Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
04 September 2001 to 28 January 2002
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted under GLP conditions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report Date:
2002

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
Qualifier:
according to
Guideline:
other: EC Council Directive 67/548/EEC, Annex V, Part B (1996)
Deviations:
no
GLP compliance:
yes
Test type:
acute toxic class method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report:T-7600
- Physical state: solid
- Composition of test material, percentage of components: >97%2-Propenoic acid, 2-[Methyl[(nonafluorobutyl)sulfonyl]amino]ethyl ester; <2% Water, < 0.01% Phenothiazine
- Lot/batch no.: Lot 1
- Expiration date of the lot/batch: 06 August 2002
- Stability under test conditions: not indicated
- Storage condition of test material: At room temperature in the dark.

Test animals

Species:
rat
Strain:
other: Wistar strain Crl:(WI) BR
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, Germany
- Age at study initiation: Appox. 9 weeks old
- Weight at study initiation: 205-305 g
- Fasting period before study: overnight prior to dosing and until 3-4 hours after test article administration
- Housing:- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 degrees C +/- 3 degrees C
- Humidity (%): 30-70%. Temporary deviations in maximum relative humidity are not expected to affect study integrity.
- Photoperiod (hrs dark / hrs light): 12 hours artificial fluorescent light/12 hours dark
IN-LIFE DATES: From: 04 September 2001 To: 20 September 2001

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
propylene glycol
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 2000 mg/kg/bw
- Justification for choice of vehicle: Selection based on pretest performed at NOTOX

MAXIMUM DOSE VOLUME APPLIED:
DOSAGE PREPARATION (if unusual): Prepared within 4 hours prior to dosing. Homogenicity was accomplished to a visually acceptable level. Adjustment made for specific gravity of the vehicle (specific gravity= 1.036)
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: The absence or presence of mortality of animals dosed at the intial 2000 mg/kg body weight step determined the dose of the next step.
Doses:
Single dose on day 1.
No. of animals per sex per dose:
3 animals/sex/dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Weighing on days 1 (pre-administration), 8 and 15. Clinical signs were observed at periodic intervals on day 1 and once daily until dail 15.
- Necropsy of survivors performed: Yes, on day 15
- Other examinations performed: Only clinical signs, body weight and macroscopic findings were observed.
Statistics:
No statistical analysis performed. Test substance was ranked within LD50 value ranges of 0-25, 25-200, 200-2000 or exceeding 2000 mg/kg body weight.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
approximate LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
No mortality occurred.
Clinical signs:
All females: lethargy, hunched posture, uncoordinated movements and/or chromodacyorrhoea between days 1 and 3. Males: Lethargy in all males between days 1 and 2, and hunched posture was shown by one male on days 1 and 2.
Body weight:
Mean weight gain during the study was considered to be simular to untreated animals of the same age and strain.
Gross pathology:
none

Applicant's summary and conclusion

Interpretation of results:
other: The test article does not have to be classified and has no obligatory labeling requirements for oral toxicity.
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
The oral LD50 value of the test article exceeds 2000 mg/kg body weight. The test article does not have to be classified and has no obligatory labeling requirements for oral toxicity.
Executive summary:

The acute oral toxicity of T-7600, C4 -Acrylate, in male and female Wistar rats was assessed using the Acute Toxic Class Method. The test article was administered by oral gavage to the three Wistar rats of each sex at 2000 mg//kg body weight. Animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed after terminal sacrifice. No mortality or abnormal macroscopic findings after necropsy were observed and the body weight gain shown by the animals was considered normal.Lethargy, hunched posture, uncoordinated movements and/or chromodacyorrhoea was observed in females between days 1 and 3. Lethargy in all males between days 1 and 2, and hunched posture was shown by one male on days 1 and 2.

The oral LD50 of the test article was established to exceed 2000 mg/kg body weight. Based on these results and according to EC criteria for classification and labelling requirements, the test article does not have to be classified and has no obligatory labelling requirements for oral toxicity.