Registration Dossier
Registration Dossier
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EC number: 811-285-3 | CAS number: 1637294-12-2
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- February 2015 to April 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 420 (Acute Oral Toxicity - Fixed Dose Method)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- 3-[2-methyl-4-(2-methylpropyl)phenyl]propanal
- EC Number:
- 811-285-3
- Cas Number:
- 1637294-12-2
- Molecular formula:
- C14H20O
- IUPAC Name:
- 3-[2-methyl-4-(2-methylpropyl)phenyl]propanal
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- Name (as stated in the report): GR-88-0778
Lot No: Batch 6
Aspect: Colourless liquid
Expiration date: March 29, 2017
Test animals
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- Crl:WI (outbred, SPF-Quality)
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- - Source: Charles River Deutschland, Sulzfeld, Germany
- Number of animals: Pilot Study: 1 female, Main Study: 4 females (females were nulliparous and non-pregnant).
- Age and body weight: Young adult animals (approx. 8-9 weeks old) were selected. Body weight variation did not exceed +/- 20% of the sex mean.
- Identification: Earmark
- Health inspection: 4At least prior to dosing. It is ensured that the animals were healthy and without any abnormality that might affect the study integrity
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- - Method: Oral gavage, using plastic feeding tubes. The test substance was stirred on a magnetic stirrer during dosing.
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- a group of 4 females (females were nulliparous and non-pregnant) / 1 dose per group
- Control animals:
- no
- Details on study design:
- Initially, GR-88-0778 was administered by oral gavage to one female Wistar rat at 2000 mg/kg body weight. As no mortality occurred and no signs of significant toxicity were observed, the main study was conducted with a fixed dose of 2000 mg/kg body weight administered to four female rats. The animals were subjected to daily observations. Body weights were determined on Days 1, 8 and 15.
Macroscopic examination was performed after terminal sacrifice.
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 occurred.
- Clinical signs:
- other: Hunched posture, uncoordinated movements and/or piloerection were noted for the animals on Day 1.
- Gross pathology:
- No abnormalities were found at macroscopic post mortem examination of the animals
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Conclusions:
- The minimum oral lethal dose of GR-88-0778 in rats was established to exceed 2000 mg/kg body weight.
- Executive summary:
The acute oral toxicity with GR-88-0778 was assessed in the rat (Fixed Dose Method) according to the OECD No.420 (2001) " Acute toxicity-oral, Fixed Dose Procedure".
Initially, GR-88-0778 was administered by oral gavage to one female Wistar rat at 2000 mg/kg body weight. As no mortality occurred and no signs of significant toxicity were observed, the main study was conducted with a fixed dose of 2000 mg/kg body weight administered to four female rats. The animals were subjected to daily observations. Body weights were determined on Days 1, 8 and 15. Macroscopic examination was performed after terminal sacrifice.
No mortality occurred.
Hunched posture, uncoordinated movements and/or piloerection were noted for the animals on Day 1.
The body weight gain shown by the animals over the study period was considered to be normal.
No abnormalities were found at macroscopic post mortem examination of the animals.
The minimum oral lethal dose of GR-88-0778 in rats was established to exceed 2000 mg/kg body weight.
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