oils, palm, propoxylated

Endpoint summary

Description of key information

In a reliable 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.

In a reliable acute oral toxicity study a structurally similar substance was administered to Sprague Dawley rats (6 animals) by oral gavage at a dose level of 2000 mg/kg bw (single administration). The oral LD50 is >2500 mg/kg bw.

In a reliable acute dermal toxicity study a structurally similar substance was administered to Sprague Dawley rats (5 animals/sex) by semi-occluded dermal application for 24 hours at a dose level of 2000 mg/kg bw (single administration). The dermal LD50 is >2000 mg/kg bw.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Reference 1

Endpoint:

acute toxicity: oral

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

Read-across to K1 study therefore K2 is the maximum Klimisch value.

Justification for type of information:

Read-across approach - see read-across justification in section 13.

Reason / purpose for cross-reference:

read-across source

GLP compliance:

yes

Test type:

acute toxic class method

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Route of administration:

oral: gavage

Vehicle:

water

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

6 animals

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 500 mg/kg bw

Based on:

test mat.

Mortality:

No deaths

Clinical signs:

other: No signs of systemic toxicity

Gross pathology:

No abnormalities were noted at necropsy

Interpretation of results:

GHS criteria not met

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The oral LD50 for the substance was > 2500 mg/kg (2000 mg/kg).

Executive summary:

In an acute toxicity study the substance was administered to Sprague Dawley rats (6 animals) 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 comparable with the control animals and no abnormalities found at macroscopic post-mortem examination. The LD50 is >2500 mg/kg bw as concluded by the study facilitator.

Reference 2

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

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.

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

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

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.

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

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.

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.

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Quality of whole database:

Sufficient to address requirements.

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Quality of whole database:

Sufficient to address requirements.

Justification for classification or non-classification

Based on the findings of a reliable studies conducted on the substance and a structural analogue, classification of the substance is not justified.