Propylidynetrimethanol, ethoxylated

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study was conducted in accordance to GLP and OECD guidelines.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2007

Report date:

2007

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1100 (Acute Oral Toxicity)

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Propylidynetrimethanol, ethoxylated

EC Number:

500-110-3

EC Name:

Propylidynetrimethanol, ethoxylated

Cas Number:

50586-59-9

Molecular formula:

C3H5(CH2O(C2H4O)nH) sum of n: >1 - <6.5 mol EO

IUPAC Name:

Propylidynetrimethanol, ethoxylated

Details on test material:

- Name of test material (as cited in study report): Lupranol 3903
- Stability under test conditions: analytically determined

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: RCC Ltd Laboratory, Füllinsdorf, Switzerland
- Age at study initiation: 8 - 12 weeks
- Weight at study initiation: 185 - 187g
- Housing: single housing
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

the stability of the test substance preparation was analytically verified

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

two groups of 3 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: clinical signs and mortality rates were determined several times on the day of administration and subsequently at least once each workday for the observation period; weight gain was checked before administration (day 0), weekly thereafter and at the end of the study
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

None

Clinical signs:

other: Clinical observation revealed impaired general state, dyspnooea and piloerection and were observed from hour 2 through to hour 5 after administration.

Gross pathology:

No abnormalities were noted at necropsy

Applicant's summary and conclusion

Conclusions:

The acute oral median lethal dose (LD50) of the test material in the female Wistar rat was > 2000 mg/kg bw with regard to a study according to OECD TG 423. A dose of 2000 mg/kg bw was tolerated without mortalities, effects on weight gain and gross pathological findings. Clinical observation revealed impaired general state, dyspnooea and piloerection and were observed from hour 2 through to hour 5 after administration.