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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2005

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
and EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
GLP compliance:
yes (incl. QA statement)
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Breeder: Janvier, Le Genest-Saint-Isle, France
- Age at study initiation: 8 weeks
- Weight at study initiation: males: 282 ± 5 g
females: 198 ± 3 g
- Fasting period before study: overnight
- Housing: one to seven of the same sex / cage during acclimation period and 3 rats of the same sex and group / cage
during the treatment period in polycarbonate cages with stainless steel lid (48 x 27 x 20 cm)
- Diet (e.g. ad libitum): ad libitum, pellets by SSNIFF Spezialdiäten GmbH, Germany
- Water (e.g. ad libitum): ad libitum, drinking water, filtered
- Acclimation period: 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2 C
- Humidity (%): 30-70 %
- Air changes (per hr): 12 / hour (filtered, non-recycled air)
- Photoperiod (hrs dark / hrs light): 12/12 h

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: MC (methylcellulose) 0.5 %
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 200 mg / ml vehicle suspension
- Amount of vehicle (if gavage): 10 ml/kg

MAXIMUM DOSE VOLUME APPLIED: 10 ml / kg

Doses:
2000 mg / kg bodyweight
No. of animals per sex per dose:
3
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations : frequently during the hours administration following then once a day
weighing: days 1, 8 and 15
- Necropsy of survivors performed: yes (macroscopic examination).
- Other examinations performed: none.

Results and discussion

Effect levelsopen allclose all
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Sex:
male
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
1 of 3 males (day 2)
Clinical signs:
-hypoactivity, piloerection, dyspnoea (males)
-none in females
Body weight:
Reversible loss of BW.
Gross pathology:
No abnormality.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU