Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Study period:
From 21 November to 14 December 2007
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study run to method comparable with current guidelines and to GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report date:
2008

Materials and methods

Test guideline
Qualifier:
according to guideline
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

Constituent 1
Details on test material:
Batch No: E010005747 or 902/690550/A/1/1
Purity: 94.2%

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: From Charles River Deutschland GmbH Stolzenseeweg 32-36 D-88353 Kisslegg/Germany
- Age at study initiation: 11 weeks
- Weight at study initiation: 180-200 g
- Fasting period before study:
- Housing: In groups of three in Makrolon type-4 cages with wire mesh tops and standard softwood bedding
- Diet (e.g. ad libitum): Pelleted standard Provimi Kliba 3433 rat/mouse maintenance diet, ad libitum
- Water (e.g. ad libitum): Community tap water from FÜlinsdorf ad libitum
- Acclimation period:

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3℃
- Humidity (%): 30-70%
- Air changes (per hr): 10-15 air chenges per hour
- Photoperiod (hrs dark / hrs light): 12 hours light and 12 hours dark

IN-LIFE DATES: From: 21 November To: 14 December 2007

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
polyethylene glycol
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 0.2 g/mL
- Amount of vehicle (if gavage):
- Justification for choice of vehicle:
- Lot/batch no. (if required): 1310049
- Purity:
Doses:
Two groups, each of three female Sprague Dawley (SPF) rats, were treated at a dosage of 2000 mg/kg body weight.
No. of animals per sex per dose:
three females
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Body
weights were recorded on day 1 (prior to administration) and on days 8 and 15

Statistics:
No statistical analysis was used.

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No deaths occurred during the study.
Clinical signs:
other: No clinical signs were observed in the three females of the first group 1 to 5 hours post treatment or up to test day 10 in two females. However, on test day 2 a moderately ruffled fur was noted in one female which persisted and decreased to slight up to
Other findings:
Three females (Nos. 4-6) were found with a distended stomach at necropsy. Otherwise, no macroscopic findings were recorded at necropsy.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The median lethal dose of the test substance after single oral administration to female rats, observed over a period of 14 days is: LD50 (female rat): greater than 2000 mg/kg body weight.