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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Study period:
19 Nov - 02 Dec 1996
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP - guideline study

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1996

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
The temperature should be 22 ± 3 °C. Nevertheless, the temperature was 24.0 - 25.5 °C.
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Ditridecyl phthalate
- Physical state: colorless clear liquid
- Analytical purity: 93.7 - 100%
- Lot/batch No.: 2700
- Storage condition of test material: At room temperature

Test animals

Species:
rat
Strain:
Crj: CD(SD)
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Laboratories Japan, Inc., Yokohama, Japan
- Age at study initiation: 6 weeks
- Weight at study initiation: male: 125.8 g (121.4 -129.6 g); female: 114.1 g (109.1 - 118.2 g)
- Fasting period before study: 18 hours before study
- Housing: stainless steel cage
- Diet (ad libitum): CRF-1 from Oriental Yeast Co., Ltd.
- Water (ad libitum): tap water
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 24 - 25.5 °C
- Humidity (%): 51 - 64
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
VEHICLE
- Lot/batch no. (if required): V6N3521

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg

Doses:
2000 mg/kg
No. of animals per sex per dose:
5
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Daily
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No deaths occurred in all groups during study conducted.
Clinical signs:
Soft feces were observed in control groups of both sexes after 1 to 6 hours of administration. But no other clinical signs were evident in male and female rats.
Body weight:
No effect on the body weight was seen throughout the study period in males and females.
Gross pathology:
No effect on gross pathology was found in males and females.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not classified
DSD: not classified