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Toxicological information

Acute Toxicity: oral

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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:
1986
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

Constituent 1
Chemical structure
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

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.