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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
03 Aug 2016 - 30 Sep 2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
Acute Toxic Class Determination (Oral) in Rats

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2016
Report Date:
2016

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
not specified
Qualifier:
according to
Guideline:
EPA OPPTS 870.1100 (Acute Oral Toxicity)
Deviations:
not specified
Principles of method if other than guideline:
Initially, three healthy female Sprague Dawley rats were dosed orally with Solvent-free Dabco TMR-2 Batch# chernil.20160628.B 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-dosing 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.
GLP compliance:
yes (incl. certificate)
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid: viscous
Specific details on test material used for the study:
Identity : Solvent-free Dabco TMR-2 Batch# chernil.20160628.B
Test Article
Characterization : See Appendix A for Test Article Characterization.
Supplied by : Air Products and Chemicals, Inc.
Date Received : 18 Jul 2016
Storage : Room temperature and humidity
Description : Clear colorless liquid
Specific Gravity : 1.14
Sample Preparation : Used as received

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
Animals were received from Charles River, Raleigh NC and Stone Ridge NY, on 26 Jul 2016 and 09 Aug 2016.
The pretest body weight range was 231 - 254 grams for males and 192 - 207 grams for females.

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 #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: gavage
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:
All animals dosed at 2000 mg/kg
No. of animals per sex per dose:
3
Control animals:
no
Details on study design:
In Vivo - Animals were observed at 15 minutes, 1, 2 and 4 hours post-dosing 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

Preliminary study:
N/A
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
2 000 mg/kg bw
Based on:
test mat.
Mortality:
All three female and three male rats survived following a single 2000 mg/kg oral dose.
Clinical signs:
No abnormal physical signs were observed among four out of six animals. One female had chromorhinorrhea on Day 11 and one male had diarrhea and soiling of the anogenital area on Day 0.
Body weight:
All six animals gained body weight by study termination.
Gross pathology:
The gross necropsy revealed no observable abnormalities.
Other findings:
No abnormal physical signs were observed among four out of six animals. One female had chromorhinorrhea on Day 11 and one male had diarrhea and soiling of the anogenital area on Day 0.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The oral LD50 of Solvent-free Dabco TMR-2 is greater than 2000 mg/kg of body weight in rats.
GHS: Not classified
Executive summary:

Three healthy female Sprague Dawley rats were dosed orally with Solventfree Dabco TMR-2 Batch# chernil.20160628.B 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-dosing 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.

All three female and three male rats survived following a single 2000 mg/kg oral dose. No abnormal physical signs were observed among four out of six animals. One female had chromorhinorrhea on Day 11 and one male had diarrhea and soiling of the anogenital area on Day 0. All six animals gained body weight by study termination. The gross necropsy revealed no observable abnormalities.