Benzyldimethyl(octadecyl)ammonium chloride

Endpoint summary

Description of key information

Based on the results of the read across study, the test substance C18 ADBAC, is considered to be non-sensitising to skin.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Reference

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Remarks:

Modified Draize test

Type of information:

read-across from supporting substance (structural analogue or surrogate)

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

Justification for type of information:

Refer to the section 13 of IUCLID dataset for details on the read across justification. The algae study with the read across substance is considered sufficient to fulfil the information requirements as further explained in the provided endpoint summary.

Reason / purpose for cross-reference:

read-across source

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.

Species:

guinea pig

Route:

intradermal

Vehicle:

water

Concentration / amount:

Induction 0.1% intracutaneous
Challenge 0.1% intracutaneous

Day(s)/duration:

1 day

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

Key result

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

Dose level:

0.1%

No. with + reactions:

0

Total no. in group:

6

Remarks on result:

other: See 'Any other information on results incl. tables'

Key result

Reading:

1st reading

Group:

negative control

Remarks on result:

not measured/tested

Key result

Reading:

1st reading

Group:

positive control

Remarks on result:

not measured/tested

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.

Interpretation of results:

other: CLP criteria not met

Remarks:

not classified

Conclusions:

Based on the results of the study, the test substance is considered to be non-sensitizing to guinea pig skin.

Executive summary:

A study was conducted to determine the skin sensitisation potential of the read across substance, C12 -16 ADBAC (active: 50%), according to a method similar 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 read across substance was cosidered to be non-sensitizing to guinea pig skin (Thomas, 1974). Based on the results of the read across study, a similar non-sensitising behaviour can be expected for the the test substance, C18 ADBAC.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information:

A study was conducted to determine the skin sensitisation potential of the read across substance, C12 -16 ADBAC (active: 50%), according to a method similar 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 read across substance was cosidered to be non-sensitizing to guinea pig skin (Thomas, 1974). Based on the results of the read across study, a similar non-sensitising behaviour can be expected for the test substance, C18 ADBAC.

Justification for classification or non-classification

Based on the results of the read across study, the test substance, C18 ADBAC, is concluded not to warrant classification for skin sensitisation according to EU CLP criteria (Regulation 1272/2008/EC).