N,N,N-trimethylanilinium chloride

Endpoint summary

Description of key information

By applying the weight of evidence approach, the test chemical can be estimated to be not sensitizing to skin. Comparing the annotations with criteria of CLP regulation, the test chemical can be classified under the category "Not Classified".

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Reference

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

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

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Remarks:

Weight of evidence approach based on various test chemicals

Justification for type of information:

Weight of evidence approach based on various test chemicals

Reason / purpose for cross-reference:

read-across source

Reason / purpose for cross-reference:

read-across source

Reason / purpose for cross-reference:

read-across source

Qualifier:

according to guideline

Guideline:

other: Weight of evidence approach based on various test chemicals

Principles of method if other than guideline:

Weight of evidence approach based on various test chemicals

GLP compliance:

not specified

Type of study:

other: Weight of evidence approach based on various test chemicals

Justification for non-LLNA method:

not specified

Specific details on test material used for the study:

- Name of test material (as cited in study report): N,N,N-trimethylanilinium chloride
- Molecular formula: C9H14N.Cl
- Molecular weight: 171.67 g/mol
- Smiles notation: [Cl-].C[N+](C)(C)c1ccccc1
- InChl : InChI=1/C9H14N.ClH/c1-10(2,3)9-7-5-4-6-8-9;/h4-8H,1-3H3;1H/q+1;/p-1
- Substance type: Organic
- Physical state: Solid

Species:

other: humans, guinea pigs

Strain:

not specified

Sex:

male/female

Route:

epicutaneous, semiocclusive

Vehicle:

not specified

Concentration / amount:

0.1% test chemical (approx. 0.1 ml)

Day(s)/duration:

3 times per week for 3 weeks and on Monday of week 4

Adequacy of induction:

not specified

Route:

epicutaneous, occlusive

Vehicle:

not specified

Adequacy of induction:

not specified

Route:

epicutaneous, occlusive

Vehicle:

not specified

Concentration / amount:

10% solution of the test chemical

Adequacy of induction:

not specified

No.:

#1

Route:

epicutaneous, occlusive

Vehicle:

not specified

Concentration / amount:

A cream containing 0.1% test chemical (approx. 0.1 ml)

Day(s)/duration:

48 hours

Adequacy of challenge:

not specified

No.:

#1

Route:

epicutaneous, occlusive

Vehicle:

not specified

Adequacy of challenge:

not specified

No.:

#1

Route:

epicutaneous, occlusive

Vehicle:

not specified

Concentration / amount:

1 or 2% solutions of the test chemical

Adequacy of challenge:

not specified

No. of animals per dose:

1. 101 men and women (18-65 years old
2. no data available
3. no data available

Details on study design:

Weight of evidence approach based on similar chemicals

Challenge controls:

no data available

Positive control substance(s):

not specified

Reading:

1st reading

Group:

test chemical

No. with + reactions:

0

Clinical observations:

no signs of sensitization observed

Remarks on result:

no indication of skin sensitisation

Interpretation of results:

other: not sensitizing

Conclusions:

By applying the weight of evidence approach, the test chemical can be estimated to be not sensitizing to skin. Comparing the annotations with criteria of CLP regulation, the test chemical can be classified under the category "Not Classified".

Executive summary:

The dermal sensitization potential of the test chemical is being estimated based on the experimental data for the various test chemicals.

Patch test was performed to determine the allergenic potential of the test chemical when applied to the skin as a part of the formulation.

A cream containing 0.1% test chemical (approx. 0.1 ml) was applied via a semi-occlusive patch to the back or arm of 101 men and women (18-65 years old).During a 6-week period. During the first 3 weeks of testing, patches were applied on Mondays, Wednesdays, and Fridays and removed 24 h after application.The last induction patches were applied on Monday of week 4 and removed 24 h later. Reactions were scored 48 h after patch removal.

After a rest period of one week, on the Monday of week 6, a challenge patch was placed on each subject (new site) and removed 48 h later. Reactions were scored 48 and 72 h after application.

Reactions were scored after patch removal according to the following scale: 0 (negative), 1 + (erythema), 2 + (erythema and edema or induration), 3 + (erythema, edema/induration and vesiculation), and 4 + (erythema, edema/induration, bulla, with or without ulceration).

No significant reactions were observed during induction or challenge phases. Hence, the test chemical was considered to be not sensitizing to skin when tested as a part of cream formulation.

This is supported by a study conducted on guinea pigs to observe the sensitization potency of test chemical. The test chemical could not elicit any sensitization reactions in treated animals. Hence the test chemical can be considered as non-sensitizing to skin of guinea pigs.

The above results are further supported by a skin sensitization study conducted in guinea pigs to observe the skin sensitization effects of test chemical.

In this study, the test animals were treated dermally with 10% solution of the test chemical during induction. After induction, treated animals were dermally exposed to challenge concentration of 1 or 2% solutions of the test chemical.

Since the test chemical failed to induce any cutaneous reaction at challenge concentrations, the test chemical was considered as not sensitizing to guinea pigs.

By applying the weight of evidence approach, the test chemical can be estimated to be not sensitizing to skin. Comparing the annotations with criteria of CLP regulation, the test chemical can be classified under the category "Not Classified".

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

The dermal sensitization potential of the test chemical is being estimated based on the experimental data for the various test chemicals.

Patch test was performed to determine the allergenic potential of the test chemical when applied to the skin as a part of the formulation.

A cream containing 0.1% test chemical (approx. 0.1 ml) was applied via a semi-occlusive patch to the back or arm of 101 men and women (18-65 years old).During a 6-week period. During the first 3 weeks of testing, patches were applied on Mondays, Wednesdays, and Fridays and removed 24 h after application.The last induction patches were applied on Monday of week 4 and removed 24 h later. Reactions were scored 48 h after patch removal.

After a rest period of one week, on the Monday of week 6, a challenge patch was placed on each subject (new site) and removed 48 h later. Reactions were scored 48 and 72 h after application.

Reactions were scored after patch removal according to the following scale: 0 (negative), 1 + (erythema), 2 + (erythema and edema or induration), 3 + (erythema, edema/induration and vesiculation), and 4 + (erythema, edema/induration, bulla, with or without ulceration).

No significant reactions were observed during induction or challenge phases. Hence, the test chemical was considered to be not sensitizing to skin when tested as a part of cream formulation.

This is supported by a study conducted on guinea pigs to observe the sensitization potency of test chemical. The test chemical could not elicit any sensitization reactions in treated animals. Hence the test chemical can be considered as non-sensitizing to skin of guinea pigs.

The above results are further supported by a skin sensitization study conducted in guinea pigs to observe the skin sensitization effects of test chemical.

In this study, the test animals were treated dermally with 10% solution of the test chemical during induction. After induction, treated animals were dermally exposed to challenge concentration of 1 or 2% solutions of the test chemical.

Since the test chemical failed to induce any cutaneous reaction at challenge concentrations, the test chemical was considered as not sensitizing to guinea pigs.

By applying the weight of evidence approach, the test chemical can be estimated to be not sensitizing to skin. Comparing the annotations with criteria of CLP regulation, the test chemical can be classified under the category "Not Classified".

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

By applying the weight of evidence approach, the test chemical can be estimated to be not sensitizing to skin. Comparing the annotations with criteria of CLP regulation, the test chemical can be classified under the category "Not Classified".