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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
November 1995-January 1996
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study done using OECD guidelines

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report date:
1996

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Qualifier:
according to guideline
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
GLP compliance:
yes (incl. QA statement)
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
2,2',6,6'-Tetrabromo-4,4'-isopropylidenediphenol, oligomeric reaction products with 1-chloro-2,3-epoxypropane and 2,4,6-tribromophenol
EC Number:
500-399-6
EC Name:
2,2',6,6'-Tetrabromo-4,4'-isopropylidenediphenol, oligomeric reaction products with 1-chloro-2,3-epoxypropane and 2,4,6-tribromophenol
Cas Number:
158725-44-1
IUPAC Name:
NA
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
F-3014, batch number 016, received 2 October 1995, description white solid, storage conditions 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: Charles river (UK) Ltd
- Age at study initiation: 8-12 weeks
- Weight at study initiation: males 264-280 gr; females 200-242 gr
- Fasting period before study: overnight before dosing and 2 hr after dosing
- Housing: animals were housed in groups of up to five by sex in solid-floor polypropylene cages furnished with woodflakes.
- Diet (e.g. ad libitum): mouse and rat No 1 special diets services Limited WithamEssex (UK) was allowed during the study
- Water (e.g. ad libitum): mains drinking water.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-22
- Humidity (%): 44-58
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12-12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
All animals were dosed once by gavage using metal cannula attached to graduated syringe.
The volume administrated to each animal was calculated according to its fasted bodyweight at the time of dosing.
Doses:
Range finder: Dose level 5000 mg/kg, Concentration 500 mg/ml, Dose volume 10 ml/kg
Main test: Range finder: Dose level 5000 mg/kg, Concentration 500 mg/ml, Dose volume 10 ml/kg
No. of animals per sex per dose:
Range finder, one male and one female
Main test: five males and five females
Control animals:
no
Details on study design:
- Duration of observation period following administration: range finder 5 days; main study 14 days
- Frequency of observations and weighing: 0.5, 1,2 and 4 hr after dosing and subsequently once daily for 5/14 days . Range finder: Individual bodyweights were recorded on the day of dosing to allow calculation of individual treatment volumes.
Main study: individual bodyweights were recorder prior to dosing on day 0 and on day 7 and 14.
- Necropsy of survivors performed:Range finder: no; Main test: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: Main test: gross pathological examination, e.g external examination and opening of the abdominal and thoractic cavities for examination of major organs.

Results and discussion

Preliminary study:
There were no deaths or clinical signs of toxicity
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
no deaths
Clinical signs:
no signs of systemic toxicity
Body weight:
all animals showed expected gain in bodyweight during the study
Gross pathology:
no abnormalities were noted at necropsy

Any other information on results incl. tables

see attached file (tables)

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information non toxic Criteria used for interpretation of results: EU
Conclusions:
The acute oral median lethal dose (LD50) of the test material, F-3014, in the Sprague-Daweley CD strain rat was found to be greater than 5000 mg.kg bodyweight.
No symbol and risk phrase are required according to the EU labelling regulations
Executive summary:

The acute oral median lethal dose (LD50) of the test material, F-3014, in the Sprague-Daweley CD strain rat was found to be greater than 5000 mg.kg bodyweight.

No symbol and risk phrase are required according to the EU labelling regulations