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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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)
Rationale for reliability incl. deficiencies:
other: Conducted at GLP-accredited facility to current guidelines

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
fixed dose procedure
Limit test:
yes

Test material

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River (UK) Ltd, Margate, Kent, UK
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 206-244 g
- Fasting period before study: overnight
- Housing: groups up to 4 in suspended floor polypropylene cages furnished with woodflakes
- Diet (e.g. ad libitum): Certified Rat and Mouse Diet access ad libitum, with the exception of the overnight period prior to dosing and 3-4 hours post-dosing
- Water (e.g. ad libitum): mains tap water access ad libitum, with the exception of the overnight period prior to dosing and 3-4 hours post-dosing
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25
- Humidity (%): 30-70
- Air changes (per hr): at least 15
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: 21 March 2007 To: 18 April 2007

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 30 mg/ml in arachis oil for 300 mg/kg dose level, at the 2000 mg/kg dose level the test material was administered undiluted
- Amount of vehicle (if gavage): 10 ml/kg, 2.15 ml/kg undiluted material for 2000 mg/kg
- Justification for choice of vehicle: test material is not soluble and did not suspend in water


MAXIMUM DOSE VOLUME APPLIED: 2000 mg/kg
Doses:
300 and 2000 mg/kg
No. of animals per sex per dose:
1 female (300 mg/kg)
5 females (2000 mg/kg)
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: clinical observations at 0.5, 1, 2, 4 hours after dosing and then daily thereafter, bodyweights measured on days 0, 7 and 14
- Necropsy of survivors performed: yes (gross)
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: clinical observations, body weight
Statistics:
None recorded

Results and discussion

Preliminary study:
There were no signs of toxicity in the one female adminstered 300 mg/kg of the test material over the 14 day observation period. The animal showed expected gains in bodyweight. No abnormalities were noted at necropsy.
Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
None
Clinical signs:
other: None
Gross pathology:
No gross abnormalities noted at necropsy

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Remarks:
Migrated information
Conclusions:
The LD50 of the test material in the female rat is >2000mg/kg bw. At this dose there were no signes of toxicity in terms of survival, body weight gain, behaviour, or gross pathology.