oils, palm, propoxylated

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

12 February 2018 - 05 March 2018

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:

2018

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)

Version / remarks:

2001

Deviations:

yes

Remarks:

Due to a technician error, the Day 14 body weight for the initial animal treated at a dose level of 2000 mg/kg was not recorded. This deviation was considered not to affect the purpose or integrity of the study.

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)

GLP compliance:

yes

Test type:

fixed dose procedure

Limit test:

no

Test material

Test material information

1

Reference substance name:

oils, palm, propoxylated

EC Number:

610-641-3

Cas Number:

512802-65-2

Molecular formula:

UVCB

IUPAC Name:

oils, palm, propoxylated

Specific details on test material used for the study:

Batch: 1023R26015
Purity: 99.7%
Physical state / Appearance: Yellow liquid
Expiry Date: 16 March 2018
Storage Conditions: room temperature in the dark

Test animals

Species:

rat

Strain:

Wistar

Remarks:

ccHan™:WIST

Sex:

female

Details on test animals or test system and environmental conditions:

The females were nulliparous and non-pregnant. After an acclimatization period of at least 5 days the animals were selected at random and given a number unique within the study by indelible ink-marking on the tail and a number written on a cage card. At the start of the study the animals were 8 to 12 weeks of age. The body weight variation did not exceed ± 20% of the mean body weight of any previously treated animals.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Doses:

Sighting test at 300 mg/kg bw.
Main test at 2000 mg/kg bw.

No. of animals per sex per dose:

Sighting test at 300 mg/kg bw - 1 animal
Main test at 2000 mg/kg bw - 5 animals

Control animals:

no

Results and discussion

Preliminary study:

At a dose level of 300 mg/kg bw there was no mortality, no signs of systemic toxicity were noted, the animal showed an expected gain in body weight over the observation period and no abnormalities were noted at necropsy.

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

There were no deaths.

Clinical signs:

other: No signs of systemic toxicity were noted during the observation period.

Gross pathology:

No abnormalities were noted at necropsy.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The oral LD50 is >2000 mg/kg bw.

Executive summary:

In an acute oral toxicity study the substance was administered to Wistar rats (5 animals/sex/dose) by oral gavage at a dose level of 2000 mg/kg bw (single administration). There were no mortalities or signs of clinical toxicity, mean body weight gain was as expected and no abnormalities found at macroscopic post-mortem examination. The oral LD50 is >2000 mg/kg bw.