Sodium 3-nitrobenzenesulphonate

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Justification for type of information:

Data is from experimental study report

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1991

Report date:

1991

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EU Method B.6 (Skin Sensitisation)

Principles of method if other than guideline:

A maximization test was carried out in female Dunkin-Hartley guinea pigs to assess the skin sensitization potential of test chemical according to EU Method B.6 (Skin Sensitisation).

GLP compliance:

yes

Type of study:

guinea pig maximisation test

Justification for non-LLNA method:

Not specified

Test material

Test material information

Constituent 1

Reference substance name:

Sodium 3-nitrobenzenesulphonate

EC Number:

204-857-3

EC Name:

Sodium 3-nitrobenzenesulphonate

Cas Number:

127-68-4

Molecular formula:

C6H5NO5S.Na

IUPAC Name:

sodium 3-nitrobenzenesulphonate

Test material form:

solid

Details on test material:

Name of the test chemical: Sodium 3-nitrobenzenesulfonate
Molecular Formula:C6H5NO5S.Na
Molecular Weight: 225.1556 g/mol
Substance Type: Organic
Physical State: Solid

In vivo test system

Test animals

Species:

guinea pig

Strain:

Dunkin-Hartley

Sex:

female

Details on test animals and environmental conditions:

Body weight at the beginning of the study : 275 - 310 g
Acclimatization period: At least 7 days before the beginning of the study in the laboratory for dermal toxicity.
The animals were housed in fully air-conditioned rooms in which a central air-conditioning system ensured a temperature in the range of 20 - 24°C and a relative humidity in the range of 30 - 70%.
The illumination period was 12 h dark and 12 h light.
Type of cage: Makrolon, type IV
No . of animals per cage: 5
Identification of the animals: Ear tag numbering
Type of diet: Kliba 341.4 mm
Water was available ad libitum (tap water; about 2 g of ascorbic acid per 10 l water was added to the drinking water twice a week)

Study design: in vivo (non-LLNA)

Induction

Route:

intradermal and epicutaneous

Vehicle:

water

Concentration / amount:

1st application: Induction 5 % intracutaneous;
2nd application: Induction 50 % occlusive epicutaneous

Day(s)/duration:

96 hours

Adequacy of induction:

highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically

Challenge

Challenge 1

No.:

#1

Route:

epicutaneous, occlusive

Vehicle:

water

Concentration / amount:

25% in aqua bidest.

Day(s)/duration:

24 hours

Adequacy of challenge:

highest non-irritant concentration

Challenge 2

No.:

#2

Route:

epicutaneous, occlusive

Vehicle:

water

Concentration / amount:

25% in aqua bidest.

Day(s)/duration:

24 hours

Adequacy of challenge:

highest non-irritant concentration

No. of animals per dose:

control: 5
test group: 10

Details on study design:

For detecting a possible influence on irritating effects of previous intradermal treatment with Freund's adjuvant, animals pretreated with Freund's adjuvant / 0.9% aqueous NaCl-solution (1 : 1) each, in the same manner as intradermal induction about 3 weeks prior to the application of the test substance were used.
In the preliminary test after two 24-hour percutaneous occlusive applications within 96 hours the minimum irritant concentration was found to be a 50% test substance preparation in aqua bidest. and the maximum non-irritant concentration a 25% test substance preparation in aqua bidest. (48 hours after the beginning of application).
Applicability: It was possible to inject a 5% test substance preparation in 0.9% aqueous NaCl-solution resp. in Freund's adjuvant / 0.9% aqueous NaCl-solution (1 : 1) with a syringe.

Positive control substance(s):

yes

Remarks:

(1-chlor-2.4-dinitro-benzol)

Results and discussion

In vivo (non-LLNA)

Results

Results 1

Reading:

other: 1st percutaneous challenge

Hours after challenge:

24

Group:

test chemical

Dose level:

25%

No. with + reactions:

2

Total no. in group:

10

Clinical observations:

moderate to severe erythema and very slight edema; well-defined erythema could be observed in 2 out of 10 animals.

Remarks on result:

positive indication of skin sensitisation

Results 2

Reading:

other: 2nd challenge

Hours after challenge:

24

Group:

test chemical

Dose level:

25%

No. with + reactions:

2

Total no. in group:

10

Clinical observations:

moderate to severe erythema and very slight edema; well-defined erythema (1 animal with very slight erythema.

Remarks on result:

positive indication of skin sensitisation

In vivo (LLNA)

Cellular proliferation data / Observations:

moderate to severe erythema and very slight edema; well-defined erythema could be observed in 2 out of 10 animals.

Applicant's summary and conclusion

Interpretation of results:

other: sensitising

Conclusions:

The number of animals sensitized is primarily taken into account in the evaluation. The control animals are used to rule out any substance-induced primary skin irritation.
The findings obtained 24 hours after the removal of the patch are taken into account for the determination of the sensitization rate.
The evaluation "sensitizing" results if at least 30 per cent of the animals exhibit skin reactions in this adjuvant test.
Under the test conditions chosen and following the described results, the test chemical has a sensitizing effect on the skin of the guinea pig.

Executive summary:

A maximization test was carried out in female Dunkin-Hartley guinea pigs to assess the skin sensitization potential of test chemical according to EU Method B.6 (Skin Sensitization). In the preliminary test after 24-hour percutaneous occlusive applications within 96 hours, the minimum irritant concentration was observed to be a 50% of test substance preparation in water and the maximum non-irritant concentration was 25% test substance preparation in water (48 hours after the beginning of application).The test was conducted on 10 guinea pigs in test group and 5 guinea pigs in control group. During the induction, the animals were treated intracutaneously at concentration of 5 % and dermally at concentration 50 % under occlusive condition. Later, challenge and rechallenge was performed at a dose of 25% of test chemical in water under occlusive condition and skin reactions were observed. Also 1-chlor-2.4-dinitro-benzol was used as positive control. The findings revealed, moderate to severe erythema, very slight edema and well-defined erythema in 2 out of 10 animals. Thus under the test conditions chosen and the described results, the test chemical was considered as sensitizing to the skin of the guinea pig.