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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
Study period:
2014
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2014
Report Date:
2014

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid
Details on test material:
-Physical state: liquid
- Analytical purity: on sponsor responsability
- Lot/batch No.: P_F54 and P_ MAGGIO 2013
- Expiration date of the lot/batch: 2014-11-30
- Stability under test conditions: on sponsor responsability
- Storage condition of test material: room temperature
Specific details on test material used for the study:
Purity > 97%

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Italy s.r.l, San Pietro al Natisone (UD) Italy
- Age at study initiation: 7 weeks old
- Weight at study initiation: 157-163 grams
- Fasting period before study: food was removed from the cage overnight prior to dosing
- Housing:Polisulphone solid bottomed cage measuring 59,5x38x20 cm with nesting material provided into suitable bedding bags
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C +- 2°C
- Humidity (%): 55% +- 15%
- Air changes (per hr): 15 to 20/ hour
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 200mg/mL
MAXIMUM DOSE VOLUME APPLIED: 10mL/kg
Doses:
2000 mg/kg
No. of animals per sex per dose:
3
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 2x/day
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
no mortality occured
Clinical signs:
no clinical signs were observed in the 2 groups of animals initially dosed at 2000mg/kg
Body weight:
body weight observed during the study were within the expected range for this strain and age of animals

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Acute toxicity for Trimethylolpropane Tripelargonate is expected to be greater than 2000 mg/kg body weight.
Executive summary:

The acute toxicity of Trimethylolpropane Tripelargonate was investigated following a single oral administration to the Sprague Dawley rat followed by a 14-day observation period. A first group of 3 female animals was initially dosed at 2000 mg/kg (Step 1). No mortality occurred and no clinical signs were observed. A second group of 3 female animals was then dosed at the same dose level (Step 2). No death occurred and no clinical signs were noted. Body weight changes recorded during the study were within the expected range for this strain and age of animals. No abnormalities were observed at necropsy examination performed at the end of the observation period on animals of both groups. These results indicate that the test item Trimethylolpropane Tripelargonate did not induce toxic effects in the rat following oral administration of a single dose at a level of 2000 mg/kg. The lack of mortality demonstrates the acute toxicity expected (ATE) to be greater than 2000 mg/kg body weight. European Directives concerning the classification, packaging and labelling of dangerous substances (Council Regulation (EC) No. 1272/2008 and subsequent revisions) would indicate the following:

- Classification: not required

- Signal word: not required

- Labeling: not required