Registration Dossier
Registration Dossier
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EC number: 249-655-6 | CAS number: 29463-06-7
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2014-04-29 to 2014-05-21
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP and guideline compliant study.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1200 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Japan MAFF 8147
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Tris(2-hydroxyethyl)methylammonium methyl sulphate
- EC Number:
- 249-655-6
- EC Name:
- Tris(2-hydroxyethyl)methylammonium methyl sulphate
- Cas Number:
- 29463-06-7
- Molecular formula:
- C7H18NO3.CH3O4S
- IUPAC Name:
- 1,5-dihydroxy-3-(2-hydroxyethyl)pentan-3-aminium methyl sulfate
- Details on test material:
- - Name of test material (as cited in study report): Tris(2-hydroxyethyl)methylammonium methyl sulphate- Substance type: organic- Physical state: yellowish liquid- Expiration date of the lot/batch: July 2015- Storage condition of test material: Room temperature; avoid temperatures < 5 °C and > 30 °C- Analytical purity: 98.9 %- Lot/batch No.: Lot. 29734916K0
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 Wiga GmbH, Germany- Age at study initiation: males approx. 8 weeks old, females approx. 12 weeks old- Weight at study initiation: 235 g (mean, males); 207.4 g (mean, females)- Fasting period before study: no- Housing: individually in Makrolon cage, type III- Diet: ad libitum (H 15005-29; Ssniff, Spezialitaeten GmbH (Experimental Animal Diets Inc., 59494 Soest, Germany)- Water: ad libitum (tap water)- Acclimation period: at 5 daysENVIRONMENTAL CONDITIONS- Temperature (°C): 22 ± 3- Humidity (%): 30-70- Air changes (per hr): 10- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE- Area of exposure: dorsal and dorsolateral parts of the trunk- % coverage: at least 10 % of the body surface- Type of wrap if used: Stretch bandageREMOVAL OF TEST SUBSTANCE- Washing (if done): with warm water- Time after start of exposure: 24 hoursTEST MATERIAL- Amount(s) applied: 1.47 mL/kg bw- Concentration: undiluted- Constant volume or concentration used: no
- Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days- Frequency of observations and weighing: daily, weighing was performed weekly- Necropsy of survivors performed: yes- Other examinations performed: clinical signs, body weight
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- discriminating dose
- Effect level:
- 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurre during the study.
- Clinical signs:
- other: No systemic clinical signs were observed during clinical examination in male and female animals. All male animals revealed very slight erythema (grade 1) on study day 1. In four female animals very slight erythema (grade 1) was noted on study day 1, while
- Gross pathology:
- No macroscopic pathologic abnormalities were noted in the animals examined on the last day of observation.
Applicant's summary and conclusion
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information
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