D-Glucitol, 1-deoxy-1-[methyl(1-oxononyl)amino]-

Endpoint summary

Description of key information

The test item was tested for its acute oral toxicity potential. In total six healthy female Sprague Dawley rats were dosed orally with the test item at 2000 mg/kg. The rats were observed at 15 minutes, 1, 2 and 4 hours postdose and once daily for 14 days for toxicity and pharmacological effects, and twice daily for mortality. All six female rats survived following the single 2000 mg/kg oral dose. No test item realated and toxicological relevant effects were observed after administration of the test item over the observation period of 14 days. The gross necropsy revealed no observable abnormalities. Based on these results the oral LD50 of the test item is greater than 2000 mg/kg of body weight in females rats.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

24-02-2017 to 19-07-2017

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

Adopted: 17th december 2001

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals or test system and environmental conditions:

Animal Requirements:
- Number of Animals : 6 animals
- No. Animals/Group : 3 - 6
4.1.4: Sex : Females (nulliparous and non-pregnant)
(Justification required for the use of males)
(Refer to Section 4.2.2 of this protocol)
- Species/ Strain : Rat/Sprague Dawley
- Age/Weight : 8 to 12 weeks / +/- 20% of mean weight of previously dosed animals within a sex


Husbandry:
- Housing: Animals will be housed in suspended wire cages which conform to the size recommendations in Guide for the Care and Use of Laboratory Animals DHEW (NIH). Rats will be housed 5 per sex per cage prior to dosing and 3 per sex per cage following dosing. Absorbent paper bedding, placed beneath the cage, will be changed at least three times per week. The animal room, reserved exclusively for rodents on acute tests, is temperature controlled, has a 12-hour light/dark cycle, and will be kept clean and vermin free.
- Acclimation: The test animals will be conditioned to the housing facilities for at least five days prior to testing.
- Food: Fresh PMI Rat Chow (Diet #5012) will be available except 16 - 20 hours prior to dosing.
- Water: Water will be available ad libitum.

Route of administration:

oral: gavage

Vehicle:

water

Doses:

2000 mg/kg BW

No. of animals per sex per dose:

3 females + 3 females

Control animals:

no

Details on study design:

Initially, three healthy female Sprague Dawley rats were dosed orally with MTDID 48740 the test item at 2000 mg/kg. In addition, three healthy females were dosed as a confirmatory group at 2000 mg/kg. The rats were observed at 15 minutes, 1, 2 and 4 hours postdose and once daily for 14 days for toxicity and pharmacological effects, and twice daily for mortality. Body weights were recorded immediately pretest, weekly and at termination. All animals were examined for gross
pathology. The test article was assigned to a toxic category based on the mortality response noted.

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

not determinable due to absence of adverse toxic effects

Mortality:

No mortality occurred until the end of observation period.

Clinical signs:

other: non-specific and sporadic physical signs including wetness on the nose/mouth area (n=3) directly after adminstration, wetness and yellow staining on the anogenital area (n=3, only at the first day after oral administration), chromorhinorrhea (n=3, in one

Gross pathology:

No abnormalities observed.

Interpretation of results:

GHS criteria not met

Conclusions:

LD 50> 2000 mg/kgBW

Executive summary:

The acute oral toxicity study of the test item was performed according to OECD Test Guideline 423.Initially, three healthy female Sprague Dawley rats were dosed orally with the test item at 2000 mg/kg. In addition, three healthy females were dosed as a confirmatory group at 2000 mg/kg. The rats were observed at 15 minutes, 1, 2 and 4 hours postdose and once daily for 14 days for toxicity and pharmacological effects, and twice daily for mortality. All six female rats survived following the single 2000 mg/kg oral dose. No test item realated and toxicological relevant effects were observed after administration of the test item over the observation period of 14 days. The gross necropsy revealed no observable abnormalities. Based on these results the oral LD50 of the test item is greater than 2000 mg/kg of body weight in females rats.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Quality of whole database:

reliable without restrictions (GLP-Study according to OECD 423)

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available