Benzene, (1-methylethyl)-, oxidized, polyphenyl residues

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study with GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2015

Report date:

2015

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)

Remarks:

hameln rds a.s. Modra

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Benzene, (1-methylethyl)-, oxidized, polyphenyl residues

EC Number:

269-798-8

EC Name:

Benzene, (1-methylethyl)-, oxidized, polyphenyl residues

Cas Number:

68333-89-1

Molecular formula:

Cannot be given for UVCB

IUPAC Name:

not applicable

Test material form:

liquid: viscous

Details on test material:

Molecular Formula UVCB
Appearance Black viscous liquid

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

Source: Velaz Prague, Czech Republic
Number and Sex of Animals: 6 females
Age at First Dose: 8-12 weeks; female animals were non-pregnant and nulliparous
Animal Health The health condition of animals was examined by a veterinarian before initiation of the study.
Acclimation: The animals were acclimated under the conditions identical to the conditions during the experiment 5 days prior to the start of treatment. The acclimation was according to the standard operation procedure.
Housing Condition: The animals were housed in plastic cages suspended on stainless steel racks, up to 3 animals per cage in a room equipped with central airconditioning. The room temperature was maintained within the range of 22 ± 2° C, relative humidity within 55 ± 10 %. The light regimen
was set to a 12-hour light /12-hour dark cycle. The sanitation was performed according to the standard operation procedures.
Diet: A laboratory food Altromin (Altromin Spezialfutter GmbH, Germany) was offered in recommended doses each day approximately at the same time. The certificate of analysis is included in the raw data.
Water: The animals received tap water for human consumption. Supply of drinking was unlimited. The quality of drinking water is periodical
analysed (including microbiological control) and recorded; certificate of analysis is included in raw data.
Bedding: Lignocel S3/4, Lufa - ITL GmbH, Germany
Animals Identification: Each animal was marked with an ID number. Each cage was affixed with a cage card containing pertinent animal and study information. The animals in cages were marked by a line on the tail with an ink marker.
Justification for the Choice of Species: Normally females are used in the test according to OECD TG 423 because mostly females are the more sensitive gender.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

olive oil

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

6 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days (or other?)
- Frequency of observations and weighing:
- Necropsy of survivors performed: yes, All test animals were subjected to gross necropsy. Full, detailed gross necropsy included careful examination of external surface of the body, all orifices, and cranial, thoracic and abdominal cavities and their contents. All gross pathological changes were recorded for each animal.
- Other examinations performed:
clinical signs: Animals were observed individually immediately after the administration of the test item and then
0.5, 1, 2, and 4 hours later. Then each animal was inspected daily for the next 14 days. Observations included changes in skin and fur, eyes and mucous membranes, and also respiratory, circulatory, autonomic and central nervous systems, and somatomotor activity and behaviour pattern. Attention was directed to observations of tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma.

body weight: Individual weights of animals were determined shortly before the test item was administered and weekly thereafter. Weight differences after first and second weeks after administration were calculated and recorded.

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

>= 2 000 mg/kg bw

Based on:

test mat.

Mortality:

no

Clinical signs:

other: Animals lived through observation period without important visible signs of intoxication. Neither change of health nor negative reactions were registered.

Gross pathology:

All animals were necropsied. During necropsy, no macroscopically changes were noticed.

Applicant's summary and conclusion

Interpretation of results:

Category 5 based on GHS criteria

Remarks:

Migrated information

Conclusions:

Based on Annex 2d Test Procedure with a Starting Dose of 2000 mg/kg of OECD Guideline 423 it can be concluded that the test item High Boiler, Z-Oil is classified in Category 5/Unclassified with a LD50 cut off value equal to or greater than 5000 mg/kg, after single oral administration to Wistar rats.

Executive summary:

The test item High Boiler, Z-Oil administered to 6 females in limit dose of 2000 mg/kg did not cause death. All females survived the limit dose of 2000 mg/kg. No body weight losses were observed between one and two week after administration of the test item. No important signs of toxicity were observed at the dosage of 2000 mg/kg during the first 4 hours in females or 14 day observation period. During necropsy, no macroscopically changes were noticed.