% distilled water, which caused slight to moderate patchy erythema, was used for the induction phase of the main study. As concentration for the challenge exposure, 2.5% test substance in acetone (highest non-irritating dose) was chosen.

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

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 12 - 16 days after last induction exposure
- Exposure period: 6 h
- Test groups: 10 animals per gender
- Control group: 5 animals per gender
- Concentrations: 2.5%
- Evaluation (hr after challenge): 24hr + 48hr
Challenge controls:
5 animals per gender were used as control, no positive control is reported
Positive control substance(s):
no

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
2.5%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
2.5%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
no indication of skin sensitisation
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:
no indication of skin sensitisation
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:
no indication of skin sensitisation

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Only slight reactions comparable to the controls were observed. The test substance is considered to be not sensitising.
Executive summary:

The potential of the test substance, 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 simialr to the OECD guideline 406

Following primary challenge, there were no grades of 1 produced in the test or control animals. The incidence of slight responses in the test group (13 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.