Sulphamidic acid

Acute Toxicity: dermal

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

Test material information

Constituent 1

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:

other: 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.

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.