Registration Dossier

Toxicological information

Skin sensitisation

Currently viewing:

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1984-02-27 To: 1984-03-30
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: According to OECD Guideline 406 (Skin Sensitisation), GLP
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984
Report Date:
1984

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
yes
Remarks:
Acclimation period is 4 days instead of 5 days. Pre and post study body weight not mentioned in the report
Principles of method if other than guideline:
Not applicable
GLP compliance:
yes
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): P1655 (C10-16 alkyldimethyl amine, N-oxides)
- Molecular formula (if other than submission substance): Not available
- Molecular weight (if other than submission substance): 235.7
- Substance type: Pure active substance
- Physical state: Liquid
- Analytical purity: Not available
- Impurities (identity and concentrations): None
- Composition of test material, percentage of components: see below
- Isomers composition: Not available
- Purity test date: Not available
- Lot/batch No.: Not available
- Expiration date of the lot/batch: see below
- Stability under test conditions: Not available
- Storage condition of test material: 40 °F and polyethylene bottle

In vivo test system

Test animals

Species:
guinea pig
Strain:
Hartley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Murphy Breeding Laboratories, Inc
- Age at study initiation: Not available
- Weight at study initiation: Not available
- Housing: As per the S.O.P.
- Diet (e.g. ad libitum): As per the S.O.P.
- Water (e.g. ad libitum):As per the S.O.P.
- Acclimation period: at least 4 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): As per the S.O.P.
- Humidity (%): As per the S.O.P.
- Air changes (per hr): As per the S.O.P.
- Photoperiod (hrs dark / hrs light):As per the S.O.P.


IN-LIFE DATES: From: 1984-02-27 To: 1984-03-30

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
One group of 20 test animals was treated with 0.4ml of 2% w/v of P1655 in distilled water for a period of 6 hours weekly for 3 induction exposure.
Test group and 10 control animals were challenged with 1% w/v of test material in distilled water .
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
One group of 20 test animals was treated with 0.4ml of 2% w/v of P1655 in distilled water for a period of 6 hours weekly for 3 induction exposure.
Test group and 10 control animals were challenged with 1% w/v of test material in distilled water .
No. of animals per dose:
20 animals in the test substance group and 10 animals in the vehicle control were treated with 0.4ml of 1% w/v of test material in distilled water .
Details on study design:
RANGE FINDING TESTS: Four animals were exposed for 6 hours period to various concentrations of the test substance
Concentration: 10%, 5%, 2% and 1% w/v P1655 in distilled water
Exposure period: 6 hours
Grading: the patch site were scored for irritation 24 and 48 hours following 6 hour patch application


MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3 induction exposure
- Exposure period: 6 hours
- Test groups: 0.4 ml of 2% w/v aqueous solution
- Control group: none
- Site: left shoulder of each animal
- Frequency of applications: once a week for 3 weeks
- Duration: 6 hours under occlusion
- Concentrations: 0.4 ml of 2% w/v aqueous solution of P1655

B. CHALLENGE EXPOSURE
- No. of exposures: one 6 hour exposure
- Day(s) of challenge: two weeks after third induction exposure
- Exposure period: 6 hours under occlusion
- Test groups: 1% w/v aqueous solution
- Control group: 1% w/v aqueous solution
- Site: left posterior quadrant of the side and back of the test animal
- Concentrations: 1% w/v aqueous solution of P1655
- Evaluation (hr after challenge): 24 and 48 hours after challenge exposure


OTHER: none
Challenge controls:
10 animals treated with 1% w/v of P1655 in distilled water .
Positive control substance(s):
no

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
1% w/v of test material in distilled water
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
No animal with positive response
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 1% w/v of test material in distilled water . No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: No animal with positive response.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
1% w/v of test material in distilled water
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no animals with positive responses
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 1% w/v of test material in distilled water . No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no animals with positive responses.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
1% w/v of test material in distilled water
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
no animals with positive responses
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 1% w/v of test material in distilled water . No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no animals with positive responses.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
1% w/v of test material in distilled water
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no animals with positive responses
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 1% w/v of test material in distilled water . No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no animals with positive responses.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
P1655 (30.4%) C10-16 alkyldimethylamine, N-Oxides did not induce sensitization in the guinea pig model.
Executive summary:

One group of 20 test animals was treated with 2% w/v of P1655 (30.4% active C10 -16 alkyldimethyl amine N-oxides) in distilled water for a period of 6 hours weekly for 3 induction exposures. The test animals and control animals were challenged with 1% w/v of P1655 in distilled water. At primary challenge, no skin reactions were observed in the test and control animals at the concentration of 1% w/v of P1655 in distilled water. Therefore, it was concluded that  30.4% C10-C16 alkyldimethylamine, N-Oxide is not a skin sensitizer.