N,N-dimethyl-p-toluidine

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Justification for type of information:

data is from peer reviewed journals

Data source

Reference

Reference Type:

publication

Title:

Allergy to the test chemical in dental materials

Author:

Verschueren et.al

Year:

1991

Bibliographic source:

Contact Dermatitis, 1991

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Patch test

Principles of method if other than guideline:

Patch test was performed to evaluate the sensitization potential of the test chemical when used in dental materials

GLP compliance:

not specified

Type of study:

patch test

Justification for non-LLNA method:

No data available

Test material

Test material information

Constituent 1

Reference substance name:

N,N-dimethyl-p-toluidine

EC Number:

202-805-4

EC Name:

N,N-dimethyl-p-toluidine

Cas Number:

99-97-8

Molecular formula:

C9H13N

IUPAC Name:

N,N,4-trimethylaniline

Test material form:

liquid

Details on test material:

- Name of test material: Benzenamine, N,N,N-trimethyl-
- Common Name: N,N-Dimethyl-p-toluidine
- Molecular formula: C9H13N
- Molecular weight: 135.209 g/mol
- Smiles notation: c1(N(C)C)ccc(C)cc1
- InChl: 1S/C9H13N/c1-8-4-6-9(7-5-8)10(2)3/h4-7H,1-3H3
- Substance type: Organic
- Physical state: liquid
- Purity: Greater than 99%.

In vivo test system

Test animals

Species:

other: humans

Strain:

not specified

Sex:

female

Details on test animals and environmental conditions:

Source: Department of Dermatology, Free University Academic Hospital, Amsterdam.
Age: 79 years old

Study design: in vivo (non-LLNA)

Induction

Route:

epicutaneous, occlusive

Vehicle:

petrolatum

Concentration / amount:

5% in petrolatum

Adequacy of induction:

not specified

Challenge

No.:

#1

Route:

epicutaneous, occlusive

Vehicle:

petrolatum

Concentration / amount:

5% in petrolatum

Adequacy of challenge:

not specified

No. of animals per dose:

1

Details on study design:

Patch test with European standard series including scrapings of the patients dentures and a dental material series were conducted. The reactions were observed and scored on day 2,3 after patch removal.

Positive control substance(s):

not specified

Results and discussion

In vivo (non-LLNA)

Results

Key result

Reading:

1st reading

Hours after challenge:

48

Group:

test chemical

Dose level:

5% in petrolatum

No. with + reactions:

1

Total no. in group:

1

Clinical observations:

The patient showed 2+ reaction on day 2,3 to 5% test chemical in petrolatum

Remarks on result:

positive indication of skin sensitisation

Applicant's summary and conclusion

Interpretation of results:

Category 1 (skin sensitising) based on GHS criteria

Conclusions:

The patient showed 2+ reaction on day 2,3 to 5% test chemical in petrolatum. Hence, the test chemical can be considered to be sensitizing to skin.

Executive summary:

Patch test was performed to evaluate the sensitization potential of the test chemical when used in dental materials. A 79 year old female experienced severew burning of her tongue and soreness for more than a year, starting from few months she started wearing her new dentures.Patch test was performed with European standard series including scrapings of the patients dentures and a dental material series to ascertain the causative agent. The reactions were observed and scored on day 2,3 after patch removal.The patient showed 2+ reaction on day 2,3 to 5% test chemical in petrolatum. Hence, the test chemical can be considered to be sensitizing to skin.