Registration Dossier

Administrative data

Description of key information

Acute oral toxicity: One study is available, performed using C8 alkane sulfonate and read across to C6-8 alkane sulfonate. The study was performed on the commercial product as supplied and the LD50 (rat) was >5000 mg/kg bw, equivalent to 1550 mg a.i./kg bw. 
Acute dermal toxicity: One study is available. The reported LD50 (rat) is > 2000 mg/kg bw.
Acute inhalation toxicity: No studies are available. The substance is a solid with very low vapour pressure. It is manufactured and supplied as an aqueous solution, therefore there is no possibility of exposure to dust. It is used in some spraying applications, but it is expected that inhalation exposure from these applications will be low and hence the dermal route is more relevant.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study performed under GLP. Reliability reduced for read across.
Reference:
Composition 0
Qualifier:
according to
Guideline:
other: 16 CFR 1500.3
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes
Test material information:
Composition 1
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
Food was witheld overnight prior to dosing.
Doses:
Single dose of 5000 mg/kg
No. of animals per sex per dose:
Five male and five female
Control animals:
no
Details on study design:
- Duration of observation period following administration: 15 days
- Frequency of observations and weighing: frequently on day of dosing and daily thereafter
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross necropsy and abnormalities recorded
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 1 550 mg/kg bw
Based on:
act. ingr.
Mortality:
No premature deaths were observed during the study.
Clinical signs:
No clinical signs were observed during the study.
Body weight:
Initial weight (g) Day 15 weight
Males 255.4 +/- 9.3 345.8 +/- 20.8
Females 219.4 +/- 13.0 260.0 +/- 12.9
Gross pathology:
No abnormalities detected.
Interpretation of results:
Toxicity Category IV
Remarks:
Migrated information Criteria used for interpretation of results: EU
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
1 550 mg/kg bw
Quality of whole database:
One study (Klimisch score = 2) on the main constituent is available

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
03 - 17 October 2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study performed under GLP.
Reference:
Composition 0
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes (incl. certificate)
Test type:
standard acute method
Limit test:
yes
Test material information:
Composition 1
Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Laboratories, Research Models and Services, Germany GmbH, Sandhofer Weg 7, D-97633 Sulzfeld
- Age at study initiation: Young adult
- Weight at study initiation: 201-251 g
- Fasting period before study: none
- Housing: individually caged in Type II polypropylene/polycarbonate cages
- Diet: ad libitum - ssniff® SM R/M "Autoclavable complete diet for rats and mice – breeding and maintenance" produced by ssniff Spezialdiäten GmbH, D-59494 Soest, Germany
- Water: tap water ad libitum
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 3 °C
- Humidity: 30 - 70 %
- Air changes: 15-20/hour
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: To:
Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: Back of each animal
- % coverage: approx 10 %
- Type of wrap if used: Sterile gauze pad kept in place with an adhesive hypoallergenic plater and wrapped with a semi-occlusive plastic wrap.

REMOVAL OF TEST SUBSTANCE
- Washing: Water at body temperature
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): no data
- Concentration (if solution): not applicable
- Constant volume or concentration used: yes/no
- For solids, paste formed: yes (sample moistened with sufficient water to ensure good skin contact)

Duration of exposure:
24 h
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5 animals/sex/dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical observations on the day of treatment at 1 & 5 hours after application and once per day for 14 days thereafter. Bodyweights recorded on Day 0 (before test item administration) and on Days 7 and 14
- Necropsy of survivors performed: yes
Statistics:
Not applicable
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
act. ingr.
Mortality:
Administration of the test item at a dose level of 2000 mg/kg body weight did not cause any mortality.
Clinical signs:
No clinical signs were observed after treatment with the test item or during the 14-day observation period.
Body weight:
The body weight and body weight gain of animals did not show any test item-related effect.
Gross pathology:
There was no evidence of the test item-related observations at a dose level of 2000 mg/kg bw at necropsy. The unilateral pelvic dilatation of the kidneys, observed in two male animals is considered to be an incidental macroscopic finding.
Other findings:
There were no observed local dermal signs after treatment with the test item at a dose level of 2000 mg/kg bw.
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute dermal toxicity of the susbtance is > 2000 mg/kg bw.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
2 000 mg/kg bw
Quality of whole database:
One acute dermal toxicity study (Klimisch score =1) is available.

Additional information

Acute oral

In an acute oral toxicity study performed according to 16 CFR 1500.3, a 31% aqueous solution of C8 alkane sulfonate, the major constituent of the substance, was dosed by gavage to Sprague Dawley rats (5 animals/sex) at 5000 mg/kg bw (equivalent to 1550 mg a.i./kg bw). The animals were observed for 14 days. No deaths or clinical signs were observed during the study and no abnormalities were detected at necropsy. The LD50 (rat) was >1550 mg/kg bw [FDRL (1985)]. The results of this study can be read across to C6-8 alkane sulfonate on the basis of the identical chemical structure and similar chain length of the other main constituent, i.e. C6 alkane sulfonate.

Acute dermal

In an acute dermal toxicity study performed to OECD TG 402 under GLP, the substance was applied to the shaved backs of 5 male and 5 female CRL:(WI) rats for 24 hours under semi-occlusive conditions at a dose of 2000 mg/kg bw. The substance was moistened with water to ensure good contact with the skin. After 24 hours, any remaining substance was removed by washing with water and the animals were then observed for 14 days. At the end of the observation period, animals were necropsied and examined for macroscopic changes. There were no deaths, clinical signs or local dermal signs reported during treatment or the14 -day observation period. Body weight and body weight gains did not show any effects related to treatment with the substance. No substance-related observations were noted at necropsy. Unilateral pelvic dilatation of the kidneys, observed in two males was considered to be an incidental macroscopic finding. The LD50 (rat) was > 2000 mg/kg bw [CiToxLAB (2012)].

Acute inhalation

No data are available for the inhalation route. The substance is a solid with very low vapour pressure. It is manufactured and supplied as an aqueous solution, therefore there is no possibility of exposure to dust. It is used in some spraying applications, but it is expected that inhalation exposure from these applications will be low and hence the dermal route is more relevant.


Justification for selection of acute toxicity – oral endpoint
The test substance was tested in a GLP quality study at 5000 mg/kg (test substance at 31% active) and no deaths of adverse clinical signs were observed up to 15 days after dosing.

Justification for selection of acute toxicity – dermal endpoint
Guideline study performed under GLP using the substance itself.

Justification for classification or non-classification

Acute oral toxicity: The available study, performed using a commercial grade of C8 alkane sulfonate and read across to C6 -8 alkane sulfonate, reported an LD50 (rat) of > 5000 mg/kg bw, indicating that the commercial product as supplied should not be classified. Taking into account the concentration of alkane sulfonate present in the solution, the LD50 is > 1550 mg a.i./kg bw. This results in the classification of the pure substance as Acute Toxicity 4, with the Hazard Statement H302: Harmful if swallowed.

Acute dermal toxicity: The LD50 (rat) was > 2000 mg/kg bw in an OECD TG 402 study performed using the substance. On this basis, classification for acute dermal toxicity is not required.

Acute inhalation toxicity: No data are available. Testing was not performed as the dermal route was considered to be the most likely route of exposure.