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EC number: 815-500-1 | CAS number: 1853175-99-1
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 22/07/2015-06/08/2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
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 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- 1,3-dioxane, 2-(3,3-dimethyl-1-cyclohexen-1-yl)-2,5,5-trimethyl
- Cas Number:
- 1853175-99-1
- Molecular formula:
- C15H26O2
- IUPAC Name:
- 1,3-dioxane, 2-(3,3-dimethyl-1-cyclohexen-1-yl)-2,5,5-trimethyl
Constituent 1
- Specific details on test material used for the study:
- Identification: Maderal ZA1076, code number: PH15/0488
Date of received: 08/07/2015
Container: glass flask (x1)
Quantity: 118.10 g (container + content)
Batch: 100026324
Production date: 11/03/2015
Form: liquide
Colour: colourless
Storage: room temperature / darkness
Expiry date: 10/03/2016
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Remarks:
- SPF Caw
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Animals:
Source: Elevage JANVIER LABS
Acclimatation: at least 5 days
Age at the beginning of the study: 8 weeks
Identified prior to inclusion by numbered rings on the edge of one ear
Housing:
By group of three female in solid-bottomed clear polycarbonates cages with a stainless steel mesh lid.
Bedding: Sawdust changed at least 2 times a week.
Air: Conventional air conditioned animal husbandry
T°: 19-25°C
Relative Humidity: 30-70%
Rate of air exchange: 10 changes per hour
Photoperiod: 12h light (07.00-19.00) /12h darkness
Food and drink:
Drinking water: tap-water from public distribution system, analysed (chemical and microbiological) every 6 months by Eurofins IPL - Atlanique (Bordeaux)
Foodstuff: A04, supplied by SAFE
Both were supplied freely
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- Gavage under a volume of 2.11 mL/kg (~2 g/kg), using a suitable syringe graduated fitted with an oesophageal metal canula
- Doses:
- 2000 mg/kg body weight of the test item
- No. of animals per sex per dose:
- 6
- Control animals:
- yes
- Remarks:
- 3 female rats, received the control item distrilled water by gavage under a volume of 10 mL/kg body weight using a suitable syringe fitted with an oesophageal metal canula
- Details on study design:
- Daily examination: identify behavioural / toxic effect on the major physiological functions during 14 days following the administration of the test item
Weight examination: On D0 (before administering the test item) ; D2 ; D7 ; D14
End of the test examination: On D14, animals were anaesthetised with sodium pentobarbital and administration continued to fatal levels. Macroscopic observations were noted. Only organs likely to be modified in case of acute toxicity were examined. No organ was removed and preserved in view to microscopic examination - Statistics:
- Not specified
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occured during the study
- Clinical signs:
- No clinical signs related to the administration of the test item were observed
- Body weight:
- The body weight evolution of the animals remained normal during the study
- Gross pathology:
- Macroscopic examnation at the end of the study did not reveal treatment related changes
Any other information on results incl. tables
Deviations:
Relative humidity > 70% was registered on 05/08/2015. Maximum value recorded : 71%
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Executive summary:
The acute oral toxicity was performed according to the OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
The results are the following:
LD50 > 2000 mg/kg body weight by oral route in the rat
LD50 cut-off of the test item may be considered > 5000 mg/kg body weight by oral route in the rat
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