Distillation residue, butyl alcohols production, rectification

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2010-05-30 TO 2010-07-21

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: OECD technical guideline 423 - Acute Oral Toxicity study following GLP with no deviations.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Report date:

2010

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Distillation residue, butyl alcohols production, rectification

EC Number:

931-740-0

Molecular formula:

undefined (a generic molecular formula cannot be provided for this specific UVCB substance)

IUPAC Name:

Distillation residue, butyl alcohols production, rectification

Details on test material:

A composite sample, consisting of 5 sub-samples taken over a period of 3 consecutive days, was collected directly from the process line. The volume of each sub-sample was approximately 5-10 L. The sub-samples were combined, resulting in a total volume of ca. 50 L. This ca. 50 L composite sample was split into two equal portions of ca. 25 L each (control sample and laboratory sample). The ca. 25 L laboratory sample was further split into two portions of ca. 5 L and 20 L before sending for analysis at two separate laboratories. After sampling and sample splitting, all the portions of the composite sample were stored at +4 deg Celsius.

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Accredited Breeding Velaz Prague Czech Republic
- Age at study initiation: no data
- Weight at study initiation: 190-200g females, 240-290g males
- Fasting period before study: overnight
- Housing: Animals were housed in experimental animal house on the bedding (wooden grate) in groups by maximum of 3 in cage in conformity with laboratory animals welfare legistlation.
- Diet (e.g. ad libitum): ad libitum. A standard certified laboratory diet (supplier Top Dovo, Dobra Voda) was served. The diet is routinely analysed by the manufacturer for nutritional components and environmental contaminants.
- Water (e.g. ad libitum): ad libitum
- Acclimation period: minimum 5 days.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+- 2
- Humidity (%): 55 +-10
- Air changes (per hr): minimum 10
- Photoperiod (hrs dark / hrs light): 12

IN-LIFE DATES: From: 30 May 2010 To: 21 July 2010

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Remarks:

Aqua pro inujectione (Imuna), Lot 0621VA - H2O

Details on oral exposure:

VEHICLE
- Concentration in vehicle: undiluted
- Lot/batch no. (if required): Lot 0621VA - H2O

MAXIMUM DOSE VOLUME APPLIED: 0,674 ml

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: based on the low acute toxicity of the main identified constituent 2-ethylhexanol.

Doses:

Fixed dose 2000 mg/kg bw

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 30 minutes, periodically during first 24 hours (first 4 hours), daily until 14 days. Body weights measured weekly
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology

Statistics:

No toxicity observed.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Applicant's summary and conclusion

Interpretation of results:

study cannot be used for classification

Remarks:

Migrated information

Conclusions:

The substance was recognized as orally non-toxic up to 2000 mg/kg bw in a well-established study.