Alcohols, C10-16, ethoxylated, sulfosuccinates, disodium salts

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

March 24, 2004 - May 10, 2004

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

Substance was tested as dissolved fraction only.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2004

Report date:

2004

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

2001

Deviations:

no

GLP compliance:

not specified

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Alcohols, C10-16, ethoxylated, sulfosuccinates, disodium salts

EC Number:

500-232-7

EC Name:

Alcohols, C10-16, ethoxylated, sulfosuccinates, disodium salts

Cas Number:

68815-56-5

Molecular formula:

not applicable to UVCB

IUPAC Name:

Alcohols, C10-16, ethoxylated, sulfosuccinates, disodium salts

Test animals

Species:

mouse

Strain:

ICR

Remarks:

Crl: WI (Han)

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Japan SLC, Inc.
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 4 weeks
- Fasting period before study: 4 hours fasting prior to the admnistration
- Housing: Five test animals each were housed in a polycarbonate cage and bred in a breeding room.
- Diet: ad libitum
- Water: tap water, ad libitum
- Acclimation period: approximately 2 weeks

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23 ± 2
- Photoperiod (hrs dark / hrs light): 12 /12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: 0.5 w/v% hydroxypropyl methyl cellulose

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 100 mg/mL
- Amount of vehicle: 20 mL/kg

MAXIMUM DOSE VOLUME APPLIED: 20 mL/kg

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5 females per group

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: before administration, and 7 and 14 days after administration
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, necropsies

Statistics:

none

Results and discussion

Effect levels

Effect levels 1

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat. (dissolved fraction)

Remarks:

27% solution

Effect levels 2

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 540 mg/kg bw

Based on:

act. ingr.

Mortality:

No deaths were found during the observation period.

Clinical signs:

other: In the sample group, diarrhea was observed in 2 animals approximately 4 hours after administration, which was resolved by Day 1 after administration with no other abnormalities reported subsequently. In the other animals, no abnormalities were found durin

Gross pathology:

No abnormalities identified in any of the test animals.

Any other information on results incl. tables

Table-1      Body weight change

Group	Before administration	After administration (day)
		7	14
Sample group	26.5±1.4 (5)	28.9±1.3 (5)	31.0±2.1 (5)
Control groups	26.3±1.0 (5)	28.7±0.9 (5)	31.2±0.7 (5)

Applicant's summary and conclusion

Interpretation of results:

study cannot be used for classification

Conclusions:

The acute oral LD50 of the test substance in female mice is >2000 mg/kg bw. As the test substance was a 27% solution of registration substance, the recalucated acute oral LD50 of the test substance in female mice is > 540 mg/kg bw.

Executive summary:

The acute oral LD50 for the test substance was determined in an OECD Guideline 420 test. Two groups, each of five female mice were successively dosed with 2000 mg/kg of test substance in 0.5 w/v% hydroxypropyl methyl cellulose (HPMC) and the solvent control (0.5 w/v% HPMC). All animals surrvived until the end of the study. The acute oral LD50 of the test substance in female mice is > 2000 mg/kg bw. As the test substance was a 27% solution of registration substance, the recalucated acute oral LD50 of the test substance in female mice is > 540 mg/kg bw.