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Administrative data

Description of key information

A modern, GLP- and guideline (OECD 425) compliant study of acute oral toxicity is available for the submission substance. Waivers are proposed for acute dermal toxicity (based on the very low acute oral toxicity) and for acute inhalation toxicity (based on the lack of exposure potential).

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
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
Qualifier:
according to
Guideline:
OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 870.1100 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
up-and-down procedure
Limit test:
yes
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
Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Details on test animals 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
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
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

Summary of findings

Rats dosed (2000 mg/kg bw)

Mortality

Clinical signs

5 females

0/5

1/5

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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw
Quality of whole database:
A modern, GLP- and guideline (OECD 425) compliant study of acute oral toxicity is available for the submission substance.

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

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 of epoxypropyl neodecanoate, oligomeric reaction products with cyclohexane-1,2-dicarboxylic anhydride and propylidenetrimethanol is therefore >2000 mg/kg bw.

Justification for classification or non-classification

Based on an acute oral LD50 of >2000 mg/kg bw, the submission substance [epoxypropyl neodecanoate, oligomeric reaction products with cyclohexane-1,2-dicarboxylic anhydride and propylidenetrimethanol] does not require classification for acute oral toxicity according to the CLP Regulation.