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Description of key information

LD50 (oral): >2000 mg/kg bw

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
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
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
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

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
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.
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.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
Value:
2 000 mg/kg bw

Additional information

Acute oral

The acute oral toxicity of bis(methylcyclohexyl)phthalate was determined in young Wistar rats. 2000mg/kg of the test substance were administered by gavage in 2 % carboxymethylcellulose and 0.5 % crermphor to 2 male and 2 female rats. Except for a transient reduction in activity immediately after the application for up to 3h, no clinical signs, no effect on body weight, and no alterations during gross pathology were observed. The LD50 was > 2000 mg/kg bw.

Justification for classification or non-classification

Based on the results, the test item is no subject to classification and labelling according to Regulation (EC) No 1272/2008 (CLP).