Sulphuric diamide

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2015

Report date:

2015

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)

GLP compliance:

yes (incl. QA statement)

Type of study:

mouse local lymph node assay (LLNA)

Test material

Test material information

Constituent 1

Reference substance name:

Sulphuric diamide

EC Number:

232-262-9

EC Name:

Sulphuric diamide

Cas Number:

7803-58-9

Molecular formula:

H4N2O2S

IUPAC Name:

Sulphuric diamide

Test material form:

solid: crystalline

Specific details on test material used for the study:

Supplier: Changzou Foreign Trade Corp.Batch No.: 0073A15 (A01141026)Physical state: solid, crystalline substanceColour: whiteOdour: pungentStorage in a dry place, protected from light

In vivo test system

Test animals

Species:

mouse

Strain:

CBA/Ca

Sex:

female

Details on test animals and environmental conditions:

Species and strain: CBA/Ca Ola Hsd miceSource: TOXI-COOP ZRT.Hygienic level during the study: Good conventionalNumber of animals: 28 animals/main test (4 animals/treatment group)Sex: Female, nulliparous, non-pregnantAge of animals: Young adult mice; 11-12 weeks old (at start of the main test)Body weight range at starting: 18.1-23.4 g The weight variation in animals involved in the study did not exceed ± 20 % of the mean weight.Acclimatization time: 7 daysAnimal health: Only healthy animals were usedHousing during acclimatization period: Grouped caging in small groupsHousing during the test: Grouped caging (4 animals/cage)Cage type: Type II. Polypropylene / polycarbonateLight: 12 hours daily, from 6.00 a.m. to 6.00 p.m.Temperature: 22 ± 3 °CRelative humidity: 30 – 70 %Housing/Enrichment: Mice were group-housed to allow social interaction, and with deep wood sawdust bedding, to allow digging and other normal rodent activities.

Study design: in vivo (LLNA)

Vehicle:

dimethylformamide

Concentration:

Based on the preliminary test results the test item was examined in the main test at 50 %, 25 %, 10 % and 5 % (w/v) concentrations as formulations in the selected vehicle of N,N-Dimethylformamide (DMF).

No. of animals per dose:

4 animals/group

Details on study design:

Each mouse was topically treated with 25 μL of the appropriate formulations of the test item, the positive control substance or the vehicles (see Table 3) using a pipette, on the dorsal surface of each ear. After the treatments animals were returned to their cages. Each animal was dosed once a day for three consecutive days (Days 1, 2 and 3). There was no treatment on Days 4, 5 and 6.

Positive control substance(s):

hexyl cinnamic aldehyde (CAS No 101-86-0)

Results and discussion

Positive control results:

The positive control group animals were treated with 25% (w/v) HCA solution (dissolved in AOO) concurrent to the test item groups. No mortality, cutaneous reactions or signs of toxicity were observed in the positive control group.Significant lymphoproliferative response (SI ≥ 3) was noted for HCA (SI = 6.9). The results of the positive control item demonstrated appropriate performance of the test in accordance with the relevant guidelines and confirmed validity of the assay.

In vivo (LLNA)

Results

Results 1

Parameter:

SI

Value:

0.8

Test group / Remarks:

sulfamide 50 % in DMF

Results 2

Parameter:

SI

Value:

0.4

Test group / Remarks:

sulfamide 25 % in DMF

Results 3

Parameter:

SI

Value:

0.2

Test group / Remarks:

sulfamide 10 % in DMF

Results 4

Parameter:

SI

Value:

1.1

Test group / Remarks:

sulfamide 5 % in DMF

Cellular proliferation data / Observations:

Based on results of the preliminary irritation/toxicity test where no significant systemic toxicity and/or irritation were observed SULFAMIDE (CAS No. 7803-58-9) was tested in the LLNA at concentrations of 50 %, 25 %, 10 % and 5 % (w/v) as formulations in DMF. Since the test was valid and no sign of systemic toxicity or significant irritation was observed at the applied concentrations, the proliferation values obtained are considered to reflect the real potential of the test item to cause/not cause lymphoproliferation in the Local Lymph Node Assay. According to evaluation criteria of the relevant guidelines, the lack of a significantly (SI ≥ 3) increased lymphoproliferation up to the maximum attainable concentration of 50 % (w/v, based on solubility) and the lack of a significant dose-response relationship are considered evidence that SULFAMIDE (CAS No. 7803-58-9) is not a skin sensitizer.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

In conclusion, under the conditions of the present Local Lymph Node Assay, SULFAMIDE (CAS No. 7803-58-9) tested at the maximum attainable concentration of 50 % (based on solubility) and at concentrations of 25 %, 10 % and 5 % (w/v) as formulations in an appropriate vehicle (DMF) was shown to have no skin sensitization potential.