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

Endpoint summary

Description of key information

Acute toxicity, oral (rat): 300 mg/kg bodyweight < LD50 < 2000 mg/kg bodyweight

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:

06 September 2017 - 02 Ocober 2017

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

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

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

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

Preliminary study:

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

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

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)

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

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

An acute oral toxicity study was conducted (Envigo Research Limited, 2017, Study KM39QF) to assess the toxicity of Sulfonic acids, C14-18-alkane hydroxy and C12-20-alkapolyene and C14-18-alkene and C12-20-alkene hydroxy, sodium salts following a single oral administration. The study was conducted in accordance with OECD and EC test guidelines, and in compliance with GLP.

In accordance with the acute toxic class method, one fasted female rat was administered a single dose of 2000 mg/kg and one fasted female rat was administered a single dose of 300 mg/kg Sulfonic acids, C14-18-alkane hydroxy and C12-20-alkapolyene and C14-18-alkene and C12-20-alkene hydroxy, sodium salts by oral gavage.

As the rats at the 2000 mg/kg dose level died, a further four female rats were dosed at 300 mg/kg. No rats in the group died at 300 mg/kg.

It was concluded that the acute median lethal dose in rats following oral administration of Sulfonic acids, C14-18-alkane hydroxy and C12-20-alkapolyene and C14-18-alkene and C12-20-alkene hydroxy, sodium salts was between 300 mg/kg and 2000 mg/kg.

No acute dermal toxicity and acute inhalation toxicity study was conducted.

Justification for classification or non-classification

The oral LD50 was found to fall in the range 300 mg/kg to 2000 mg/kg. In accordance with the Regulation (EC) 1272/2008 Appendix 1 (table 3.1.1) the substance will be classified as acute toxicity category 4 by the oral route. The applicable hazard phrase is "H302: Harmful if swallowed".

No data are available for the acute toxicity hazard by the dermal or inhaled routes.

No sub-lethal effects were observed in the organs of Rats receiving the 300 mg/kg dose in the above Acute Oral Toxicity study. It is considered that there is no basis to apply a classification for Specific Target Organ Toxicity following a Single Exposure (STOT-SE).