Registration Dossier
Registration Dossier
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EC number: 241-629-2 | CAS number: 17647-86-8
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2015-02-23 to 2015-2015-03-10
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP and guideline compliant study report.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- (1987)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Version / remarks:
- (2008)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1200 (Acute Dermal Toxicity)
- Version / remarks:
- (1998)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Bioassay Labor für biologische Analytik GmbH, Im Neuenheimer Feld 515-519, 69120 Heidelberg, Germany
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Potassium N,N-dimethylglycinate
- EC Number:
- 241-629-2
- EC Name:
- Potassium N,N-dimethylglycinate
- Cas Number:
- 17647-86-8
- Molecular formula:
- C4H8NO2.K
- IUPAC Name:
- potassium 2-(dimethylamino)acetate
- Details on test material:
- - Name of test material (as cited in study report): Potassium N,N-dimethylglycinate
- Substance type: organic salt
- Physical state: solid
- Analytical purity: 94.2 g/100 g
- Expiration date of the lot/batch: September 04, 2016
- Storage condition of test material: room temperature
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: Young adult animals (male animals approx. 8 weeks, female animals approx. 12 weeks)
- Weight at study initiation: males: 220.8 ± 6.9 g; females: 204.2 ± 7.3 g
- Housing: Single housing in Makrolon cage, type III
- Diet: ad libitum (VRF1(P); SDS Special Diets Services, 67122 Altrip, Germany)
- Water: ad libitum (tap water)
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30 - 70
- Air changes (per hr): approx. 10
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- water
- Remarks:
- deionized
- Details on dermal exposure:
- TEST SITE
- Area of exposure: Dorsal and dorsolateral parts of the trunk
- coverage: About 40 cm² (corresponds to at least 10% of the body surface)
- Type of wrap if used: air-permeable dressing (4 layers of absorbent gauze (Ph. Eur. supplied by Lohmann GmbH & Co., KG) and stretch bandage (Fixomull® Stretch (adhesive fleece) supplied by Beiersdorf AG)
REMOVAL OF TEST SUBSTANCE
- Washing: Rinsing of the application site with warm water
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount applied: 2.88 mL/kg bw
- Concentration (if solution): 80 g/100 mL - Duration of exposure:
- 24 hours
- Doses:
- 2300 mg/kg bw corresponding to an actual dose of 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
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight - Statistics:
- Not performed.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality was observed throughout the study period.
- Clinical signs:
- other: No systemic clinical signs were observed in both male and female animals. The following local effects were observed in male and female animals: Males: Well-defined erythema (grade 2) was noted in all male animals from study day 1 until study day 3, which
- Gross pathology:
- No macroscopic pathologic abnormalities were noted in all animals (5 males and 5 females) examined on the last day of observation.
Applicant's summary and conclusion
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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