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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2017
Report date:
2017

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
GLP compliance:
yes
Remarks:
This study was conducted in accordance with the Good Laboratory Practices regulations of the EPA, 40 CFR Part 160 and 792, the FDA, 21 CFR Part 58, and OECD, Principles on Good Laboratory Practice, revised 1997.
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
1,1'-[(3-{bis[3-(dimethylamino)propyl]amino}propyl)imino]dipropan-2-ol
EC Number:
816-324-8
Cas Number:
2044770-20-7
Molecular formula:
C19H44N4O2
IUPAC Name:
1,1'-[(3-{bis[3-(dimethylamino)propyl]amino}propyl)imino]dipropan-2-ol
Test material form:
liquid
Details on test material:
Storage conditions: room temperature

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
Animals were received from Charles River, Raleigh NC, and Stone Ridge NY, on 11 Jul 2017. Following an acclimation period of at least five days, three male and three healthy, non-pregnant and nulliparous female Sprague Dawley rats were assigned to treatment groups without conscious bias.
The animals were born on 15 May 2017 and 22 May 2017. The pretest body weight range was 273 - 305 grams for males and 173 - 182 grams for females. The weight variation of the animals used did not exceed ±20% of the mean body weight of the previously dosed animals within a sex.
The animals were identified by cage notation and indelible body marks, and housed in suspended wire cages; five per sex per cage prior to dosing and three per sex per cage following dosing. Absorbent paper bedding was placed beneath the cages and changed at least three times per week. Fresh PMI Rat Chow (Diet No. 5012) was freely available except for 16-20 hours prior to dosing. Water was available ad libitum. The animal room, reserved exclusively for rats on acute tests, was temperature controlled, had a 12-hour light/dark cycle, and was kept clean and vermin free.

Administration / exposure

Route of administration:
oral: feed
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
The test article was used as received and the dose was based on the sample weight as calculated from the specific gravity. A single dose was administered orally by syringe and dosing needle at a dose level of 2000 mg/kg to three female rats and three male rats.
Doses:
A single dose was administered orally by syringe and dosing needle at a dose level of 2000 mg/kg to three female rats and three male rats.
No. of animals per sex per dose:
three female rats and three male rats
Control animals:
no
Details on study design:

Initially, three healthy female Sprague Dawley rats were dosed orally with Dabco NE1550 Catalyst Lot#20160225 at 2000 mg/kg. In addition, three healthy males were dosed as a confirmatory group at 2000 mg/kg. The rats were observed at 15 minutes, 1, 2 and 4 hours post-dose 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.

In Vivo - Animals were observed at 15 minutes, 1, 2 and 4 hours post-dose 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.
Post Mortem – All animals were humanely sacrificed using CO2 and were examined for gross pathology following study termination.

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
Three female and three male rats survived following a single oral dose of 2000 mg/kg.
Clinical signs:
Abnormal physical signs including hair loss (hip areas) and piloerection were observed.
Body weight:
All six animals gained body weight by study termination.
Gross pathology:
The gross necropsy revealed no observable abnormalities in three out of six animals. Localized hair loss was observed among two animals and a mottled kidney was observed in one animal.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Three female and three male rats survived following a single oral dose of 2000 mg/kg.
Abnormal physical signs including hair loss (hip areas) and piloerection were observed.
All six animals gained body weight by study termination.
The gross necropsy revealed no observable abnormalities in three out of six animals. Localized
hair loss was observed among two animals and a mottled kidney was observed in one animal.

The oral LD50 of Dabco NE1550 Catalyst is greater than 2000 mg/kg of body weight in rats and
is not classified according to GHS.
Executive summary:

Three female and three male rats survived following a single oral dose of 2000 mg/kg.

Abnormal physical signs including hair loss (hip areas) and piloerection were observed.

All six animals gained body weight by study termination.

The gross necropsy revealed no observable abnormalities in three out of six animals. Localized

hair loss was observed among two animals and a mottled kidney was observed in one animal.

Not classified since no mortality or significant clinical signs observed at 2000 mg/kg

The oral LD50 of Dabco NE1550 Catalyst is greater than 2000 mg/kg of body weight in rats and

is not classified according to GHS.

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