1-O-β-(2 ,3-di-O-alka(e)noyl-6 -O-acetyl-D-mannopyranosyl)-D-erythritol

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

26 Feb - 05 April 2007

Reliability:

3 (not reliable)

Rationale for reliability incl. deficiencies:

significant methodological deficiencies

Remarks:

Non-GLP study conducted to a method similar to OECD 423 but with methodological deficiencies.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2019

Report date:

2019

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

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

Version / remarks:

2001

Deviations:

yes

Remarks:

only 7 days observations

GLP compliance:

no

Remarks:

The experiment was performed in 2007, therefore pre-dating 1st June 2008 cut off after which GLP compliance is necessary for toxicological tests. The report is dated 2019, because this is when the report itself was finalised.

Test type:

other: Method similar to acute toxicity classic

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Reference substance 001

Cas Number:

126482-45-2

Test material form:

liquid

Details on test material:

Storage of test material: in a tightly sealed container, under refrigeration
Informal name: MEL-2

Test animals

Species:

rat

Strain:

other: Slc:Wistar [SPF]

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Japan SLC , Inc.
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 5-6 weeks
- Weight at study initiation: 103 - 107 g
- Fasting period before study: yes (17 hour)
- Housing: Animals were individually housed in wire mesh cage, 19.7W×26.3D×18.0H (cm), One animal/cage (during the study).
- Diet (e.g. ad libitum): CRF-1
(Oriental Yeast, Lot No. 061108) sterilized by irradiated ad libitum (except when fasted).
- Water (e.g. ad libitum): tap water from automated water supply system ad libitum. 

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.0−26.0°C
- Humidity (%): 35.0−75.0%
- Air changes (per hr): 12 or more times air changes per hour
- Photoperiod (hrs dark / hrs light): 12 : 12
IN-LIFE DATES: 26/2/ 2007 – 15/3/2007

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

The test item was administered to animals fasted for 17 hrs by a single gavage using a stomach tube. The dose volume was 0.5 mL per 100g body weight and the individual volume was calculated from each body weight value obtained before the administration.

Doses:

2000 mg/kg

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

A dose of 2,000 mg/kg was administered to three females, this is followed by observation within 30 minutes, once each at 1, 2, 3, 4, 5 & 6 hours after dosing. From the next day after dosing (from day 1 – 7), the animals were observed once daily.

Statistics:

No statistical analysis was conducted

Results and discussion

Preliminary study:

No preliminary study conducted.

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

>= 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: No adverse effects observed

Mortality:

No deaths reported

Clinical signs:

other: No effects observed

Gross pathology:

No grossly visible abnormalities were observed in any animal at 2,000 mg/kg.

Other findings:

None

Any other information on results incl. tables

Table 2. Results and observations after dosing

Dose level (mg/kg) 2000	Animal I.D No.	Body weight (g) days after dosing		Anatomical Finding (days after dosing)	Mortality (days after dosing)	Clinical Observation (days after dosing)
		0*	7	7	7	7
	1	103	137	No abnormality observed	None observed	None observed
	2	105	136	No abnormality observed	None observed	None observed
	3	107	128	No abnormality observed	None observed	None observed

*Just before administration

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was estimated to be greater than 2000 mg/kg body weight (Globally Harmonized Classification System Unclassified).

Executive summary:

Methodology similar to OECD 423 (2001) - In an acute oral toxicity study, three group of female Wistar rats (5 -6 week old) were given a single oral dose of the test item using a gavage at dose rate of 2000 mg/kg bw followed by 7 days observation.

No mortality was noted during the observation period, no effects on body weight and no overt toxicological changes were noted. The oral LD50 was estimated to be greater than 2000 mg/kg bw.

In conclusion, the test item did not meet the criteria for classification according to Regulation (EC) No. 1272/2008 on the Classification, Labelling and Packaging of Substances and Mixtures.