Sulfonic acids, C14-18-alkane hydroxy and C12-20-alkapolyene and C14-18-alkene and C12-20-alkene hydroxy, sodium salts

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

06 September 2017 - 02 Ocober 2017

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2017

Report date:

2017

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Sulfonic acids, C14-18-alkane hydroxy and C12-20-alkapolyene and C14-18-alkene and C12-20-alkene hydroxy, sodium salts

EC Number:

273-105-4

EC Name:

Sulfonic acids, C14-18-alkane hydroxy and C12-20-alkapolyene and C14-18-alkene and C12-20-alkene hydroxy, sodium salts

Cas Number:

68937-98-4

IUPAC Name:

Sulfonic acids, C14-18-alkane hydroxy and C12-20-alkapolyene and C14-18-alkene and C12-20-alkene hydroxy, sodium salts

Test material form:

solid: particulate/powder

Details on test material:

- Moisture content: 5% max

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Envigo RMS
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 8-12 weeks

- Weight at study initiation: 140-169 g

- Fasting period before study: Overnight fasting immediately before dosing and for approximately 3 to 4 hours after dosing
- Housing: groups of 4
- Diet: ad libitum
- Water: ad libtum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25°C
- Humidity (%): 30-70%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 30-200 mg/mL
- Amount of vehicle : 10mL
MAXIMUM DOSE VOLUME APPLIED: 10mL/kg

Doses:

300mg/kg, 2000mg/kg

No. of animals per sex per dose:

5 females were treated at a dose level of 300 mg/kg

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 30mins, 1,2,4 hours, and then daily up to 14 days
- Frequency of weighing: day 0, 7 and 14
- Necropsy of survivors performed: yes

Statistics:

not specified

Results and discussion

Preliminary study:

dose level of 2000mg/kg - the animal was found dead on day 1

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

ca. 300 - ca. 2 000 mg/kg bw

Based on:

test mat.

Mortality:

1 aminal found dead at a dose level of 2000 mg/kg
No mortality at dose level of 300 mg/kg

Clinical signs:

other: Hunched posture was noted at the 4 hours after dosing at dose level of 2000 mg/kg No signs of systemic toxicity at the dose level of 300 mg/kg

Gross pathology:

Dark liver and dark kidneys at dose level of 2000 mg/kg

No abnormalities were noted at the dose level of 300mg/kg

Other findings:

not specified

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

The acute oral median lethal dose (LD50) of the test item was estimated to be in the range or 300-2000mg/kg body weight (GHS- category 4)