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Toxicological information

Acute Toxicity: oral

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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 guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Qualifier:
according to guideline
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
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

Constituent 1
Chemical structure
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:
Clinical observation revealed impaired general state, dyspnooea and piloerection and were observed from hour 2 through to hour 5 after administration.
Body weight:
All animals showed expected gains in bodyweight over the study period.
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.