Bottom residues resulting from dimethylformamide regenaration and separation of piperylene and benzene in the synthesis of isoprene from dehyrdogenation of isopentane

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

May to September 2011

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Test performed according to OECD/EU testing guideline and GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2011

Report date:

2011

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

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Absorbent N grade B

IUPAC Name:

Absorbent N grade B

Details on test material:

- Name of test material (as cited in study report): Absorbent N grade B
- Substance type: UVCB
- Physical state: Brown liquid
- Stability under test conditions: months
- Storage condition of test material: room temperature, in the dark

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: from the copany Charles River Deutschland GmbH, D-97633, Sulzfeld
- Age at study initiation: data not available
- Weight at study initiation: between 152g and 180g
- Fasting period before study: yes
- Housing: the rats were kept in transparent macrolone cages (type 3-180, floor area 810 cm2) with 3 in each cage. the cages were cleaned and the bedding changed at least twice a week.
- Diet: free access to a pelleted diet "Altromin 1324"
- Water: free access to bottles of drink water of domestic quality, which was acidified with hydrochloric acid to pH 2.5 in order to prevent microbial growth
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 22 +/- 3°C
- Humidity: at least 30% and preferably not exceed 70%
- Air changes: 10 times/hour
- Photoperiod: 12 hrs dark / 12 hrs light

IN-LIFE DATES: From 24-MAY-2011 to 31-MAY-2011

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

olive oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: data not available
- Amount of vehicle (if gavage): 10 ml/kg bw
- Justification for choice of vehicle: data not available

MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg bw

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: data not available

Doses:

300 mg/kg bw and 2000 mg/kg bw

No. of animals per sex per dose:

4 x 3 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
> each rat was observed 30 minutes, 2 hrs, 4hrs and 6hrs after the administration and therafter daily for a period of 14 consecutive days
> the body weight was determined on days 0, 7 and 14
- Necropsy of survivors performed: yes

Statistics:

not applicable

Results and discussion

Effect levels

Effect levels 1

Sex:

female

Effect level:

300 mg/kg bw

Based on:

test mat.

Remarks on result:

other: All 6 animals survived not showing severe signs of toxicosis

Effect levels 2

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: All 6 animals survived showing signs of toxicosis ranging between slight and severe.

Mortality:

All six animas survived the treatment with the test item at a dosis of 300 mg/kg bw.
All six animas survived the treatment with the test item at a dosis of 2000 mg/kg bw.

Clinical signs:

other: On the day of application after 30 minutes and 2 hrs piloerection was observed in animal No. 1, No. 2 and No. 3 (group 1) receiving a dose of 300 mg/kg b.w. After 4 hrs and 6 hrs as well as from day 1 to the end of the observation period on day 14 all ani

Gross pathology:

There were no pathological signs detected in the necropsy, with exception of animal No. 10.
This rat showed slight oedematous and reddened mucosa of the duodenum, slightly reddened mesenteric fat, a well filled gastrointestinal tract and a slightly oedematous and reddened pancreas. These findings suggested the suspicion that a slight pancreatitis and enteritis of the duodenum were present.

Applicant's summary and conclusion

Interpretation of results:

Category 5 based on GHS criteria

Remarks:

Migrated information

Conclusions:

oral LD50 (rat, females) above 2000 mg/kg bw

Executive summary:

The oral LD50 of the test item in rats was found to be above 2000 mg/kg bw under the experimental conditions described in the final report. In accordance with the GHS, the test item should be categorized into category 5.