Coconut oil, reaction products with polyethylene glycol and trimethylolpropane

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1997-07-04 until 1997-06-25

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1997

Report date:

1997

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Reaction products of coconut oil with polyethyleneglycol and 2-ethyl-2-(hydroxymethyl)propane-1,3-diol

EC Number:

640-964-5

Cas Number:

218451-68-4

Molecular formula:

not applicable because UVCB

IUPAC Name:

Reaction products of coconut oil with polyethyleneglycol and 2-ethyl-2-(hydroxymethyl)propane-1,3-diol

Details on test material:

- Name of test material (as cited in study report): reaction product of polyethylen glycol and coconut oil
- Physical state: liquid
- Analytical purity: not mentioned
- Impurities (identity and concentrations): not mentioned
- Stability under test conditions: > 1 year
- Storage condition of test material: in closed containers under exhaust hood

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Winkelmann, Borchen, Germany
- Age at study initiation: young adult
- Weight at study initiation: weight male = 143 - 145 g; female = 137 - 143 g
- Fasting period before study: approximately 16 hours
- Housing: max. 5 animals in Makrolon type III cages, group-caged by sex
- Diet (e.g. ad libitum): Ssniff R10 diet in pelletform (laboratory standard rat diet) ad libitum, supplied by Ssniff Spezialfutter GmbH, Soest, Germany
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30 - 70 %
- Air changes (per hr): not mentioned
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 2.11 cm³ /kg bw

Doses:

2000 mg/kg bw

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: Examination of clinical signs up to 6 hours after the treatment and daily, individual bodyweights were recorded on day 0, 7 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: at least twice daily for any mortalities, macroscopical examinations of different tissues after killing

Statistics:

no

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

none animals died

Clinical signs:

other: no signs of systemic reaction to treatment

Gross pathology:

no abnormalities were observed

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

In the study performed the dosis letalis media (LD50) to rats of Coconut oil, reaction products with polyethylene glycol and trimethylolpropane was found to be > 2000 mg/kg bodyweight.

Executive summary:

In the study performed the dosis letalis media (LD50) to rats of Coconut oil, reaction products with polyethylene glycol and trimethylolpropane was found to be > 2000 mg/kg bodyweight.