Quaternary ammonium compounds, benzyl C12-C16 (even numbered)-alkyldimethyl chlorides

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Remarks:

Modified Draize test

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1974

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1974

Report date:

1974

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

EU Method B.6 (Skin Sensitisation)

Version / remarks:

Cited as Directive 84/449/EEC, B.6

Deviations:

no

GLP compliance:

no

Type of study:

other: Modification of the Draize technique (Draize, Woodward and Calvery 1944 NAS-NRC 1964).

Justification for non-LLNA method:

The Local Lymph Node Assay (LLNA; TG 429) was adopted in 2002.

Test material

Test material information

Constituent 1

Reference substance name:

N-benzyl-N,N-dimethyltetradecan-1-aminium chloride

EC Number:

939-253-5

Cas Number:

68424-85-1

Molecular formula:

C12-14H25-29-(CH3)2-C6H5-N.Cl

IUPAC Name:

N-benzyl-N,N-dimethyltetradecan-1-aminium chloride

Constituent 2

Reference substance name:

Water

EC Number:

231-791-2

EC Name:

Water

Cas Number:

7732-18-5

Molecular formula:

H2O

IUPAC Name:

water

Test material form:

liquid

In vivo test system

Test animals

Species:

guinea pig

Study design: in vivo (non-LLNA)

Induction

Route:

intradermal

Vehicle:

water

Concentration / amount:

Induction 0.1% intracutaneous
Challenge 0.1% intracutaneous

Day(s)/duration:

1 day

Challenge

Route:

intradermal

Vehicle:

water

Concentration / amount:

Induction 0.1% intracutaneous
Challenge 0.1% intracutaneous

Day(s)/duration:

1 day

No. of animals per dose:

6

Details on study design:

- 1st application: Induction 0.1 % intracutaneous
- 2nd application: Challenge 0.1 % intracutaneous
For the induction phase, 0.1 mL of a concentration of 0.1% of test substance in water was injected intradermally into the back of each six guinea pigs. This procedure was repeated every other days, using a different injection site on each occasion, until a total of nine injections had been given. Injection sites were examined 24h after each injection and scored for erythema and oedema using the Draize scale.
After completion of this series of priming injections the animals remained untreated for two weeks, and were then given a single challenge intradermal injection of the same concentration and volume as for induction. Injection sites were examined 24h after this challenge dose as before for erythema and oedema. The effects were compared to those produced by the priming doses in order to determine whether sensitisation had been produced.

Positive control substance(s):

no

Results and discussion

In vivo (non-LLNA)

Results

Results 1

Key result

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

Dose level:

0.1%

Remarks on result:

other: not sensitising

Remarks:

no greater erythema or edema reactions were produced in any animal following challenge (modified Draize test)) See result tables

Results 2

Key result

Reading:

1st reading

Group:

negative control

Remarks on result:

not measured/tested

Results 3

Key result

Reading:

1st reading

Group:

positive control

Remarks on result:

not measured/tested

Any other information on results incl. tables

Modified Draize test:

- The priming injections elicited very slight to well defined erythema, and very slight to slight oedma on all occasions.
- The challenge dose produced a well defined erythema and very slight oedema in all occasions.

As the challenge doses did not produce any greater reaction in any animal, it may be concluded that is not a sensitising agent under the conditions of this experiment.

For result tables, kindly refer to the attached background material section of the IUCLID.

Applicant's summary and conclusion

Interpretation of results:

other: CLP criteria not met

Remarks:

(not sensitising)

Conclusions:

Under the study conditions, the test substance was not considered sensitizing to guinea pig skin.

Executive summary:

A study was conducted to determine the skin sensitisation potential of the test substance, C12 -16 ADBAC (50% active in water) according to EU Method B.6 (modified Draize test). For the induction phase, 0.1 mL of 0.1% test substance in water was injected intradermally into the back of each six guinea pigs. This procedure was repeated every other day, using a different injection site on each occasion, until a total of nine injections had been given. Injection sites were examined 24 h after each injection and scored for erythema and oedema using the Draize scale. After a two week interval, a single challenge intradermal injection of the same concentration and volume was given as for induction. Injection sites were examined 24 h after this challenge dose as before for erythema and oedema. The effects were compared to those produced by the priming doses in order to determine whether sensitisation had been produced. The priming injections elicited very slight to well defined erythema, and very slight to slight oedema on all occasions. The challenge dose produced a well-defined erythema and very slight oedema in all occasions. However, the challenge doses did not produce any greater reaction in any animal. Under the study conditions, the test substance was not considered sensitizing to guinea pig skin (Thomas, 1974).