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Administrative data

Description of key information

Based on the available read across data, C16-18 and C18-unsatd. TMAC is not considered to be a skin sensitiser.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin sensitisation: in vitro
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
read-across based on grouping of substances (category approach)
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:
Refer to the Quaternary ammonium salts (QAS) category or section 13 for details on the category justification. The study with the read across substance is considered sufficient to fulfil the information requirements as further explained in the provided endpoint summary.
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study
Qualifier:
according to
Guideline:
EU Method B.6 (Skin Sensitisation)
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
Buehler test
Justification for non-LLNA method:
Before LLNA method implementation
Specific details on test material used for the study:
- Name of test material (as cited in study report): Genamin CTAC
- Physical state: Clear colourless liquid
- Analytical purity: 28.7%
- Composition of test material, percentage of components: ca. 30% cetrimonium chloride, ca. 70% water
- Lot/batch No.: E06178641, produced on 26-07-1993
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
Positive control substance(s):
no
Key result
Remarks on result:
no indication of skin sensitisation

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:
Based on the results of the read across study, the test substance is considered to be non-sensitising in the Buehler test.
Executive summary:

A study was conducted to determine the sensitising potential of the read across substance, C16 TMAC (active ingredient 30%), 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 test 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 test 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 was comparable to that of the controls. Based on the results of the read across study, the test substance is considered to be non-sensitising in the Buehler test (Bury D, 1994).

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
read-across based on grouping of substances (category approach)
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
Justification for type of information:
Refer to the Quaternary ammonium salts (QAS) category or section 13 for details on the category justification. The study with the read across substance is considered sufficient to fulfil the information requirements as further explained in the provided endpoint summary.
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.6 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes
Type of study:
Buehler test
Justification for non-LLNA method:
Before LLNA method implementation
Specific details on test material used for the study:
- Physical state: White to yellowish flakes
- Analytical purity: 79.8%
- Composition of test material, percentage of components: ca. 80% steartrimonium chloride
- Lot/batch No.: E061859561, produced on 31-05-1994
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 - 363g (average 339g)
- 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: 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: 0.04, 0.2, 1.0, 4.0, 20.0 (in ethanol:water / 80:20) and 100.0%
Dermal induction: 4%
Challenge: 1%
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
Key result
Remarks on result:
other: see '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 48h 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:
Based on the results of the read across study, the test substance is considered to be non-sensitizing in a Buehler test.
Executive summary:

A study was conducted to determine the sensitization potential of the read across substance, C18 TMAC, 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 test 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. Based on the results of the read across study, the test substance is considered to be non-sensitizing in a Buehler test (Bury, 1995).

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

A study was conducted to determine the sensitising potential of the read across substance, C16 TMAC (active ingredient 30%), in guinea-pigsaccording 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 test 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 test 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 was comparable to that of the controls.Based on the results of the read across study, the test substance is considered to be non-sensitising in the Buehler test (Bury D, 1994).

A study was conducted to determine the sensitization potential of the read across substance, C18 TMAC, 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 test 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.Based on the results of the read across study, the test substance is considered to be non-sensitizing in a Buehler test (Bury, 1995).

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the available read across data, C16-18 and C18-unsatd. TMAC is not considered to be a skin sensitiser, therefore no classification is required for this endpoint according to CLP criteria (Regulation EC 1272/2008).