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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 02-October-1996 to 22-October-1996
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report date:
1996

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
1 animal / dose - only male sex tested / necropsy not perfomed.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
2-(1,2-dichloro-1,2,2-trifluoroethoxy)-1,1,2,2-tetrafluoroethanesulfonyl fluoride
EC Number:
604-439-4
Cas Number:
144728-59-6
Molecular formula:
C4Cl2F8O3S
IUPAC Name:
2-(1,2-dichloro-1,2,2-trifluoroethoxy)-1,1,2,2-tetrafluoroethanesulfonyl fluoride
Test material form:
liquid
Details on test material:
See confidential details on test material

Test animals

Species:
rat
Strain:
other: CD®(SD)BR
Sex:
male
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Laboratories, Raleigh, North Carolina
- Age at study initiation: approximately 7 weeks old
- Weight at study initiation: 268 - 300 g
- Housing: singly in suspended, stainless steel, wire-mesh cages
- Diet: ad libitum (Purina® Certified Rodent Chow® #5002)
- Water: ad libitum
- Acclimation period: one week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23°C ± 1°C
- Humidity (%): 50% ± 10%
- Air changes (per hr): not specified
- Photoperiod (hrs dark / hrs light): 12-hour light/12-hour dark cycle

IN-LIFE DATES: From: 03 October 1996 To: 18 October 1996

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
VEHICLE
- Concentration in vehicle: not applicable. The substance was administered undiluted.

MAXIMUM DOSE VOLUME APPLIED: 1.2 mL of undiluted test item, corrisponding to the dose of 7500 mg/kg, bw = 280 g
MINIMUM DOSE VOLUME APPLIED: 0.10 mL of undiluted test item, corrisponding to the dose of 670 mg/kg, bw = 268 g
(density = 1.7124 g/ml)
Doses:
Concentrations: 670, 1500, 2300, 3400, 5000 and 7500 mg/kg
No. of animals per sex per dose:
1
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Following administration of the test substance, rats were observed for clinical signs of toxicity. Observations for mortality and signs of illness, injury, or abnormal behavior were made daily throughout the study. Rats were weighed and observed at least 3 times a week throughout the 14-day observation period.
- Necropsy of survivors performed: no
- Other examinations performed: clinical signs, body weight.

Results and discussion

Effect levels
Key result
Sex:
male
Dose descriptor:
other: Approximate Lethal Dose
Effect level:
> 7 500 mg/kg bw
Based on:
test mat.
Mortality:
No deaths occurred
Clinical signs:
No clinical signs of toxicity
Body weight:
No evidence of changes in body weight related to the treatment
Gross pathology:
not performed

Any other information on results incl. tables

The dosage regimen and the mortality over the 15 -day test period are detailed below.

 Dosage (mg/kg)  Dose volume (mL)  Density (mg/mL)  Initial body weight (g)  Mortality
 670  0.10  1712.4  268  No
 1500  0.26  1712.4  300  No
 2300  0.34  1712.4  268  No
 3400  0.55  1712.4  278  No
 5000 0.79  1712.4  272  No
 7500  1.2  1712.4  280  No

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the conditions of this study, the Approximate Lethal Dose (ALD) for the test item was greater than 7500 mg/kg of body weight. No deaths occurred, and no clinical signs of toxicity were observed during the study. This substance is considered to be very low in toxicity (ALD greater than 5000 mg/kg) when administered as a single oral dose to male rats.
Executive summary:

The assessment of acute oral toxicity of Fluorosulfonic Adduct in the rat was carried out according to a protocol simlilar to the guideline described in: OECD No.401 (1987).

The test substance was administered neat to 1 rat per dose rate by intragastric intubation. Dose rates administered ranged from 1500 to 7500 mg/kg of body weight in increments of approximately 50%. Additionally, 1 rat was dosed at 670 mg/kg. Following administration of the test substance, rats were observed for clinical signs of toxicity. Rats were weighed and observed at least 3 times a week throughout the 14-day observation period. Observations for mortality and signs of illness, injury, or abnormal behavior were made daily throughout the study. Pathological examinations of test animals were not performed.

Under the conditions of this study, the ALD for the test item was greater than 7500 mg/kg of body weight. No deaths occurred, and no clinical signs of toxicity were observed during the study. This substance is considered to be very low in toxicity (ALD greater than 5000 mg/kg) when administered as a single oral dose to male rats.

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