Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
18/05/1999-04/06/1999
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP comparable to OECD guideline
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report Date:
1999

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Principles of method if other than guideline:
/
GLP compliance:
not specified
Remarks:
the report is not complete, front page and GLP compliance is missing
Test type:
acute toxic class method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): F-2200HM
- Physical state:white powder
- Analytical purity:100%
- Lot/batch No.: 354009
- Expiration date of the lot/batch: 03/05/2000 (allocated by NOTOX, 1 year after receipt of the test substance)
- Storage condition of test material: at room temperature in the dark

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Deutschland, Germany
- Age at study initiation: +/- 10 weeks old
- Weight at study initiation: body weight not reported, body weight variation did not exceed +/- 20% of the sex mean.
- Fasting period before study: food was withheld overnight (for a max. of 20 hours) prior to dosing until approximately 3-4 hours after administration of the test substance.
- Housing: group housing of 3 animals per sex per cage in labelled polycarbonate cages containing purified sawdust as bedding material (Woody SPF, supplied by B.M.I., Helmond, The Netherlands.
- Diet (e.g. ad libitum):ad libitum
- Water (e.g. ad libitum):ad libitum
- Acclimation period: 5 days before start of treatment under laboratory conditions

ENVIRONMENTAL CONDITIONS
- Temperature (°C):21°C
- Humidity (%):50%
- Air changes (per hr):15
- Photoperiod (hrs dark / hrs light):12hrs light/12hrs dark

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
propylene glycol
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 2g in 10ml
- Amount of vehicle (if gavage):10ml/kg bw
- Justification for choice of vehicle: the vehicle was slected based on a pretest performed at NOTOX

DOSAGE PREPARATION (if unusual): the formulations were prepared within 4 hours prior to dosing. Homogeneity was accomplished to a visually acceptable level. Adjustement was made for specific gravity of vehicle.

Doses:
2000mg/kg (10ml/kg)
No. of animals per sex per dose:
3
Control animals:
no
Details on study design:
- Duration of observation period following administration: 15 days
- Frequency of observations and weighing: at periodic intervals on the day of dosing (day 1) and once daily thereafter, until day 15. Body weight: day 1, 8 and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, mortality/viability
Statistics:
no statistical analysis was performed

Results and discussion

Preliminary study:
/
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
no mortality occured
Clinical signs:
Lethargy and uncoordinated movements were noted in all animals on day 1 and in addition hunched posture was noted in all females on day 2.
Body weight:
The body weight gain shown by the animals over the study period was considered to be similar to that expected of normal untreated animals of the same age and strain.
Gross pathology:
No abnormalities were found at macroscopic post mortem examination of the animals.
Other findings:
/

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The oral LD50 value of F-2200HM in Wistar rats was established to exceed 2000mg/kg body weight.
Executive summary:

Assessment of acute oral toxicity with F-2200HM in the rat (Acute Toxic Class Method).

The study was carried out based on the guideline described in: EC Commission Directive 96/54/EC, Part B.1 tris 'Acute Oral, Acute Toxic Class method' and OECD no. 423, "Acute Oral Toxicity - Acute Toxic Class Method".

F-2200HM was administered by oral gavage to three Wistar rats of each sex at 2000mg/kg bw. Animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed after terminal sacrifice (day 15).

No mortality occured.

Lethargy and uncoordinated movements were noted in all animals on day 1 and in addition hunched posture was noted in all females on day 2.

The body weight gain shown by the animals over the study period was considered to be normal.

No abnormalities were found at macroscopic post mortem examination of the animals.

The oral LD50 value of F-2200HM in wistar rats was established to exceed 2000mg/kg bw.

Based on these results and according to the EC criteria for classification and labelling requirements for dangerous substances and preparations (Guidelines in Commision Directive 93/21/EEC), F-2200HM does not have to be classified and has no obligatory labelling requirement for oral toxicity.