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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
26/11/09-05/12/09
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2014
Report date:
2014

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

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:
not specified

Test animals

Species:
rabbit
Strain:
Himalayan
Details on test animals or test system and environmental conditions:
ANIMALS
Species / Strain Rabbit / : Himalayan
Breeder : LPT Laboratory of Pharmacology and Toxicology GmbH & Co. KG, branch Löhndorf, 24601 Löhndorf/Post Wankendorf, Germany
Sex : Male animals
Number of animals : 3
Age (at dosing) : Approx. 7 - 9 months
Body weight
At dosing
Animal no. 1 : 2.6 kg
Animal no. 2 : 2.6 kg
Animal no. 3 : 2.6 kg
Termination of test
Animal no. 1 : 2.6 kg
Animal no. 2 : 2.7 kg
Animal no. 3 : 2.6 kg
Identification of animals : By tattooed number assigned by the Löhndorf breeding station.
Duration of study : At least 20 adaptation days, 1 test day and a follow-up period of 72 hours.

DIET
Commercial diet, ssniff® K-H V2333 (ssniff Spezialdiäten GmbH, 59494 Soest, Germany, The food was available ad libitum before and after the exposure period.
At regular intervals (at least twice a year), the food is analysed1 for contaminants by LUFA-ITL2.

DRINKING WATER
Drinking water was offered ad libitum before and after the exposure period. Samples of the drinking water are examined according to the 'Deutsche Trinkwasserverordnung 2001' [German Regulations on drinking water 2001] by the Wasserbeschaffungsverband Harburg, 21220 Seevetal, Germany, twice a year. In addition, drinking water samples taken at LPT are analysed by LUFA-ITL once a year for means of bacteriological investigations according to the 'Deutsche Trinkwas-serverordnung 2001, Anlage 1' [German Regulations on drinking water 2001, Addendum 1].


HOUSING
Before and after the 4-hour exposure period, the animals were kept singly in cages measuring 380 mm x 425 mm x 600 mm (manufacturer: Dipl. Ing. W. EHRET GmbH, 16352 Schönwalde, Germany) at a room temperature of 20°C ± 3°C (maximum range) and relative humidity of 30% - 70% (maximum range). Deviations from the maximum range caused for example during cleaning procedures are dealt with in SOPs. During the exposure period, the animals were kept singly in restrainers which allowed free movement of the head but prevented a complete body turn. The cages excluded irritation of the skin by excrements and urine. The rooms were lit (150 lux at approx. 1.5 m room height) and darkened on a 12-hour light/12-hour dark cycle.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
not required
Amount / concentration applied:
500 mg/patch and animal
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
3
Details on study design:
DOSE LEVEL AND ADMINISTRATION

Route of administration : Dermal application onto the shaved, intact dorsal skin.
Selection of route of administration : According to OECD guideline and most likely route of exposure.
Dose level : 500 mg/patch and animal (500 mg of the test item were mixed with 0.5 mL aqua ad iniectabilia3, 1000 mg of this paste were applied per animal (≈ 500 mg test item/animal))

Approximately 24 hours before the test, the fur was removed by closely clipping the dorsal area of the trunk of the animals. Care was taken to avoid abrading the skin.

Only animals with healthy intact skin were used.

A dose of 500 mg of the test item was applied to the test site (area: approx. 6 cm2).

The test item was applied to the test site and then covered with a gauze patch. The patch was held in contact with the skin with non-irritating tape for the duration of the exposure period. The surrounding untreated skin served as a control.

Exposure time was 4 hours. During the exposure the animals were kept in comfortable restrainers.

At the end of the exposure time no residual test item had to be removed.

Suspected corrosive / irritating test items:

Initial test
As there was no evidence that the test item will produce severe irritancy or corrosion, a single patch was applied to one animal for 4 hours.

Confirmatory test
As no corrosive or severe irritant effects were observed in the initial test, 2 further animals were employed 24 hours after start of the initial test.

Results and discussion

In vivo

Results
Irritation parameter:
erythema score
Basis:
mean
Time point:
48 h
Score:
0
Max. score:
1
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
3 rabbits were exposed for 4 hours to 500 mg Sulfamic Acid (100%)/patch (semi-occlusive conditions) showed following effects:

An erythema (grade 1) was observed in all animals 60 minutes after patch removal, in animal no. 2 until 24 hours after patch removal.

An oedema (grade 1) was observed in animal no. two 60 minutes after patch removal.

No systemic intolerance reactions.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
In a GLP guideline study conducted according to EC method B.4. and OECD guideline 404, sulfamic acid demonstrated only slight, transient effects on the skin of rabbits which were fully reversible after 48 hours. According to the criteria laid down in the Globally Harmonized System of Classification and Labelling of Chemicals, sulfamic acid is not considered to be irritating to skin.