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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
Study period:
1984-02-07 to 1984-02-22
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable well-documented study report which meets basic scientific principles and was performed according to internationally accepted testing guidelines.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984
Report date:
1984

Materials and methods

Test guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Diisotridecyl phthalate
EC Number:
248-368-3
EC Name:
Diisotridecyl phthalate
Cas Number:
27253-26-5
Molecular formula:
C34H58O4
IUPAC Name:
1,2-bis(2-methyldodecyl) benzene-1,2-dicarboxylate
Details on test material:
- Name of test material (as cited in study report): Vestinol TD stabilised with 0.5% Bisphenol A
- Substance type: product
- Impurities (identity and concentrations): 0.4% Tridecanole, 0.45% Bisphenol A
- Physical state: liquid
- Lot/batch No.: T 53/124312173
- Other: Date of production: 1983-09-01

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Winkelmann, Borchen, Germany
- Age at study initiation: not mentioned
- Weight at study initiation: mean body weights: 127 g (males), 126 g (females)
- Fasting period before study: 16 hours
- Housing: 1 - 5 animals in Makrolon cages, type III
- Diet: R10 Complete feed for rats ad libitum, supplied by Ssniff Spezialfutter GmbH, Soest, Germany
- Water: Drinking water ad libitum
- Acclimation period: 4 - 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 1
- Humidity (%): 60 ± 5
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 1984-02-07 To: 1984-02-22

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
DOSE VOLUME APPLIED: 10.5 mL/kg
Doses:
10000 mg/kg b.w.
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Examination of clinical signs and time of deaths up to 6 hours after the treatment
and daily observations thereafter; body weights were determined before treatment, and 1, 7 and 14 days after treatment.
- Necropsy of survivors performed: yes
- Other examinations performed: no
Statistics:
The means of the body weights were calculated.
The LD50 was determined according to Litchfield and Wilcoxon and reported with 95% confidence limits (J. Pharmacol. Exp.
Ther. 96, 1949, 99)

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 10 000 mg/kg bw
Mortality:
no deaths occurred during study (see table 1)
Clinical signs:
other: 30 minutes after application ruffled fur, squatting position and diuresis were noted. After 48 hours all animals were free of symptoms.
Gross pathology:
No pathological changes of organs were found at necropsy.

Any other information on results incl. tables

Dose

 

(mg/kg

bw)

Mortality (# dead/total)

Time

range of

deaths

(hours)

Number with evident toxicity

(#/total)

Male

Female

Combined

Male

Female

Combined

10000

0/5

0/5

0/10

-

5/5

5/5

10/10

 

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Remarks:
Migrated information
Conclusions:
No evidence of acute oral toxicity.
Executive summary:

Male and female Wistar rats were administered a single oral exposure of DTDP (10 g/kg) via oral gavage after an 16 hour fasting period. Assessment for clinical signs of toxicity up to 6 hours after dosing and daily thereafter for 14 days. All animals survived the exposure. There was no evidence of a wasting syndrome as assessed by changes in bodyweight. Clinical signs of ruffled fur, squatting position and diuresis were observed 0.5 hours post exposure in some dose groups, but these signs were not present by 2 days post exposure. It is concluded that the LD50 is greater than 10.0 g/kg.

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