Hydrocarbons, C4-7, C5-rich, isoprene-purifn. by-product

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

May to August 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 A4

IUPAC Name:

Absorbent A4

Details on test material:

- Name of test material (as cited in study report): Absorbent A4
- Substance type: UVCB
- Physical state: Transparent liquid without mechanical impurities, colour from light to dark
- 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 154g 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: 3 animals survived showing slight signs of toxicosis, 3 other animals died within 24 hrs

Mortality:

All six animas survived the treatment with the test item at a dosis of 300 mg/kg bw.
3 animas survived the treatment with the test item at a dosis of 2000 mg/kg bw. 3 other animals died within 24 hrs 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 animals No. 1 to 9 in the necropsy.
The animal No. 10 had cramped limbs, slight bloody discharge from nose and mouth, a stomach filled partly with food and gas, petechial bleedings in the lungs as well as a slight edematous small intestine.
Cramped limbs, slight bloody discharge from nose and mouth as well as a stomach filled partly with food and gas were also revealded in rat No. 11. Furthermore, the mucosa of the jejunum was hemorrhagic centrally and the content was sero hemorrhagic.
The animal No. 12 showed cramped limbs, slight bloody discharge from nose and mouth, petechial bleedings in the lungs, an edematous small intestine and slight sero hemorrhagic content.

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Remarks:

Migrated information

Conclusions:

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

Executive summary:

The oral LD50 of the test item in rats was found to be 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 4.