Registration Dossier

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:
other: 1a Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Ethylenediamine, propoxylated
EC Number:
500-035-6
EC Name:
Ethylenediamine, propoxylated
Cas Number:
25214-63-5
Molecular formula:
(C3H6O)n (C3H60)n (C3H6O)n(C3H6O)n C2H8N2 sum of n: >1 - 8.5
IUPAC Name:
Ethylenediamine, propoxylated
Details on test material:
Ethylenediamine, propoxylated
MW 280
clear, colourless, viscous liquid
purity not reported

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ORGANISMS: Wistar-rats (Hsd/Win:WU)
- Source: Harlan-Winkelmann GmbH, Borchen, Germany
- Age: 6 - 9 weeks
- Weight at study initiation: males 241 g, females 167 g

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: polyethylene glycol 400
Details on oral exposure:
ADMINISTRATION:
- Administration route: gavage, fasted animals
- Administrationvolume: 10 ml/kg bw
- Group size: 5 /dose/sex
- Post dose observation period: 14 days
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5 animals/dose/sex
Details on study design:
EXAMINATIONS: Any deaths and overt signs of toxicity were recorded repeated times on day of dosing and daily for 14 days. Bodyweights were recorded on the day of dosing and on days 7 and 14. At the end of the study all animals were subject to gross necropsy, macroscopic abnormalities were recorded, no tissues were retained.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
MORTALITY: No animals died.
Clinical signs:
CLINICAL SIGNS: There were no signs of systemic toxicity.
Body weight:
BODYWEIGHTS: All rats gained in bodyweight over the observation period.
Gross pathology:
NECROPSY FINDINGS: No findings

Applicant's summary and conclusion

Conclusions:
The rat oral LD50 for the test-substance is >2000 mg/kg bw. and no adverse effects were observed at this dose level.