Registration Dossier
Registration Dossier
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EC number: 241-158-2 | CAS number: 17091-31-5
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 01/2008 to 03/2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- Bromo(hexahydro-2H-azepin-2-onato-N)magnesium
- EC Number:
- 241-158-2
- EC Name:
- Bromo(hexahydro-2H-azepin-2-onato-N)magnesium
- Cas Number:
- 17091-31-5
- Molecular formula:
- C6H10BrMgNO
- IUPAC Name:
- magnesium(2+) ion 2-oxoazepan-1-ide bromide
- Reference substance name:
- ε-caprolactam
- EC Number:
- 203-313-2
- EC Name:
- ε-caprolactam
- Cas Number:
- 105-60-2
- Molecular formula:
- C6H11NO
- IUPAC Name:
- azepan-2-one
- Test material form:
- solid: particulate/powder
Constituent 1
additive 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 07072601
- Expiration date of the lot/batch: 26.07.2008
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Elevage JANVIER (53940 Le Genest St Isle - France)
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 8 weeks
- Weight at study initiation: 189 to 209 g
- Fasting period before study: yes
- Housing: solid-bottomed clear polycarbonate cages with a stainless steel mesh lid
- Water (e.g. ad libitum): tap-water from public distribution system
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 to 22
- Humidity (%): 36 to 57
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Amount of vehicle (if gavage): 10 mL/kg body weight
MAXIMUM DOSE VOLUME APPLIED: 2000 mg/kg body weight
- Doses:
- 2000 mg/kg body weight
- No. of animals per sex per dose:
- 3
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: D2, D7, and D14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, organ weights, histopathology
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- not observed
- Clinical signs:
- It was registered in the treated animals, from thirty minutes after the test item administration, a decrease of the spontaneous activity (6/6) associated with a decrease of the righting reflex (4/6) and a piloerection (6/6). 48 hours after the test item administration, no clinical signs related to the test item administration were noted.
- Body weight:
- It was noted an absence of the body weight gain in the treated animals, 48 hours after the test item administration. Then the body weight evolution of the animals remained normal throughout the study.
- Gross pathology:
- The macroscopical examination of the animals at the end of the study did not reveal treatment-related changes.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The LD50 of the test item Bromo(hexahydro-2H-azepin-2-onato-N)magnesium is higher than 2000 mg/kg body weight by oral route in the rat, in accordance with the OECD guideline n°423.
A classification according to (EU) No. 1272/2008 is not required based on this data. - Executive summary:
The LD50 of the test item Bromo(hexahydro-2H-azepin-2-onato-N)magnesium is higher than 2000 mg/kg body weight by oral route in the rat, in accordance with the OECD guideline n°423.
A classification according to (EU) No. 1272/2008 is not required based on this data.
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