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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report date:
2010

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Sulphamidic acid
EC Number:
226-218-8
EC Name:
Sulphamidic acid
Cas Number:
5329-14-6
Molecular formula:
H3NO3S
IUPAC Name:
sulfamic acid
Test material form:
solid: crystalline
Details on test material:
White crystals
Purity = 99.85%
Impurity: SO4 = 0.02%; H2O = 0.02%; FE = 0.0003%; PB = 0.0003%.

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source:Charles River Deutschland GmbH, D-97633 Sulzfeld.
- Age at study initiation:Approximately 8 weeks (males) and 12 weeks (females) at the time of administration.
- Weight at study initiation: See Table 2.
- Health conditions: A health inspection was performed prior to the commencement of treatment to ensure, that the animals were in a good state of health. Special attention was paid to the skin to be treated, which was intact and free from any abnormality.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): Mean of 22°C +/- 3 °C (continuous control and recording).
- Humidity (%): Mean of 30 – 70 % (continuous control and recording).
- Air changes (per hr): 12 per hour.
- Photoperiod (hrs dark / hrs light):Artificial light from 6 a.m. to 6 p.m.
- Cages:Single caging in Makrolon cages type III (37.5 cm x 21.5 cm bottom area, 18 cm height). Wire mesh lids. Sanitation of cages once a week.
- Bedding material:Aspen wood chips, Fa. ABEDD Dominik Mayr KEG, A-8580 Köflach, autoclaved. Random samples of the bedding material are analysed for contaminants by the supplier. Changes 1 / week.
- Environmental enrichment:Nibbling wood bricks (10 cm x 2 cm x 2 cm) and nesting material, both from the same material and source as the bedding material, were offered to the animals once a week.
- Feed: Ssniff R/M-H maintenance diet for rats and mice (item V1534-300) ad libitum, supplied by Ssniff Spezialdiäten GmbH, 59494 Soest, Germany. Analysis of the feed for ingredients and contaminants is performed randomly by Ssniff.
- Water:Tap water, from an automatic watering system, ad libitum.
Random samples of the water are analysed by the "AGES",
A-1226 Vienna, to check, if the water fulfils the requirements for drinking water for humans.
-Identification:Labelling with felt-tipped pen on the tail and on the cage.
-Acclimatisation: At least 7 days.

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
water
Details on dermal exposure:
"SULPHAMIDIC ACID" was administered once topically on an area of approximately
6.5 cm x 8 cm on the dorsal thoracic region of 5 male and 5 female Sprague Dawley rats.
The dose was 2000 mg per kg body weight.
A cellulose patch with the calculated amount of the test substance on the surface and soaked with deionised water to get optimal contact with the skin, was applied to the test site and held in place by fixing marginally with non irritating tape.
The test site was covered by a semi-occlusive dressing.
The duration of the exposure was 24 hours.
Duration of exposure:
The duration of exposure was 24 hours.
Doses:
2000 mg/kg
No. of animals per sex per dose:
5 per sex per dose
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: yes
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
All animals survived until the scheduled termination of the study.
Clinical signs:
See Table 3.
General findings: All animals did not show any clinical signs during the entire observation period.
Observations of skin condition: Exposed skin was not found to be altered by the test substance.
Body weight:
Body weights were determined
• before administration.
• 7 days p.a.
• 14 days p.a.
Body weight gain was calculated for each week of the study, i.e. between
• 0 and 7 days p.a.
• 7 and 14 days p.a.
Gross pathology:
See Table 4.
No abnormal findings were made in the animals at terminal necropsy.
Other findings:
Sex differences:
No noteworthy sex difference in the response to the test substance was derived from clinical observations or post-mortem findings.

Any other information on results incl. tables

Table1: Synopsis of the results

Sex

Animal

Dose

Number of animals

 

Nos.

(mg / kg b.w.)

exposed

affected

deceased

m

321-325

2000

5

0

0

f

326-330

2000

5

0

0

Table2: Body weights and body weight gain.

Individual data, mean and standard deviation SD.

Dose

Animal

Body weight (g)

Body weight gain (g)

Sex

No.

before
administr.

7 days
p.a.

14 days
p.a.

death

0-7 days
p.a.

7-14 days
p.a.

 

321

293

340

388

-

47

48

2000 mg/kg

322

278

335

378

-

57

43

male

323

289

312

347

-

23

35

 

324

289

328

378

-

39

50

 

325

271

296

331

-

25

35

 

mean

284.0

322.2

364.4

-

38.2

42.2

 

SD

9.2

18.1

24.2

-

14.5

7.0

 

326

242

254

268

-

12

14

2000 mg/kg

327

253

253

261

-

0

8

female

328

229

230

234

-

1

4

 

329

234

241

252

-

7

11

 

330

233

235

246

-

2

11

 

mean

238.2

242.6

252.2

-

4.4

9.6

 

SD

9.5

10.7

13.2

-

5.0

3.8

Table3: Observations in life.

Findings

Dose
(mg / kg), sex

No. of the affected animals

Observation time
(p.a.)
   first      last

Maximum grade of severity

no clinical signs

2000 m

321, 322, 323, 324, 325

0 h / 14 d

-

 

2000 f

326, 327, 328, 329, 330

0 h / 14 d

-

Table4: Necropsy findings.

SYSTEM
Organ, finding

Dose
(mg / kg)
sex

No. of affected
animals

no abnormal findings

2000, m

321, 322, 323, 324, 325

 

2000, f

326, 327, 328, 329, 330

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
No local or systemic test substance related effects were noted from clinical observations or post-mortem examination at a dose of 2000 mg test substance per kg body weight. Therefore, the LD50 (dermal, rat) is >2000 mg/kg bw.
Executive summary:

No local or systemic test substance related effects were noted in this limit test for acute dermal toxicity, applying 2000 mg/kg bw semiocclusively. Clinical observations and post-mortem examination did not reveal any test substance related effects. Therefore, the LD50 (dermal, rat) is >2000 mg/kg bw.