Quaternary ammonium compounds, C18-22 (even numbered) alkyltrimethyl, chlorides; Docosyltrimethylammonium chloride; C18-22 TMAC

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From January 16, 1995 to April 18, 1995

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

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:

1995

Report date:

1995

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EU Method B.6 (Skin Sensitisation)

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 406 (Skin Sensitisation)

GLP compliance:

yes

Type of study:

Buehler test

Justification for non-LLNA method:

A Buehler test was already available on the structurally similar substance.

Test material

Test material information

Constituent 1

Reference substance name:

Trimethyloctadecylammonium chloride

EC Number:

203-929-1

EC Name:

Trimethyloctadecylammonium chloride

Cas Number:

112-03-8

Molecular formula:

C21H46NCl

IUPAC Name:

N,N,N-trimethyloctadecan-1-aminium chloride

Test material form:

solid

Specific details on test material used for the study:

- Physical state: White to yellowish flakes
- Analytical purity: 79.8%
- Lot/batch No.: E061859561, produced on 31-05-1994

In vivo test system

Test animals

Species:

guinea pig

Strain:

other: Pirbright-White

Sex:

female

Details on test animals and environmental conditions:

TEST ANIMALS
- Source: Hoechst AG, Kastengrund, SPF breeding
- Weight at study initiation: 311 - 363 g (average 339 g)
- Housing: in groups of 5 in Type 4 macrolon cages
- Diet (e.g. ad libitum): ssniff Ms-H (V2233), ad libitum
- Water (e.g. ad libitum): tap water ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 23°C
- Humidity (%): 40 - 70%
- Photoperiod (hrs dark / hrs light): 12/12

Study design: in vivo (non-LLNA)

Induction

Route:

epicutaneous, occlusive

Vehicle:

water

Concentration / amount:

For the determination of a non-irritating concentration: 0.04, 0.2, 1.0, 4.0, 20.0 (in ethanol:water / 80:20) and 100.0%
Dermal induction: 4%
Challenge: 1%

Challenge

Route:

epicutaneous, occlusive

Vehicle:

water

Concentration / amount:

For the determination of a non-irritating concentration: 0.04, 0.2, 1.0, 4.0, 20.0 (in ethanol:water / 80:20) and 100.0%
Dermal induction: 4%
Challenge: 1%

No. of animals per dose:

6 for determination of non-irritating concentration
20 for treated group
10 for controls

Positive control substance(s):

no

Results and discussion

In vivo (non-LLNA)

Results

Results 1

Key result

Remarks on result:

no indication of skin sensitisation

Remarks:

See below for details on results

Results 2

Key result

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

Dose level:

1%

No. with + reactions:

0

Total no. in group:

20

Remarks on result:

no indication of skin sensitisation

Results 3

Key result

Reading:

2nd reading

Hours after challenge:

48

Group:

test chemical

Dose level:

1%

No. with + reactions:

0

Total no. in group:

20

Remarks on result:

no indication of skin sensitisation

Results 4

Key result

Reading:

1st reading

Group:

positive control

Remarks on result:

not measured/tested

Results 5

Key result

Reading:

1st reading

Group:

negative control

Remarks on result:

not measured/tested

Any other information on results incl. tables

Determination of a non-irritating concentration

Exposure of guinea pig skin to 100 or 20% test substance resulted in moderate erythema and clearly defined edema. At 4%, the animals showed light / clearly defined erythema and very light edema. There were no signs of irritation at 1, 0.2 and 0.04%.

The doses of 4 and 1% were therefore selected for the induction and challenge phases, respectively.

Dermal induction phase

During the induction phase (Days 1 - 15), animals presented light to clearly defined erythema and very light to clearely defined edema. The skin surfaces were dry and flaky. In the control group, no effects were seen on the treated skin.

Challenge phase

24 and 48 h after the occlusive bandage was removed, no effects were observed in any animals of the treated or control groups.

Clinical signs and bodyweight

During the main test, there were no signs of toxicity and bodyweight gain of the test animals was comparable to that of controls.

Applicant's summary and conclusion

Interpretation of results:

other: CLP criteria not met

Remarks:

does not qualify classification

Conclusions:

Under the conditions of the Buehler test, the substance is considered to be non-sensitizing.

Executive summary:

A study was conducted to determine the sensitization potential of the test substance, C18 TMAC (active: 79.8%), according to OECD Guideline 406 and EU Method B.6, in compliance with GLP. The experiment was performed in guinea-pig according to the Buehler test. A pre-test was conducted to determine the non-irritating concentrations to use in the main study. During the induction phase (Days 1 - 15), the test animals were exposed to 0.5 mL of the read across substance at 4% via an occlusive bandage placed on the shaved skin of the left flank. After 6 h, the bandage was removed and the skin was washed with warm tap water. Observations of the treated skin were made approximately 24 h later. On Day 29, the test and control animals were exposed to 0.5 mL of the test substance at 1% via an occlusive bandage placed on the shaved skin of the right flank. On Days 30 and 31, a macroscopic evaluation of the treated skin was made and animal bodyweights were recorded. During the induction phase (Days 1 - 15), animals presented light to clearly defined erythema and very light to clearly defined edema. The skin surfaces were dry and flaky. In the control group, no effects were seen on the treated skin. In the challenge phase, 24 and 48 h after the occlusive bandage was removed, no effects were observed in any animals of the treated or control groups. During the main test, there were no signs of toxicity and bodyweight gain of the test animals was comparable to that of controls. Under the study conditions, the test substance was considered to be non-sensitizing to guinea pig (Bury, 1995).