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Diss Factsheets

Administrative data

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

Data source

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

Materials and methods

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

Test material

Constituent 1
Chemical structure
Reference substance name:
1,2-Ethanediamine, N-(2-aminoethyl)-, reaction products with glycidyl tolyl ether
EC Number:
282-199-6
EC Name:
1,2-Ethanediamine, N-(2-aminoethyl)-, reaction products with glycidyl tolyl ether
Cas Number:
84144-79-6
Molecular formula:
C14H26N3O2
IUPAC Name:
1,2-Ethanediamine, N-(2-aminoethyl)-, reaction products with glycidyl tolyl ether
Test material form:
liquid: viscous
Specific details on test material used for the study:
Manufacturer - Air Products
Batch - 8418406

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, Stone Ridge NY, on 29 Mar 2016 and 05 Apr 2016. Following
an acclimation period of at least five days, three male and nine healthy, non-pregnant and nulliparous
female Sprague Dawley rats were assigned to treatment groups without conscious bias.
The animals were born on 01 Feb 2016 and 15 Feb 2016. The pretest body weight range was
222 - 242 grams for males and 180 - 197 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 #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)
Doses:
Dose Level mg/kg #Animals/Sex
2000 3/F
1000 3/F
300 3/F
*300 3/M
*Confirmatory group
No. of animals per sex per dose:
Dose Level mg/kg #Animals/Sex
2000 3/F
1000 3/F
300 3/F
*300 3/M
Control animals:
yes

Results and discussion

Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 300 - < 1 000 mg/kg bw
Based on:
test mat.
Mortality:
Dose Level mg/kg #Animals/Sex Response(O=Survived, X=Died)
2000 3/F 3/X
1000 3/F 3/X
300 3/F 3/O
*300 3/M 3/O
*Confirmatory group
Clinical signs:
other: 2000 mg/kg dose Three female rats died, by Day 2, following a single 2000 mg/kg oral dose. Prior to death, abnormal physical signs including chromorhinorrhea, lethargy, ataxia, and wetness and soiling of the anogenital area were observed. Terminal body we
Gross pathology:
See information summarized in clinical signs section

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
Acute toxicity of 1,2-Ethanediamine, N-(2-aminoethyl)-, reaction products with glycidyl tolyl ether to rats was evaluated using OECD 423 method. Study determined value of LD50 to be in interval 300 mg/kg b.w. - 1000 mg/kg b.w.
Executive summary:

Acute toxicity of 1,2-Ethanediamine, N-(2-aminoethyl)-, reaction products with glycidyl tolyl ether to rats was evaluated using OECD 423 method. Study determined value of LD50 to be in interval 300 mg/kg b.w. - 1000 mg/kg b.w.