Poly(oxy-1,2-ethanediyl), .alpha.-sulfo-.omega.-hydroxy-, C8-10-alkyl ethers, sodium salts

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

29 Aug - 19 Sep 2012

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2012

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Version / remarks:

adopted in 2001

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

Bayerisches Landesamt für Gesundheit und Lebensmittelsicherheit

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Alcohols, C8-10, ethoxylated, sulfates, sodium salts

EC Number:

939-523-2

Cas Number:

1471312-55-6

Molecular formula:

not available

IUPAC Name:

Alcohols, C8-10, ethoxylated, sulfates, sodium salts

Test material form:

semi-solid (amorphous): gel

Remarks:

paste

Test animals

Species:

rat

Strain:

other: WISTAR rats Crl: WI(Han)

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River, 97633 Sulzfeld, Germany
- Age at study initiation: 8-9 weeks
- Weight at study initiation: Step 1 (animals 1-3): 159 - 166 g; Step 2 (animals 4-6): 152 - 155 g
- Fasting period before study: Food was withheld from the test animals for 16 to 19 hours prior to the administration.
- Diet (ad libitum): Altromin 1324 maintenance diet for rats and mice (lot no. 0856)
- Water (ad libitum): tap water, sulphur acidified to a pH value of approximately 2.8
- Acclimation period: at least five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 55 ± 10
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 200g/L

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg

Doses:

2000 mg/kg

No. of animals per sex per dose:

3 females per step

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: A careful clinical examination was made several times on the day of dosing. Thereafter, the animals were observed for clinical signs once daily. The animals were weighed on day 1 (prior to the application) and on days 8 and 15.
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occured.

Clinical signs:

other: Clinical signs within the first 3 days after application comprised among others of piloerection, half eyelid-closure, tremor, reduced spontaneous activity, catalepsis and kyphosis. No clinical signs were observed thereafter.

Body weight:

lower than 10% body weight loss

Remarks:

Body weight gain was unaffected by treatment.

Gross pathology:

No findings upon necropsy.

Applicant's summary and conclusion

Interpretation of results:

other: CLP criteria not met, no classification required according to Regulation (EC) No 1272/2008

Conclusions:

The present experiment was conducted according to OECD test guideline 423 and compliant with GLP. Under the conditions of the study, the acute oral median lethal dose (LD50) of the test substance was found to be > 2000 mg/kg bw. Due to the experimental set-up, this result can be interpreted either a sAcute Toxicity Category 5 (GHS 2017), or unclassified (Regulation (EC) No. 1272/2008).