Fatty acids, C16-18 and C18-unsatd., reaction products with glycidyl neodecanoate and 7-oxabicyclo[4.1.0]hept-3-ylmethyl 7-oxabicyclo[4.1.0]heptane-3-carboxylate

Acute Toxicity: oral

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

Justification for type of information:

Guideline study under GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2016

Report date:

2016

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)

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

{3-hydroxy-4-[(9Z)-octadec-9-enoyloxy]cyclohexyl}methyl 3-hydroxy-4-[(9Z,12Z)-octadeca-9,12-dienoyloxy]cyclohexane-1-carboxylate; {3-hydroxy-4-[(9Z,12Z)-octadeca-9,12-dienoyloxy]cyclohexyl}methyl 3-hydroxy-4-[(9Z,12Z)-octadeca-9,12-dienoyloxy]cyclohexane-1-carboxylate

EC Number:

917-830-2

Cas Number:

1186514-91-9

Molecular formula:

not available for UVCB substances

IUPAC Name:

{3-hydroxy-4-[(9Z)-octadec-9-enoyloxy]cyclohexyl}methyl 3-hydroxy-4-[(9Z,12Z)-octadeca-9,12-dienoyloxy]cyclohexane-1-carboxylate; {3-hydroxy-4-[(9Z,12Z)-octadeca-9,12-dienoyloxy]cyclohexyl}methyl 3-hydroxy-4-[(9Z,12Z)-octadeca-9,12-dienoyloxy]cyclohexane-1-carboxylate

Test material form:

liquid

Details on test material:

Lot # 210164, brown liquid, homogeneous, Expiry date: 2017-12-16

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Velaz Province, Czech Republic
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 180-200 g
- Fasting period before study: Overnight
- Housing: plastic cages, 3 animals/cage, bedding: Lignocel S3/4
- Diet (e.g. ad libitum): ad lib, altromin
- Water (e.g. ad libitum): ad lib, tap water (certificate of analysis available)
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2 ˚C
- Humidity (%): 55 +/- 10
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 2016/03/10 To: 2016/03/30

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

olive oil

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

6

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Immediately after administration, 0.5, 1.0, 2, and 4.0 hours after administration. Further observed once daily for 14 days.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: observations included changes in skin and fur, eyes and mucous membranes, and also respiratory, circulatory, autonomic and central nervous system, and somatomotor activity and behaviour patterns. Attention was directed to observations of tremors, convulsions, salivation, diarrhoea, lethargy, sleep, and coma.

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

There was no mortality during 14 day study period

Clinical signs:

other: There were no observed clinical signs

Gross pathology:

No gross pathology was observed during 14 day study period

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The acute oral LD50 of the test material is > 2000 mg/kg bw in the Wistar rat.