Registration Dossier
Registration Dossier
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EC number: 248-765-1 | CAS number: 27987-25-3
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1986
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: 79/831/EWG, Annex V, Part B
- Deviations:
- yes
- Remarks:
- lower number of animals used
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Bis(methylcyclohexyl) phthalate
- EC Number:
- 248-765-1
- EC Name:
- Bis(methylcyclohexyl) phthalate
- Cas Number:
- 27987-25-3
- Molecular formula:
- C22H30O4
- IUPAC Name:
- bis(1-methylcyclohexyl) phthalate
- Test material form:
- liquid: viscous
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Winkelmann, Borchen
- Weight at study initiation: male: 180 g (mean; female: 164 g (mean)
- Age at study initiation: young adult rats
- Fasting period before study: 16 h
- Housing: 2 animals per cage (Makrolon 3)
- Diet (e.g. ad libitum): Altromin-Haltungsdiât 1324, Fa. Altromin GmbH, 4937 Lage (D), ad libitum
- Water (e.g. ad libitum): tap wter (ad libitum)
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): ca. 23°C
- Humidity (%): 50-70%
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: 2% CMC (carboxymethyl cellulose) and 0.5% cremophor
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 2
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:1 d before and on day of application; 48 h, 7 d and 14 days after application
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, histopathology
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred.
- Clinical signs:
- other: Durring the first 3 hours after application all animals showed reduced activity.
- Gross pathology:
- There were no macroscopic pathological findings in the animals sacrificed at the end of the observation period.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of this study the median lethal dose of Edenol 344 after oral administration was found to be greater than 2000 mg/kg bw in rats.
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