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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:
weight of evidence
Study period:
2002
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:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
GLP compliance:
yes (incl. certificate)
Test type:
acute toxic class method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
Propylidenetrimethanol, propoxylated mw 310; clear, colourless, viscous liquid; purity not reported

Test animals

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


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

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
Gavage administration
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 th day
- Necropsy of survivors performed: yes
Statistics:
Not required

Results and discussion

Preliminary study:
Not reported
Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 500 mg/kg bw
Based on:
test mat.
Mortality:
None
Clinical signs:
On the day of dosing and up to 24 hours after dosing: hunched posture, lethargy, ataxia, decreased respiratory rate, ptosis, occasional body tremors, laboured respiration, exophthalmos and pilo-erection. All animals appeared normal two days after dosing.
Body weight:
All animals showed expected gains in bodyweight over the study period.
Gross pathology:
No abnormalities were noted at necropsy

Any other information on results incl. tables

On the day of dosing and up to 24 hours  after dosing: hunched posture, lethargy, ataxia, decreased  respiratory rate, ptosis, occasional body tremors,  laboured respiration, exophthalmos and pilo-erection. All  animals appeared normal two days after dosing.

Applicant's summary and conclusion

Interpretation of results:
Category 5 based on GHS criteria
Conclusions:
The acute oral median lethal dose (LD50) of the test material in the female Sprague-Dawley CD strain rat was estimated from the flow chart in Appendix 1 (OECD 423) as being greater than 2500 mg/kg bodyweight. No classification is required according to CLP criteria.
Executive summary:

The acute oral toxicity of (propylidenetrimethanol, propoxylated mw 310) in the rat was found to be >2000 mg/kg bw (OECD 423). No deaths occurred in the study following the administration of a single dose of 2000 mg/kg bw. On the day of dosing and up to 24 hours  after dosing: hunched posture, lethargy, ataxia, decreased  respiratory rate, ptosis, occasional body tremors,  laboured respiration, exophthalmos and pilo-erection. All  animals appeared normal two days after dosing. All animals showed expected gains in bodyweight over the study period. No abnormalities were noted at necropsy.