Registration Dossier

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:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report date:
2002

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
GLP compliance:
yes (incl. QA statement)
Remarks:
The Department of Health of the Government of the United Kingdom, GLP Monitoring Authority, UK
Test type:
acute toxic class method

Test material

Constituent 1
Chemical structure
Reference substance name:
Propylidynetrimethanol, propoxylated
EC Number:
500-041-9
EC Name:
Propylidynetrimethanol, propoxylated
Cas Number:
25723-16-4
Molecular formula:
C3H5(CH2OR)3 R= (C2H3(CH3)O)nH sum of n: >1 - <6.5 mol PO
IUPAC Name:
Propylidynetrimethanol, propoxylated
Details on test material:
Propylidenetrimethanol, propoxylated mw 310; clear,
colourless, viscous liquid; purity not reported

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Bantin & Kingman, Hull, UK
- Age at study initiation: 8 - 12 weeks
- Weight at study initiation: 169 - 186 g
- Housing: Groups of 3 in suspended solid floor polypropylene cages with woodflakes
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25
- Humidity (%): 30 - 70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
6
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 7 and 14 day
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
None
Clinical signs:
On the day of dosing and up to 24 h after dosing: hunched posture, lethargy, ataxia, decreased respiratory rate, ptosis, occasional body tremors, laboured respiration, exophthalmos and piloerection. All animals appeared normal two days after dosing.
Body weight:
All animals showed expected gains in body weight over the study period.
Gross pathology:
No abnormalities were noted at necropsy.

Any other information on results incl. tables

Additional data supporting the information is attached below under 'Attached background material'.

Applicant's summary and conclusion

Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008.
Conclusions:
The acute oral LD50 in the female Sprague-Dawley CD strain rat was determined to be > 2000 mg/kg bw.