Piperidin-4-ol

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Justification for type of information:

data is from handbook or collection of data

Data source

Reference

Reference Type:

other: Authorative Database

Title:

oral toxicity in mouse for CAS no: 75-75-2

Author:

HSDB

Year:

2017

Bibliographic source:

U.S. National Library of Medicine, National Institutes of Health, Health & Human Services, 2017

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: as mentioned below

Principles of method if other than guideline:

The dermal sensitization potential of Dibutylamine (CAS no: 111-92-2) was evaluated in 10 CF1(BR) mice by using Mouse Ear Swelling Test (Sensitization Assay).

GLP compliance:

not specified

Type of study:

mouse ear swelling test

Justification for non-LLNA method:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

1-Butanamine, N-butyl-

Cas Number:

111-92-2

Molecular formula:

C8H19N

IUPAC Name:

1-Butanamine, N-butyl-

Test material form:

liquid

Details on test material:

- Name of test material (as cited in study report): Di-n-Butylamine
- Molecular formula: C8H19N
- Molecular weight: 129.245 g/mol
- Substance type: organic
- Physical state: liquid
- Smiles: N(CCCC)CCCC
-InChI: 1S/C8H19N/c1-3-5-7-9-8-6-4-2/h9H,3-8H2,1-2H3

Specific details on test material used for the study:

- Name of test material (as cited in study report): Di-n-Butylamine
- Molecular formula: C8H19N
- Molecular weight: 129.245 g/mol
- Substance type: organic
- Physical state: liquid
- Smiles: N(CCCC)CCCC
-InChI: 1S/C8H19N/c1-3-5-7-9-8-6-4-2/h9H,3-8H2,1-2H3

In vivo test system

Test animals

Species:

mouse

Strain:

other: CF1(BR)

Sex:

not specified

Details on test animals and environmental conditions:

No data available

Study design: in vivo (non-LLNA)

Induction

Route:

other: epicutaneous

Vehicle:

other: Ethanol

Concentration / amount:

0.1% (0.1mL)

Day(s)/duration:

3 days

Adequacy of induction:

not specified

Challenge

No.:

#1

Route:

other: epicutaneous

Vehicle:

other: Ethanol

Concentration / amount:

48-hour

Day(s)/duration:

0.25% (0.01mL)

Adequacy of challenge:

not specified

No. of animals per dose:

10

Details on study design:

RANGE FINDING TESTS:

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 48-hour
- Test groups: 10
- Control group:10
- Site: clipped abdomens
- Frequency of applications: daily for 3 days
- Duration: 3 days
- Concentrations: 0.1% (0.1mL)

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: after 7 days
- Exposure period: 48-hour
- Test groups: 10
- Control group: 10
- Site: to both dorsal and ventral surfaces of the left ears
- Concentrations: 0.25% (0.01mL)
- Evaluation (hr after challenge): after 48 hours

C.RECHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: after 7 days
- Exposure period: 48-hour
- Test groups: 10
- Control group: 10
- Site: to both dorsal and ventral surfaces of the left ears
- Concentrations: 0.25% (0.01mL)
- Evaluation (hr after challenge): after 48 hours

Challenge controls:

During challenge, 0.01 ml dermal applications of a 25% (v/v) solution to both dorsal and ventral surfaces of the right ears served as control.

Positive control substance(s):

yes

Remarks:

A group of 10 mice likewise inducted over 3 days with 0.1 ml dermal applications of 0.5% (w/v) DNCB served as the positive control

Results and discussion

In vivo (non-LLNA)

Results

Reading:

1st reading

Hours after challenge:

48

Group:

test chemical

Dose level:

0.25% (0.01mL)

No. with + reactions:

0

Total no. in group:

10

Clinical observations:

None of either test or irritation control groups had responded to challenge.

Remarks on result:

no indication of skin sensitisation

In vivo (LLNA)

Cellular proliferation data / Observations:

One animal challenged with di-n-butylamine exhibited a positive sensitization response (20% increase in ear thickness over control) at 48-hour evaluation only. None of either test or irritation control groups had responded to challenge by the 24-hour evaluation and none responded to rechallenge.

Applicant's summary and conclusion

Interpretation of results:

other: Not sensitizing

Conclusions:

None of either test or irritation control groups had responded to challenge by the 24-hour evaluation and none responded to rechallenge. Hence the chemical Dibutylamine (CAS no: 111-92-2) was considered as not skin sensitizing in Mouse Ear Swelling Test (Sensitization Assay).

Executive summary:

The dermal sensitization potential of Dibutylamine (CAS no: 111-92-2) was evaluated in 10 CF1(BR) mice by using Mouse Ear Swelling Test (Sensitization Assay).

 

Each mice was induced topically daily for 3 days at 0.1 ml of a 0.1% (v/v in ethanol) test solution to clipped abdomens. A group of 10 mice likewise inducted over 3 days with 0.1 ml dermal applications of 0.5% (w/v) DNCB served as the positive control. inducted over 3 days with 0.1 ml dermal applications of 0.5% (w/v) DNCB served as

 

Challenge and rechallenge were administered 7 and 14 days later in 0.01 ml dermal applications of a 25% (v/v) solution to both dorsal and ventral surfaces of the left and right ears respectively of inducted test mice. The thickness of treated left ears relative to that of solvent control (ethanol) right ears indicated the degree of sensitization. One animal challenged with di-n-butylamine exhibited a positive sensitization response (20% increase in ear thickness over control) at 48-hour evaluation only.

 

None of either test or irritation control groups had responded to challenge by the 24-hour evaluation and none responded to rechallenge. Conversely, 60% and 50% positive response in the DCNB-inducted and challenged groups at 24-hour and 48-hour evaluations, respectively, confirmed the validity of the test system.

 

Hence the chemical Dibutylamine (CAS no: 111-92-2) was considered as not skin sensitizing in Mouse Ear Swelling Test (Sensitization Assay).