1,2-Ethanediamine, N-(2-aminoethyl)-, reaction products with glycidyl tolyl ether

Endpoint summary

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

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)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

no

Specific details on test material used for the study:

Manufacturer - Air Products
Batch - 8418406

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.

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

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

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.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Value:

300 mg/kg bw