Quaternary ammonium compounds, (C16-18 and C18-unsatd. alkyl)trimethyl, chlorides

Endpoint summary

Description of key information

Based on the results of the study with a structurally similar substance, the registered substance is not considered to be sensitising to skin.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Reference

Reference 1

Endpoint:

skin sensitisation: in vitro

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

an in vitro skin sensitisation study does not need to be conducted because the available in vitro test methods are not applicable for the substance and therefore an in vivo skin sensitisation study was conducted

Reason / purpose for cross-reference:

data waiving: supporting information

Reference 2

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From September 26, 1994 to November 24, 1994

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

Information on the category justification can be found in the Quaternary ammonium salts (QAS) category and section 13.2 of IUCLID.

Qualifier:

according to guideline

Guideline:

EU Method B.6 (Skin Sensitisation)

Qualifier:

according to guideline

Guideline:

OECD Guideline 406 (Skin Sensitisation)

GLP compliance:

yes

Type of study:

Buehler test

Justification for non-LLNA method:

Before LLNA method implementation

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: 227 - 299 g (average 269 g)
- Housing: in groups of 5 in Type 4 macrolon cages
- Diet (e.g. ad libitum): Altromin diet for guinea pigs, Altromin GmbH, Lage/Lippe, Germany
- 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

Route:

epicutaneous, occlusive

Vehicle:

water

Concentration / amount:

For the determination of a non-irritating concentration: 0.1, 1.0, 4.0, 20.0 and 100.0% w/v
Dermal induction: 4% w/v
Challenge: 1% w/v

Route:

epicutaneous, occlusive

Vehicle:

water

Concentration / amount:

For the determination of a non-irritating concentration: 0.1, 1.0, 4.0, 20.0 and 100.0% w/v
Dermal induction: 4% w/v
Challenge: 1% w/v

No. of animals per dose:

20 for treated group
10 for controls

Details on study design:

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

Positive control substance(s):

no

Key result

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

Dose level:

1% in water

No. with + reactions:

0

Total no. in group:

20

Remarks on result:

no indication of skin sensitisation

Remarks:

((evaluation of erythema and edema on Day 30)

Key result

Reading:

2nd reading

Hours after challenge:

48

Group:

test chemical

Dose level:

1% in water

No. with + reactions:

0

Total no. in group:

20

Remarks on result:

no indication of skin sensitisation

Remarks:

(evaluation of erythema and edema on Day 31)

Key result

Reading:

1st reading

Hours after challenge:

24

Group:

negative control

No. with + reactions:

0

Total no. in group:

10

Remarks on result:

no indication of skin sensitisation

Remarks:

(evaluation of erythema and edema on Day 30)

Key result

Reading:

2nd reading

Hours after challenge:

48

Group:

negative control

No. with + reactions:

0

Total no. in group:

10

Remarks on result:

no indication of skin sensitisation

Remarks:

(evaluation of erythema and edema on Day 31)

Reading:

other:

Group:

positive control

Remarks on result:

not measured/tested

Determination of a non-irritating concentration

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

The doses of 4 and 1% w/v 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 edema. 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.

Interpretation of results:

other: CLP criteria not met

Conclusions:

Under the study conditions, the source substance was considered to be non-sensitizing.

Executive summary:

A study was conducted to determine the sensitising potential of source substance, C16 TMAC (30% active in water) in guinea-pigs according to OECD Guideline 406 (Buehler method) and EU Method B6, in compliance with GLP. 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 source substance at 4% w/v via an occlusive bandage placed on the shaved skin of the left flank. After 6 hours, the bandage was removed and the skin was washed with warm tap water. Observations of the treated skin were made approximately 24 hours later. On Day 29, the test and control animals were exposed to 0.5 mL of the source substance at 1% w/v 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 dermal induction phase (Days 1-5), animals presented light to clearly defined erythema and very light edema. In the control group, no effects were seen on the treated skin. In the challenge phase, 24 and 48 hours 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 were comparable to that of the controls. Under the study conditions, the source substance was considered to be non-sensitising (Bury D, 1994).

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

A study was conducted to determine the sensitising potential of source substance, TMAC C16 (30% active in water) in guinea-pigs according to OECD Guideline 406 (Buehler method) and EU Method B6, in compliance with GLP. 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 source substance at 4% w/v via an occlusive bandage placed on the shaved skin of the left flank. After 6 hours, the bandage was removed, and the skin was washed with warm tap water. Observations of the treated skin were made approximately 24 hours later. On Day 29, the test and control animals were exposed to 0.5 mL of the source substance at 1% w/v 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 dermal induction phase (Days 1-5), animals presented light to clearly defined erythema and very light edema. In the control group, no effects were seen on the treated skin. In the challenge phase, 24 and 48 hours 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 were comparable to that of the controls. Under the study conditions, the substance was considered to be non-sensitising (Bury D, 1994). Based on the results of the source study, the registered substance is also considered to be non-sensitising to skin.

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

Based on the results of the study with a structurally similar substance, the registered substance does not warrant a classification for skin sensitisation according to EU CLP criteria (Regulation EC 1272/2008).