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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:
2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Test material form:
liquid: viscous
Specific details on test material used for the study:
Identity Solvent-free Dabco TMR Batch# meyersl.20160601
Test Article See Appendix A for Test Article Characterization.
Characterization
Supplied by Air Products and Chemicals, Inc.
Date Received 18Jul2016
Storage Room temperature and humidity
Description Clear light-yellow viscous liquid
Specific Gravity 1.04
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, on 06 Sep 2016. Following an acclimation period of at least five days, healthy male and healthy, non-pregnant and nulliparous female Sprague Dawley rats were assigned to treatment groups without conscious bias.
The weight
variation of the animals used did not exceed ±20% of the mean body weight of the previously dosed animals within a sex.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
A single dose was administered orally by syringe and dosing needle.
Doses:
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 female rats and 2000 mg/kg male rats.
No. of animals per sex per dose:
3 male and 3 female rats
Control animals:
no
Details on study design:
Animals 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, at death and at termination.
Statistics:
N/A

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:
No mortality observed.
Clinical signs:
Not measured
Body weight:
All animals had gained body weight by study termination.
Gross pathology:
Gross necropsy revealed no observalbale abnormalities.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
All three female and three male rats survived following the 2000 mg/kg oral dose.
No abnormal physical signs were observed among all six animals.
The animals gained body weight by study termination and the gross necropsy revealed no observable abnormalities.

The oral LD50 of Solvent-free Dabco TMR Batch# meyersl.20160601 is greater than 2000 mg/kg of body weight in rats.