Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
24th March - 1st June 2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018
Report date:
2017

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.1100 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
up-and-down procedure
Limit test:
yes

Test material

Constituent 1
Reference substance name:
2,3-Epoxypropyl neodecanoate, oligomeric reaction products with cyclohexane-1,2-dicarboxylic anhydride and propylidenetrimethanol
EC Number:
500-334-1
EC Name:
2,3-Epoxypropyl neodecanoate, oligomeric reaction products with cyclohexane-1,2-dicarboxylic anhydride and propylidenetrimethanol
Cas Number:
154565-28-3
Molecular formula:
A molecular formaula is not available for this UVCB
IUPAC Name:
2,3-Epoxypropyl neodecanoate, oligomeric reaction products with cyclohexane-1,2-dicarboxylic anhydride and propylidenetrimethanol
Test material form:
solid
Remarks:
Clear yellow resin
Specific details on test material used for the study:
Epoxypropyl neodecanoate, oligomeric reaction products with cyclohexane-1,2-dicarboxylic anhydride and propylidenetrimethanol
Batch #CVR 83297
97.2% purity
Supplied by : PPG
Date Received : 23 Mar 2017
Storage : Room temperature and humidity
Description : Clear yellow viscous semi-solid
Specific Gravity : 1.21

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River
- Females: nulliparous and non-pregnant: yes
- Weight at study initiation: 186-223 g
- Housing: Individual
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): not reported (temperature controlled)
- Humidity (%): not reproted
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 28/03/2017 To: 26/04/2017

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
The test material was used as received and the dose was based on the sample weight as calculated from the specific gravity.
Doses:
Single gavage dose; 2000 mg/kg bw
No. of animals per sex per dose:
Initially, a single female Sprague Dawley rat was dosed orally at a dose level of 2000 mg/kg bw. Since the rat survived, four additional females were dosed at 2000 mg/kg bw.
Control animals:
no
Details on study design:
Rats were observed at 15 minutes, 1, 2 and 4 hours post-dosing and once daily thereafter for 14 days for toxicity and pharmacological effects. Observations included, but were not limited to: evaluation of skin and fur, eyes and mucous membranes, respiratory and circulatory effects, autonomic effects such as salivation, central nervous system effects including tremors and convulsions, changes in the level of activity, gait and posture, reactivity to handling or sensory stimuli, altered strength, and stereotypies or bizarre behaviour (e.g., self-mutilation, walking backwards). All rats were observed twice daily for mortality on Days 1-14. Body weights were recorded pre-test, weekly, and at termination.

All rats were humanely euthanised using CO2 following study termination and subjected to gross necropsy
Statistics:
Not required

Results and discussion

Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
All five female rats survived following a single 2000 mg/kg bw oral dose.
Clinical signs:
Localised hair loss was observed in one rat on Days 10-14, and wetness of the anogenital area was observed in one rat at 15 minutes post-dosing.
Body weight:
All five rats gained body weight by study termination.
Gross pathology:
Gross necropsy revealed localised hair loss in one rat.
Other findings:
No additional findings were noted

Any other information on results incl. tables

Summary of findings

Rats dosed (2000 mg/kg bw)

Mortality

Clinical signs

5 females

0/5

1/5

Applicant's summary and conclusion

Interpretation of results:
Category 5 based on GHS criteria
Conclusions:
No mortality occurred at a dose level of 2000 mg/kg bw. The test material [epoxypropyl neodecanoate, oligomeric reaction products with cyclohexane-1,2-dicarboxylic anhydride and propylidenetrimethanol] does not therefore require classification for acute oral toxicity according to the CLP Regulation.
Executive summary:

The acute oral toxicity of epoxypropyl neodecanoate, oligomeric reaction products with cyclohexane-1,2-dicarboxylic anhydride and propylidenetrimethanol was investigated in a study using the Up and Down procedure (OECD 425). Rats received a single gavage dose of the unchanged test material and were observed for 14 days. Rats were observed at 15 minutes, 1, 2 and 4 hours post-dosing and once daily thereafter for 14 days for toxicity and pharmacological effects. Bodyweights were recorded weekly. All rats were subject to gross necropsy. Initially, a single female Sprague Dawley rat was dosed orally at a dose level of 2000 mg/kg bw. Since this rat survived, four additional female rats were dosed at 2000 mg/kg bw. No deaths occurred in this group. Localised hair loss was observed in one rat on Days 10-14, and wetness of the anogenital area was observed in one rat at 15 minutes post-dosing. All five rats gained bodyweight by study termination. Gross necropsy revealed localised hair loss in one rat. No mortality occurred at a dose level of 2000 mg/kg bw.  The acute oral LD50 is therefore >2000 mg/kg bw. The test material [epoxypropyl neodecanoate, oligomeric reaction products with cyclohexane-1,2-dicarboxylic anhydride and propylidenetrimethanol] does not therefore require classification for acute oral toxicity according to the CLP Regulation.