Amines, C12-18-alkyldimethyl, N-oxides

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

migrated information: read-across based on grouping of substances (category approach)

Adequacy of study:

key study

Study period:

1984-02-27 To: 1984-03-30

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: According to OECD Guideline 406 (Skin Sensitisation), GLP

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

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

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

Test material information

Constituent 1

Reference substance name:

308062-28-4

EC Number:

608-528-9

Cas Number:

308062-28-4

IUPAC Name:

308062-28-4

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)

Induction

Induction 1

Route:

epicutaneous, occlusive

Vehicle:

water

Induction 2

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 .

Challenge

Challenge 1

Route:

epicutaneous, occlusive

Vehicle:

water

Challenge 2

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)

Results

Results 1

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

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.

Results 2

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.

Results 3

Reading:

2nd reading

Hours after challenge:

48

Group:

test chemical

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.

Results 4

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.