N-[3-(diethylamino)phenyl]acetamide

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Justification for type of information:

Data is from safety assesment report

Data source

Reference

Reference Type:

review article or handbook

Title:

IUCLID DATASET

Author:

OECD

Year:

2005

Bibliographic source:

OECD HPV Chemicals Programme, SIDS Dossier, approved at SIAM 15 (22-APR-2005)

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: as mentioned below

Principles of method if other than guideline:

The skin sensitization potential of Trimellitic anhydride (CAS no: 552-30-7) was conducted on ten male Hartley guinea pigs by mean of Modified Buehler Dermal Sensitization method under occlusive condition.

GLP compliance:

not specified

Type of study:

other: Modified Buehler Dermal Sensitization

Justification for non-LLNA method:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

1,3-dioxo-1,3-dihydro-2-benzofuran-5-carboxylic acid

Cas Number:

552-30-7

Molecular formula:

C9H4O5

IUPAC Name:

1,3-dioxo-1,3-dihydro-2-benzofuran-5-carboxylic acid

Test material form:

solid

Details on test material:

- Name of test material (as cited in study report): Trimellitic anhydride (TMA)
- Molecular formula: C9H4O5
- Molecular weight: 192.1256 g/mol
- Substance type: Organic
- Physical state: Solid
-Smiles: c1cc2c(cc1C(=O)O)C(=O)OC2=O
-InChI: 1S/C9H4O5/c10-7(11)4-1-2-5-6(3-4)9(13)14-8(5)12/h1-3H,(H,10,11)

Specific details on test material used for the study:

- Name of test material (as cited in study report): Trimellitic anhydride (TMA)
- Molecular formula: C9H4O5
- Molecular weight: 192.1256 g/mol
- Substance type: Organic
- Physical state: Solid
-Smiles: c1cc2c(cc1C(=O)O)C(=O)OC2=O
-InChI: 1S/C9H4O5/c10-7(11)4-1-2-5-6(3-4)9(13)14-8(5)12/h1-3H,(H,10,11)
- Purity :98%
-Impurities:2%

In vivo test system

Test animals

Species:

guinea pig

Strain:

Hartley

Sex:

male

Details on test animals and environmental conditions:

No data available

Study design: in vivo (non-LLNA)

Induction

Route:

epicutaneous, occlusive

Vehicle:

other: Vehicle used but not detailed information available.

Concentration / amount:

300mg (0.3g)

Day(s)/duration:

3 weeks

Adequacy of induction:

not specified

Challenge

Challenge 1

No.:

#1

Route:

epicutaneous, occlusive

Vehicle:

other: Vehicle used but not detailed information available.

Concentration / amount:

300mg (0.3g)

Day(s)/duration:

13 days

Adequacy of challenge:

not specified

Challenge 2

No.:

#2

Route:

epicutaneous, occlusive

Vehicle:

other: Vehicle used but not detailed information available.

Concentration / amount:

300mg (0.3g)

Day(s)/duration:

48 hours

Adequacy of challenge:

not specified

No. of animals per dose:

20 (ten control and 10 test )

Details on study design:

RANGE FINDING TESTS:

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Exposure period: 6 hours
- Test groups:10
- Control group: no data
- Site: backs of guinea pigs
- Frequency of applications: once per week for three weeks
- Duration: 3 weeks
- Concentrations: 300mg (0.3g)


B. CHALLENGE EXPOSURE
- No. of exposures:1
- Day(s) of challenge: Two weeks following the last induction phase
- Exposure period: 6 hours
- Test groups: 10 guinea pigs
- Control group: 10 guinea pigs
- Site: backs of guinea pigs
- Concentrations: 300mg (0.3g)
- Evaluation (hr after challenge): no data

C. RECHALLENGE EXPOSURE
- No. of exposures:1
- Day(s) of challenge: 13 days later
- Exposure period: 6 hours
- Test groups: 10 guinea pigs
- Control group: 10 guinea pigs
- Site: backs of guinea pigs
- Concentrations: 300mg (0.3g)
- Evaluation (hr after challenge): 24 and 48 hours after patch removal

Challenge controls:

Yes concurrent vehicle. (10 guine pigs )

Study design: in vivo (LLNA)

Statistics:

Bishop, Fineberg, and Holland Discrete Multivariate Analysis, 1975. The use of solvents appeared to increase the dermal sensitization potential of TMA, presumable by increasing uptake.

Results and discussion

In vivo (non-LLNA)

Results

Results 1

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

Dose level:

300mg (0.3g)

No. with + reactions:

0

Total no. in group:

10

Clinical observations:

Positive erythema reactions (score > 2) were not observed in any treated or sham animals following either challenge dose.

Remarks on result:

no indication of skin sensitisation

Results 2

Reading:

2nd reading

Hours after challenge:

48

Group:

test chemical

Dose level:

300mg (0.3g)

No. with + reactions:

0

Total no. in group:

10

Clinical observations:

Positive erythema reactions (score > 2) were not observed in any treated or sham animals following either challenge dose.

Remarks on result:

no indication of skin sensitisation

In vivo (LLNA)

Cellular proliferation data / Observations:

Positive erythema reactions (score > 2) were not observed in any treated or sham animals following either challenge dose.A reaction with a Draize erythema score of 2 or greater in the treated animals was considered a positive response. The amount of test article used during the challenge phase was intended to produce a Draize erythema reaction of 1 or less in control animals.

Any other information on results incl. tables

Number of animals per erythema score
Group	Challenge	Time of scoring
		24 hours					48 hours
		Erythema score					Erythema score
		0	1	2	3	4	0	1	2	3	4
Treated	1	7	3	0	0	0	9	1	0	0	0
Sham	1	10	0	0	0	0	10	0	0	0	0
Treated	2	10	0	0	0	0	10	0	0	0	0
Sham	2	9	1	0	0	0	10	0	0	0	0

Applicant's summary and conclusion

Interpretation of results:

other: Not sensitizing

Conclusions:

Positive erythema reactions (score > 2) were not observed in any treated or sham animals following either challenge dose. Therefore chemical Trimellitic anhydride (CAS no: 552-30-7) was considered to be not sensitizing to the skin ten male Hartley guinea pigs.

Executive summary:

The skin sensitization potential of Trimellitic anhydride (CAS no: 552-30-7) was conducted on ten male Hartley guinea pigs by mean of Modified Buehler Dermal Sensitization method under occlusive condition.

 

 About 300mg (0.3g) of TMA was applied to the backs of 10 guinea pigs once per week for three weeks. Dosing material was held in place using an elastic adhesive bandage. All wrappings were removed 6 hours after each application. Two weeks following the last induction phase animals were challenged at dose of 300mg (0.3g) to the backs of each ten treated and ten control animals. Test article was held in place for 6 hours.

 

A second challenge dose was applied in the same manner 13 days later. Approximately 24 and 48 hours after removal of each challenge patch, the test sites were scored for edema and erythema according to the method of Draize. A reaction with a Draize erythema score of 2 or greater in the treated animals was considered a positive response. The amount of chemical used during the challenge phase was intended to produce a Draize erythema reaction of 1 or less in control animals.

 

Since the Positive erythema reactions (score > 2) were not observed in any treated or sham animals following either challenge dose, the chemical Trimellitic anhydride (CAS no: 552-30-7) was considered to be not sensitizing to the skin ten male Hartley guinea pigs.