Reaction products of C16-18 (even numbered), C18 unsaturated alkylamines with C10-13 alkylbenzenesulfonic acid

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

March 2013 - July 2013

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)

Deviations:

no

GLP compliance:

yes

Type of study:

mouse local lymph node assay (LLNA)

Test material

Test material information

1

Reference substance name:

Reaction products of C16-18 (even numbered), C18 unsaturated alkylamines with C10-13 alkylbenzenesulfonic acid

EC Number:

701-164-2

IUPAC Name:

Reaction products of C16-18 (even numbered), C18 unsaturated alkylamines with C10-13 alkylbenzenesulfonic acid

Test material form:

liquid: viscous

Details on test material:

Chemical registery number : 701-164-2
Chemical name : Reaction products of C16-18 (even numbered), C18 unsaturated alkylamines with C10-13 alkylbenzenesulfonic acid

Based on the qualitative and quantitative information on the composition, the sample used are representative of the boundary composition shared and agreed by each registrant.

In vivo test system

Test animals

Species:

mouse

Strain:

CBA

Sex:

female

Details on test animals and environmental conditions:

TEST ANIMALS
- Source: Harlan Laboratories UK Ltd., Oxon, UK.
- Age at study initiation: eight to twelve weeks old
- Weight at study initiation: 15 to 23 g
- Housing: The animals were individually housed in suspended solid floor polypropylene cages furnished with softwood woodflakes.
- Diet (e.g. ad libitum): Free access to mains food was allowed throughout the study.
- Water (e.g. ad libitum): Free access to mains tap water was allowed throughout the study.
- Acclimation period: at least five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25°C
- Humidity (%): 30 to 70%
- Air changes (per hr): approximately fifteen changes per hour
- Photoperiod (hrs dark / hrs light): twelve hours continuous light (06.00 to 18.00) and twelve hours darkness

Study design: in vivo (LLNA)

Vehicle:

acetone/olive oil (4:1 v/v)

Concentration:

5%, 10% and 25% v/v.

No. of animals per dose:

Preliminary screening test: 2 female mice
1 at 25% v/v and 1 at 50% v/v.

Main test:
5%: 4 female mice
10%: 4 female mice
25%: 4 female mice

Details on study design:

RANGE FINDING TESTS:
- Irritation: The mouse treated at a concentration of 50% v/v in acetone/olive oil 4:1 showed signs of toxicity on Day 2 including haunched posture, lethargy and ptosis.
- Irritation: No signs of systematic toxicity or irritation indicated by an equal to or greater than 25% increase in mean ear thickness were noted in the mouse at a concentration of 25% v/v in acetone/olive oil 4:1.
- Based on this information the dose level selected for the main test were 25%, 10% or 5% v/v in acetone/olive oil 4:1.

MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: Estimation of the proliferation response of lymph node cells.
- Criteria used to consider a positive response: The stimulation index is expressed as the mean radioactive incorporation treatment group divided by the mean radioactive incorporation of the vehicle control group. The test material will be regarded as a sensitizer if at least one concentration of the test material results in a threefold or greater increase in 3HTdR incorporation compared to control values. Any test material failing to produce a threefold or greater increase in 3HTdR incorporation will be classified as a "non-sensitizer."

TREATMENT PREPARATION AND ADMINISTRATION:
Groups of four mice were treated at concentrations of 25%, 10% or 5% v/v in acetone/olive oil 4:1. The preliminary screening test suggested that the test material would produce a systemic toxicity response or excessive local skin irritation at a concentration of 50% v/v. The mice were treated by daily application of 25 µL of the appropriate concentration of the test material to the dorsal surface of each ear for three consecutive days (Days 1, 2, 3). The test material formulation was administered using an automatic micropipette and spread over the dorsal surface of the ear using the tip of the pipette.
A further group of four mice received the vehicle alone in the same manner.

Results and discussion

In vivo (LLNA)

Results

Results 1

Key result

Parameter:

SI

Value:

4.52

Test group / Remarks:

5% (v/v) in acetone/olive oil 4:1

Results 2

Key result

Parameter:

SI

Value:

6.49

Test group / Remarks:

10% (v/v) in acetone/olive oil 4:1

Results 3

Key result

Parameter:

SI

Value:

7.63

Test group / Remarks:

25% (v/v) in acetone/olive oil 4:1

Any other information on results incl. tables

There were no deaths. No signs of systemic toxicity were noted in the test or control animals during the test.

Body weight change of the test animals between Day 1 and Day 6 was comparable to those observed in the corresponding control group animals over the same period.

Applicant's summary and conclusion

Interpretation of results:

sensitising

Conclusions:

Test material was considered a sentitizer under the conditions of the study.

Executive summary:

Test material was considered a sentitizer under the conditions of the study.