Registration Dossier

Administrative data

Description of key information

Acute toxicity via Oral route

One reliable study with restrictions is available. The study was conducted on rats according a test method similar to the one described in OECD guideline No. 401.

No mortality and no signs of significant toxic effects were observed.

Fluorosulfonic Adduct showed an Approximate Lethal Dose (ALD) higher than 7500 mg/kg bw.

 

Acute toxicity via Dermal route

No studies available. The assessment of Acute toxicity via Dermal route is done on the basis of physical and chemical properties and available data.

Fluorosulfonic Adduct is not expected to have a LD50 (rat) lower or equal to 5000 mg/kg bw.

 

Acute toxicity via Inhalation route

No studies available

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
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
Qualifier:
equivalent or similar to
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
Species:
rat
Strain:
other: CD®(SD)BR
Sex:
male
Details on test animals 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
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.
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

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
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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
Value:
5 000 mg/kg bw
Quality of whole database:
One acute toxicity study by oral route is available, reliable with restrictions (test method similar to OECD 401 with deviations, no GLP) and considered acceptable for assessment.

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Acute toxicity via Oral route

One acute toxicity study by oral route is available. The study was conducted on rats, the study design was similar to the test method described in OECD guideline No.401(1987) with some deviations: only 1 animal/dose tested, only male sex tested, no gross pathology examination performed. The study was not conducted under GLP.

Although the described deviations from the OECD guideline, the study was conducted in accordance with generally accepted scientific principles, well documented and described in sufficient details. It is considered acceptable for assessment.

No mortality was observed in rats tested up to the highest dose (7500 mg/kg). No significant toxic effects were observed.

The LD50 (rat) of Flurosulfonic adduct is > 5000 mg/kg.

 

Acute toxicity via Dermal route

No Acute Toxicity study by Dermal route are available for Fluorosulfonic Adduct.

As described in the ECHA Guidance on Information Requirements and Chemical Safety Assessment Chapter R.7.a_v.6.0, in some cases, it may be possible to draw conclusions about the potential for acute dermal toxicity without testing, on the basis of the data available from acute oral toxicity and/or dermal absorption information.

Dermal absorption is influenced by many factors, among them, the physico-chemical properties of the substance. As described in the ECHA Guidance on Information Requirements and Chemical Safety Assessment Chapter R.7.c_v.3.0, the following parameters can be considered for assessing the skin absorption potential: Physical state, molecular weight, structure, water solubility, Log Kow, Vapor pressure, Surface tension, Skin Irritation/Corrosion data and other animal study involving dermal administration, presence of cationic trace elements:

·       liquids are taken up more readily than dry particulates but absorption of volatile liquids across the skin may be limited by the rate at which the liquid evaporates off the skin surface.

·       Molecular weight less than 100 favors dermal uptake. Above 500 the molecule may be too large.

·       As a result of binding to skin components the uptake of substances with the following groups can be slowed:

-       certain metal ions, particularly Ag+, Cd2+, Be2+ and Hg2+

-       acrylates, quaternary ammonium ions, heterocyclic ammonium ions, sulphonium salts.

A slight reduction in the dermal uptake of substances belonging to the following chemical classes could also be anticipated for the same reason:

-       Quinines, dialkyl sulphides, acid chlorides, halotriazines, dinitro or trinitro benzenes.

·       If the water solubility is below 1 mg/l, dermal uptake is likely to be low.

·       For substances with log P values <0, poor lipophilicity will limit penetration into the stratum corneum and hence dermal absorption. For substances with log Kow above 4, the rate of penetration may be limited by the rate of transfer. Log P values between 1 and 4 favour dermal absorption (values between 2 and 3 are optimal) particularly if water solubility is high.

·       Substances with vapour pressures above 100-10,000 Pa (ca. 0.76-76 mm Hg) at 25 may be too volatile to penetrate further the stratum corneum.

·       If the substance is a surfactant and this will enhance the potential dermal uptake.

·       If the substance is a skin irritant or corrosive, damage to the skin surface may enhance penetration.

Fluorosulfonic Adduct has a molecular weight of 351 g/mol, it is a volatile liquid with vapor pressure of 1828 Pa at 20°C, it has a low water solubility (ws = 0.388 mg/L), a log Kow = 1.9 and no surface tension properties. Moreover it was tested in an in-vitro system for skin irritation resulting to be not-irritant and not-corrosive for the skin. 

Basing on its physical-chemical properties, the rate of absorption through the skin is anticipated to be limited for Fluorosulfonic Adduct.

Considering the lack of mortality and evident signs of systemic toxicity following oral administration up to 7500 mg/kg and the limited potential of dermal absorption, Fluorosulfonic Adduct is not anticipated to be able to have an LD50 (rat) below 5000 mg/kg following dermal application.

 

Acute toxicity via Inhalation route

No studies available

Justification for classification or non-classification

Acute toxicity via Oral route

Fluorosulfonic Adduct does not fulfilled the classification criteria according to Regulation (EC) 1272/2008 (EU GHS) and UN GHS rev.6.

Acute toxicity via Dermal route

Fluorosulfonic Adduct does not fulfilled the classification criteria according to Regulation (EC) 1272/2008 (EU GHS) and UN GHS rev.6.

Acute toxicity via Inhalation route

No data available.