Registration Dossier
Registration Dossier
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EC number: 244-343-6 | CAS number: 21351-39-3
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- end on 13-SEP-2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline and GLP study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Uronium hydrogen sulphate
- EC Number:
- 244-343-6
- EC Name:
- Uronium hydrogen sulphate
- Cas Number:
- 21351-39-3
- Molecular formula:
- CH4N2O.H2O4S
- IUPAC Name:
- hydrogen [amino(hydroxy)methylidene]azanium sulfate
- Details on test material:
- - Name of test material (as cited in study report): aduct urea-sulfuric
- Physical state: liquid
- Stability under test conditions: no data
- Storage condition of test material: dry, ventilated well, away from inflammable materials
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland GmbH (Sulzfeld)
- Age at study initiation: no data
- Weight at study initiation: 224 - 268 g
- Fasting period before study: no
- Housing: transparent macrolone cages with two or three in each cage, males and females separated
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 22 +/- 3 °C
- Humidity: 30 - 70%
- Air changes: 10 times / hour
- Photoperiod: 12hrs dark / 12hrs light
IN-LIFE DATES: From June 22th to July 28th 2010
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: back and flank
- % coverage: 6 x 8 cm
- Type of wrap if used: 4-layer gauze pack, fixed with Micropore tape
REMOVAL OF TEST SUBSTANCE
- Washing: yes
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw (ca. 1.3 ml/kg bw)
- Concentration: undiluted - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5 males and 5 females
- Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
> observations: each rat was observed 1, 3 and 6 hours after the start of the application and thereafter once daily
> Body weight: on days 0, 7 and 14
- Necropsy of survivors performed: yes - Statistics:
- not applicable
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: no mortality observed
- Mortality:
- Neither female nor male rats died on account of the treatment or showed severe sign of toxicosis.
- Clinical signs:
- other: All animals showed piloerection on day 0 after 1 hours and normal behaviour after 3 hours as well as 6 hours. From day 1 to the end of the observation period on day 14 no abnormalities were revealed.
- Gross pathology:
- The post mortem inspection revealed no pathological abnormalities.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Dermal LD50 > 2000 mg/kg bw in rats
- Executive summary:
In an acute dermal toxicity study (OECD 402, GLP), a group of Wistar rats (5/sex) was dermally exposed to undiluted uronium hydrogen sulphate for 24 hours at the dose of 2000 mg/kg bw. Animals then were observed for 14 days.
Dermal LD50 (Males/Females) > 2000 mg/kg bw (no mortality observed)
No effects were observed on mortality, body weight gain and gross pathology.
No clinical signs were observed, except at 1 hour after application (piloerection in all animals).
Based on this study, uronium hydrogen sulphate is of low toxicity and is not classified as dangerous for acute dermal toxicity according to EU criteria (DSD or CLP).
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