Benzene, ethylenated, residues, distn. lights

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

IN-LIFE DATES: From: 1 July 2002 To: 18 July 2002

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study was carried out according to OECD guideline 423 and EU Method B1 and follows GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Report date:

2002

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:

ethylbenzene

EC Number:

700-371-5

Cas Number:

178535-25-6

IUPAC Name:

ethylbenzene

Details on test material:

- Name of test material (as cited in study report): Ethylbenzene, manuf. of, distn. residues, distn. lights.
- Substance type: Solvent for petroleum additives
- Physical state: Clear light yellow liquid
- Purity test date: 100%
- Lot/batch No.: P0204-1936
- Stability under test conditions: Stable for the duration of the study (single dose only prepared on the day of dosing)
- Storage condition of test material: Room temperature

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan U.K. Ltd, Bicester, Oxon, UK
- Age at study initiation: 5-7 weeks of age
- Weight at study initiation: 87 - 117 g
- Fasting period before study: overnight prior to dosing and 4 hours after dosing
- Housing: Housed in groups of 3 in metal cages with wire mesh floors
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: 5 days prior to the start of treatment

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3C
- Humidity (%): 40 - 70%
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12 hours light/ 12 hours dark

IN-LIFE DATES: From: 1 July 2002 To: 18 July 2002

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 200 mg/mL
- Amount of vehicle (if gavage): 15 g using a glass syringe and metal cannula

MAXIMUM DOSE VOLUME APPLIED: Appropriate dose volume of the test substance was administered

DOSAGE PREPARATION (if unusual):

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: The starting dose was 2000 mg/kg bw as per the guideline.

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

3 animals/sex

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed at frequent intervals in the day of dosing and twice day thereafter until Day 15. Mortality/viability were checked ar least twice daily for any mortalities. Bodyweight was recorded on prior to dosing and once a week thereafter.
- Necropsy of survivors performed: yes
- Other examinations performed: All animals were subjected to a macrospcopic examination at study termination on day 15.

Statistics:

No statistical method was used since it is a limit test.

Results and discussion

Preliminary study:

The study is a limit test.

Effect levels

Effect levels 1

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Effect levels 2

Sex:

male

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred during the course of the study.

Clinical signs:

other: Clinical signs such as confined to light purple coloured urine was reported in all animals and persisted until day 4. Salivation and brown staining to the muzzle of two males and piloerection and hunched posture observed in one male. All animals had recov

Gross pathology:

No abnormalities were reported during macroscopic examination

Other findings:

All other findings were reported.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute lethal oral dose (LD50) to rats of Ethylbenzene, manuf. of, distn. residues, distn. lights. was demonstrated to be greater than 2000 mg/kg bw. On this basis, Ethylbenzene, manuf. of, distn. residues, distn. lights. does not warrant any classification according to Directive 67/548/EEC and Regulation (EC) No 1272/2008

Executive summary:

A group of three fasteed female rats were administered a single oral gavage dose of Ethylbenzene, manuf. of, distn. residues, distn. lights. at 2000 mg/kg bw. Animals were monitored for mortality and clinical signs at frequent intervals on the day of dosing and twice a day thereafter until Day 15. Bodyweights were recorded prior to dosing and on days 8 and 15. Gross necropsy was carried out on day 15. Clinical signs were confined to confined to light purple coloured urine was reported in all animals and persisted until day 4. Salivation and brown staining to the muzzle of two males and piloerection and hunched posture observed in one male. All animals had recoved by day 4 and gained weights throughout the course of the study. No abnormalities were recorded at macroscopic examination. The acute lethal oral dose (LD50) to rats of Ethylbenzene, manuf. of, distn. residues, distn. lights. was demonstrated to be greater than 2000 mg/kg bw. On this basis, Ethylbenzene, manuf. of, distn. residues, distn. lights. does not warrant any classification according to Directive 67/548/EEC and Regulation (EC) No 1272/2008