[No public or meaningful name is available]

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

not mentioned

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Test substance not described in sufficient details, only tested at one sex

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1972

Report date:

1972

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

Study conducted before OECD guideline was established, only one sex tested

Principles of method if other than guideline:

Study conducted similar to today's standards: male Wistar rats were applicated once per oral gavage with test substance in several concentrations, observed for 14 days and then dissected.

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

bis(decyl and/or dodecyl) benzene-1,2-dicarboxylate

EC Number:

931-251-2

Molecular formula:

C28H46O4 - C32H54O4

IUPAC Name:

bis(decyl and/or dodecyl) benzene-1,2-dicarboxylate

Details on test material:

- Name of test material (as cited in study report): Witamol 112
- Substance type: product
- Physical state: liquid
- Other: none

Test animals

Species:

rat

Strain:

Wistar

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: accepted breeder
- Age at study initiation: not mentioned
- Weight at study initiation: 115 - 140 g
- Fasting period before study: overnight
- Housing: 2 animals in one cage, no further details
- Diet (e.g. ad libitum): ssniff R complete feed for rats, supplied by INTERMAST GmbH, Bockum-Hövel, Germany
- Water (e.g. ad libitum): ad libitum
- Acclimation period: no data


ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data


IN-LIFE DATES: no data

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 5.6 mL

Doses:

5, 10, 20, 30, 40 mL/kg body weight

No. of animals per sex per dose:

5 mL/kg bw: 12
10 mL/kg bw: 12
20 mL/kg bw: 12
30 mL/kg bw: 12
40 mL/kg bw: 10

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations: 1 and 4 hours after dosing and subsequently daily, frequency of weighing not mentioned
- Necropsy of survivors performed: yes, no tissues remained
- Other examinations performed: Deaths and overt signs of toxicity were recorded.

Statistics:

not performed

Results and discussion

Effect levels

Sex:

male

Dose descriptor:

LD50

Effect level:

> 40 mL/kg bw

Mortality:

- Number of deaths at each dose:
5 mL/kg bw: 0/12
10 mL/kg bw: 0/12
20 mL/kg bw: 0/12
30 mL/kg bw: 0/12
40 mL/kg bw: 0/10

Clinical signs:

other: no abnormalities detected

Gross pathology:

no abnormalities detected

Other findings:

none

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU