Benzene, mono-C10-13-alkyl derivs., distn. residues

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Nov. 2, 1992-Nov. 19, 1992

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Report date:

1992

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

yes (incl. QA statement)

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Benzene, mono-C10-13-alkyl derivs., distn. residues

EC Number:

284-660-7

EC Name:

Benzene, mono-C10-13-alkyl derivs., distn. residues

Cas Number:

84961-70-6

Molecular formula:

Not available - not a single isomer, see remarks below

IUPAC Name:

Benzene, mono-C10-13-alkyl derivs., distn. residues

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Fa. Winkelmann
- Age at study initiation: 6-8 weeks
- Weight at study initiation: 143-167 g males, 129-135 g females
- Fasting period before study: 16 hrs
- Housing: up to 5 animals of the same sex in Makrolon Type III cages, identified by skin and tail markings and cage cards
- Diet (e.g. ad libitum): Ssniff R 10, ad libitum
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 30-70%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 hrs light/12 hrs dark


IN-LIFE DATES: From: Nov. 3, 1992 To: Nov. 19, 1992

Administration / exposure

Route of administration:

oral: gavage

Details on oral exposure:

A volume of 2.33 cm2/kg was applied via intubation to the animals.

Doses:

A preliminary dose of 2,000 mg/kg was given orally to 2 male and 2 female rats. For the limit test, 3 male and 3 female rats were given 2,000 mg/kg.

No. of animals per sex per dose:

Five of each sex were tested.

Details on study design:

The animals were examined for clinical symptoms 0.5, 1, 2, 3, 4, 5, and 6 hours after application, as well as once a day for two weeks. Body weight of the animals was determined on day 0, day 7, and day 14. After 14 days, the animals were sacrificed with carbon dioxide and examined macroscopically for recognizable organ defects.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

No mortality was observed during the study.

Clinical signs:

other: No adverse symptoms were observed after 14 days of observation.

Gross pathology:

There were no macroscopic abnormalities in the organs.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute oral LD50 for both male and female rats was > 2000 mg/kg bw.

Executive summary:

This study examined the acute oral toxicity of the test substance to rats. A group of 5 male and 5 female rats were given a dose of 2000 mg/kg bw test substance. The rats were then monitored over the next 14 days for clinical signs and mortality. Body weights were taken on days 0, 7, and 14 of the study. At the termination of the study, all animals were sacrificed, and examined for macroscopic abnormalities. No animals died during the study. No adverse effects to body weight or clinical signs were noted. The acute oral LD50 for male and female rats was > 2000 mg/kg bw. The test substance is not classified as toxic under EU GHS guidelines.