Reaction mass of pentadecylamine and tridecylamine and 2-Methyldodecylamine and 2-Methyltetradecylamine

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Comparable to guideline study, limited documentation, acceptable for assessment

Data source

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

1975

Report date:

1975

Reference 2

Reference Type:

other: Summary report

Title:

Unnamed

Year:

1978

Report date:

1978

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 406 (Skin Sensitisation)

Deviations:

yes

Remarks:

no positive control group included / reduced minimal number of animals in the negative control group used (4 instead of 5 - 10)

Principles of method if other than guideline:

according to Magnusson B and Kligman AM (1970) in "Allergic Contact Dermatitis in the Guinea-Pig: Identification of contact allergens", Springfield, Illinois/USA

GLP compliance:

no

Type of study:

guinea pig maximisation test

Justification for non-LLNA method:

Study was performed before LLNA method was established.

Test material

Test material information

Constituent 1

Reference substance name:

Amines, C12-18-alkyl

EC Number:

268-953-7

EC Name:

Amines, C12-18-alkyl

Cas Number:

68155-27-1

Molecular formula:

mixture of C13 [C13H29N] and C15 [C15H33N]-branched and linear amines

IUPAC Name:

Amines, C12-18-alkyl

Details on test material:

- Name of test material (as cited in study report): Synprolam 35 (trade name)
- Substance type: organic
- Physical state: liquid, clear
- Melting point: 12.5 °C
- Boiling point: 263 °C
- Density: 0.806 g/mL (20 °C)
- Analytical purity: no data
- Melting point: 12.5 °C
- Boiling point: 263 °C
- Density: 0.806 g/mL (20 °C)
- Impurities (identity and concentrations): no data
- Composition of test material, percentage of components: no data in the Report
data adopted from the precursor aldehyde mixture (SYNPRAL 135):
- n-tridecylamine 33 % (m/m)
- isotridecylamine 33 % (m/m)
- n-pentyldecylamine 14 % (m/m)
- isopentylamine 14 % (m/m)
- other components 6 % (m/m)

[Reference: ICI 1975/1976: Synthetic fatty amines - Synpral 135 (Synprolaldehyde; C13/C15 alkyl aldehyde). MSDS]

In vivo test system

Test animals

Species:

guinea pig

Strain:

Dunkin-Hartley

Sex:

male

Details on test animals and environmental conditions:

TEST ANIMALS
- Source: Redfern Animal Breeders Ltd., Brenchley/Kent
- Age at study initiation: no data
- Weight at study initiation: no data
- Housing: suspended cages with a wire-mesh floor
- Diet: ad libitum
- Water: ad libitum

Study design: in vivo (non-LLNA)

Induction

Induction 1

Route:

intradermal

Vehicle:

paraffin oil

Induction 2

Concentration / amount:

induction/i.d.: 0.1 % (v/v); induction/topical: 5 % (v/v)
challenge/topical 0.5 % (v/v)

Challenge

Challenge 1

Route:

epicutaneous, occlusive

Vehicle:

paraffin oil

Challenge 2

Concentration / amount:

induction/i.d.: 0.1 % (v/v); induction/topical: 5 % (v/v)
challenge/topical 0.5 % (v/v)

No. of animals per dose:

20 (test); 4 (control)

Details on study design:

RANGE FINDING TESTS:
Test on intradermal and topical irritancy

B. CHALLENGE EXPOSURE
- No. of exposures:
- Day(s) of challenge:
- Exposure period:
- Test groups:
- Control group:
- Site:
- Concentrations:
- Evaluation (hr after challenge):


MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 1x i.d.; 1x topical
- Exposure period: i.d. followed by 1 wk rest period; topical: 48 h , followed by 14 d rest period
- Test group: 3 pairs of i.d. injections (A. Freund´s complete adjuvant / B. TS in liquid paraffin / C. Combination of A. and B.)
Topical application: 2x4 cm strip of Whatman No.1 MM paper soaked with the TS in paraffin, placed over the injection sites.
- Control group: one (4 animals) - no induction treatment (no details given)
- Site: interscapular area (right and left flank)
- Duration: 3 weeks
- Concentrations: 0.1 % (i.d.); 5 % (topical)


B. CHALLENGE EXPOSURE
- No. of exposures: 1x
- Day(s) of challenge: day 21
- Exposure period: 24 h
- Test groups: 2x2 cm Whatman No.1 MM paper soaked with the TS in paraffin applied to the the untreated right flank,
another paper without TS applied to the untreated left flank.
- Control group: analogous to the test group
- Site: see above
- Concentrations: 0.5 % (v/v)
- Evaluation (hr after challenge): 24, 48, and 72 h


OTHER:

Positive control substance(s):

no

Results and discussion

Positive control results:

no data

In vivo (non-LLNA)

Results

Results 1

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

Dose level:

0.5 %

No. with + reactions:

0

Total no. in group:

20

Clinical observations:

none

Remarks on result:

other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.5 %. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.

Results 2

Reading:

2nd reading

Hours after challenge:

48

Group:

test chemical

Dose level:

0.5 %

No. with + reactions:

0

Total no. in group:

20

Clinical observations:

none

Remarks on result:

other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.5 %. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.

Results 3

Reading:

1st reading

Hours after challenge:

24

Group:

negative control

Dose level:

0.5 %

No. with + reactions:

0

Total no. in group:

4

Clinical observations:

none

Remarks on result:

other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0.5 %. No with. + reactions: 0.0. Total no. in groups: 4.0. Clinical observations: none.

Results 4

Reading:

2nd reading

Hours after challenge:

48

Group:

negative control

Dose level:

0.5 %

No. with + reactions:

0

Total no. in group:

4

Clinical observations:

none

Remarks on result:

other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0.5 %. No with. + reactions: 0.0. Total no. in groups: 4.0. Clinical observations: none.

Results 5

Reading:

other:

Group:

positive control

Total no. in group:

0

Remarks on result:

not measured/tested

Any other information on results incl. tables

Induction

I.d. injections of FCA both alone and mixed with the TS elicited slight dermal irritation (data not shown). No dermal irritation was observed following i.d. injections of the TS (0.1% in paraffin oil) alone.

Reactions produced by the topically applied TS (5 % in paraffin oil) were obscured by the i.d. reactions which were still present at that time.

Challenge

no dermal irritation occurred on either flank of any of the test and control animals.

Applicant's summary and conclusion

Interpretation of results:

not sensitising

Remarks:

Migrated information

Conclusions:

Under the conditions of this test the test substance did not show sensitising properties.

Executive summary:

The sensitizing properties of the test substance were investigated in a Magnusson & Kligman test according to OECD Guideline 406. Intradermal induction was performed with 0.1% v/v test substance while 5% v/v in liquid parrafin was used for topical application. No dermal irritation was observed following intradermal injections alone. Reactions produced by the topical application were obscured by the intradermal reactions which were still present at this time. The animals were challenged topically two weeks after the induction period using 0.5% v/v in liquid paraffin. No dermal irritation occured on either flank of any of the guinea-pigs during the challenge period. There was, therefore, no evidence of delayed-type skin sensitivity.