Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
December 3rd, 2008 - December 26th, 2008
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report Date:
2009

Materials and methods

Test guideline
Qualifier:
according to
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

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): SH-1
- Chemical name of test material (as cited in study report): Benzene, 1,1'-(1,2-ethanediyl)bis-, brominated
- Physical state: solid
- Analytical purity: > 99%
- Batch No.: 20081010
- Expiration date of the lot/batch: 26-Oct-2010
- Stability under test conditions: stable under storage conditions

Test animals

Species:
rat
Strain:
other: HanRcc:WIST (SPF)
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Laboratories Ltd., Füllinsdorf, Switzerland.
- Age at study initiation: 11 weeks
- Weight at study initiation: 185.1 - 201.1 g
- Fasting period before study: 18-19 hours
- Housing: in groups of three in Makrolon type-4 cages
- Diet (e.g. ad libitum): Pelleted standard Provimi Kliba 3433 rat/mouse maintenance diet (Provimi Kliba AG, Kaiseraugst, Switzerland)
- Water (e.g. ad libitum): tap water
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/-3
- Humidity (%): 30-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 10-Dec-2008 To: 24-Dec-2008 and From: 12-Dec-2008 To: 26-Dec-2008

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: Polyethylene glycol 300
Details on oral exposure:
VEHICLE
- Amount of vehicle (if gavage): 0.2 g/mL
- Justification for choice of vehicle: PEG 300 was found to be a suitable vehicle chosen after a non-GLP solubility trial.
- Lot no.: 1349048

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg
Doses:
single oral dose of 2000 mg/kg bw
No. of animals per sex per dose:
3 animals per group, 2 groups of animals were treated orally
Control animals:
other: no control animals required.
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations:
Clinical signs and mortality: 30 min., 1, 2, 3 and 5 h after application on day 1 and once daily for 14 days.
Body weights: on days 1 (prior to administration), 8 and 15.
- Necropsy of survivors performed: yes, macroscopic examination on all animals during necropsy.
No organs or tissues were retained.
Statistics:
No statistical analysis was used.

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
No mortalities occured
Clinical signs:
No clinical signs were observed
Body weight:
Body weights were within the range commonly recorded for this strain and age
Gross pathology:
No macroscopic findings were recorded at necropsy

Applicant's summary and conclusion

Interpretation of results:
sligthly toxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
According to EU classification criteria, the test substance is not to be classified.
This corresponds to Category 5 for acute oral toxicity according to the OECD Globally Harmonized System (GHS) classification criteria.
Executive summary:

In an acute oral toxicity study (acute toxic class method) according to OECD guideline 423 fasted female HanRcc:WIST (SPF) rats (2 groups, 3 animals each) were administered one dose of 2000 mg/kg bw of the test substance SH-1 (Benzene, 1,1'-(1,2-ethanediyl)bis-, brominated) in PEG 300 in a volume of 10 mL/kg. The animals were observed for 14 days after administration. No mortalities and no clinical signs of toxicity occured. The acute oral LD50 for female rats was calculated to be greater than 2000 mg/kg bw.