1-bromododecane

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2003

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2003

Report date:

2003

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

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:

1-bromododecane

EC Number:

205-587-9

EC Name:

1-bromododecane

Cas Number:

143-15-7

Molecular formula:

C12H25Br

IUPAC Name:

1-bromododecane

Test material form:

other: Liquid

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals or test system and environmental conditions:

A group of three fasted females was treated with the test material at a dose level of 2000 mg/kg bodyweight. This was followed by a further group of three fasted females at the same dose level.
The temp and relative humidity were set to achieve limits of 19 to 25deg C and 30 to 70% respectively. The rate of air axchange was at least 15 changes per hour and the lighting was controlled by a time switch to give 12 hourse continuous light and 12 hours darkenss.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: undiluted

Details on oral exposure:

A group of three fasted females was treated with the test material at a dose level of 2000 mg/kg bodyweight. This was followed by a further group of three fasted females at the same dose level.

Doses:

2000 mg/kg body weight

No. of animals per sex per dose:

A group of three fasted females was treated with the test material at a dose level of 2000 mg/kg bodyweight. This was followed by a further group of three fasted females at the same dose level.

Control animals:

no

Details on study design:

The test material was administered orally undiluted. Clinical signs and bodyweight development were monitored during the study. All animals were subjected to gross necropsy.

Statistics:

NA

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 500 mg/kg bw

Based on:

test mat.

Mortality:

Individual mortality data are given in Table 1 in the attachment

Clinical signs:

other: Individual clinicla observations are given in Table 2 in the attachment.

Gross pathology:

Individual necropsy findings are given in Table 4 in the attachment. No abnormalities were noted at necropsy.

Applicant's summary and conclusion

Interpretation of results:

study cannot be used for classification

Remarks:

Migrated information

Conclusions:

LD50 > 2500 mg/kg body weight.
The test material does not meet the criteria for classification.

Executive summary:

Introduction. The study was performed to assess the acute oral toxicity of the test material following a single oral administration in the Sprague-Dawley CD (Cr!: CD® (SD) IGS BR) strain rat. The method was designed to meet the requirements of the following:

• OECD Guidelines for the Testing of Chemicals No. 423 “Acute Oral Toxicity — Acute Toxic Class Method” (adopted 17 December 2001)

Method. A group of three fasted females was treated with the test material at a dose level of 2000 mg/kg bodyweight. This was followed by a further group of three fasted females at the same dose level.

The test material was administered orally undiluted. Clinical signs and bodyweight development were monitored during the study. All animals were subjected to gross necropsy.

Mortality. There were no deaths.

Clinical Observations. There were no signs of systemic toxicity.
Bodyweight. All animals showed expected gains in bodyweight over the study period.

Necropsy. No abnormalities were noted at necropsy.