[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:

26 April 2012 - 17 may 2012

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2012

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)

Deviations:

no

GLP compliance:

yes

Test type:

fixed dose procedure

Test material

Test material information

Constituent 1

Reference substance name:

Renewable hydrocarbons (diesel type fraction)

EC Number:

700-916-7

Molecular formula:

UVCB substance, not available. View remarks field.

IUPAC Name:

Renewable hydrocarbons (diesel type fraction)

Details on test material:

- Name of test material (as cited in study report): Diesel
- Substance type: UVCB substance
- Physical state: liquid
- Analytical purity: 100%; UVCB substance
- Lot/batch No.: 11-09149-001
- Expiration date of the lot/batch: 01 January 2013
- Storage condition of test material: room temparature in the dark

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: harlan Laboratories UK Ltd., Oxon, UK
- Age at study initiation: eight to twelve weeks
- Weight at study initiation: 155-167 g
- Fasting period before study: overnight fast immediately before dosing and for approximately three to four hours after dosing
- Housing: in groups of up to four in suspended solid-floor polypropylene cages furnished with woodflakes
- Diet (e.g. ad libitum): 2014C Teklad Global Rodent diet ad libitum
- Water (e.g. ad libitum): drinking water ad libitum
- Acclimation period: at least five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25 °C
- Humidity (%): 30 - 70 %
- Air changes (per hr): at least 15 per hour
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

Using available information on the toxicity of the test item, one animal was gavaged at a dose level of 2000 mg/kg. In the absence of toxicity, an additional group of animals (four) were gavaged at 2000 mg/kg bw. All animals were dosed once using metal cannula attached to a graduated syringe. The volume administered to each animal was calculated according to its fasted bodyweight at the time of dosing.

Doses:

2000 mg/kg bw

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: Clinical observations were made 0.5, 1, 2 and 4 hours after dosing and subsequently once daily for fourteen days. Morbidity and mortality checks were made twice daily. Individual bodyweights were recorded on Day 0 (the day of dosing) and on Days 7 and 14.
- Necropsy of survivors performed: yes/no
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other:

Results and discussion

Preliminary study:

2000 mg/kg bw was chosen as the starting dose, no mortality was observed.

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

There were no deaths (See table 1)

Clinical signs:

other: No signs of systemic toxicity were noted (See table 1)

Gross pathology:

No abnormalities were noted at necropsy (See table 3)

Other findings:

- Organ weights: not measured
- Histopathology: not examined
- Potential target organs: not observed
- Other observations: none

Applicant's summary and conclusion

Interpretation of results:

study cannot be used for classification

Conclusions:

The acute oral medial lethal dose (LD50) of the test item in the female rat was estimated to be greater than 2000 mg/kg bodyweight.

Executive summary:

The objective of this study was to assess the toxicity of the test item when administered in a single oral dose (2000 mg/kg bw) to female rats. No mortalities were observed at the tested dose level.

The study is considered reliable without restrictions since the study is carried out based on the OECD No. 420 guideline and in compliance with principles of Good Laboratory Paractice (GLP).

Based on these results, the test item does not have to be classified and has no obligatory labeling requirement for acute oral toxicity according to CLP Regulation 1272/2008 and Directive 67/548/EEC.