Registration Dossier
Registration Dossier
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EC number: 231-871-7 | CAS number: 7773-06-0
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- 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:
- 1 993
- Report date:
- 1993
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Ammonium sulphamidate
- EC Number:
- 231-871-7
- EC Name:
- Ammonium sulphamidate
- Cas Number:
- 7773-06-0
- Molecular formula:
- H3NO3S.H3N
- IUPAC Name:
- sulfamic acid
Constituent 1
- Specific details on test material used for the study:
- The test substance was Basensol GS, which was composed of 100% ammonium sulphamidate
Test animals
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or test system and environmental conditions:
- 3 young adult rabbits (2.6 to 2.8 kg each) were housed in fully air-conditioned rooms. Central air-conditioning guaranteed a range of 20-24°C for temperature and of 30-70% for relative humidity.
Day/nith rhythm of 12 hours/12 hours. Single housing.
About 250 mL tap water per animal per day and about 130 g diet per animal per day.
Acclimatization for at least one week.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.5 mL of the unchanged liquid test substance (single dose)
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 3 animals (2 males and 1 female)
- Details on study design:
- Weight determination: shortly before application of the test substance.
Application site: upper third of the back or flanks.
Readings: about 1 hour after removal of the patch, 24, 48 and 72 hours after application.
General observations: a check was made twice each workday and once saturdays, sundays and public holidays for general observations and for any dead or moribund animals.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- ca. 0
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the test conditions chosen and considering the described findings, Basensol GS (i.e. ammonium sulphamidate) does not give indication of an irritant property to the skin.
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