Alcohols, C9-11, branched and linear, ethoxylated, sulfates, sodium salts

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

Refer to the Category Approach Justification document provided in IUCLID6 Section 13.

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:

(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:

Fatty alcohol ether sulfate, sodium salt, C8-10 2EO

IUPAC Name:

Fatty alcohol ether sulfate, sodium salt, C8-10 2EO

Test material form:

semi-solid (amorphous): gel

Remarks:

migrated information: 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

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: No mortality occurred.

Mortality:

No mortality occured.

Clinical signs:

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:

No effects on body weight observed.

Gross pathology:

No findings upon necropsy.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

CLP: not classified