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: Study performed according to the OECD guideline 401 and GLP compliant

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report date:
1998

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.1100 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
CA058
IUPAC Name:
CA058
Constituent 2
Chemical structure
Reference substance name:
N-(3-aminopropyl)iminodiethanol
EC Number:
225-642-0
EC Name:
N-(3-aminopropyl)iminodiethanol
Cas Number:
4985-85-7
Molecular formula:
C7H18N2O2
IUPAC Name:
2-[(3-aminopropyl)(2-hydroxyethyl)amino]ethan-1-ol
Constituent 3
Reference substance name:
N-(3-Aminopropyl)diethanolamine
IUPAC Name:
N-(3-Aminopropyl)diethanolamine
Constituent 4
Reference substance name:
APDEA
IUPAC Name:
APDEA
Test material form:
liquid: viscous
Details on test material:
- Name of test material (as cited in study report): CA058
- Physical state: colourless viscous liquid
- Analytical purity: 88.18%
- Impurities (identity and concentrations): no data
- Purity test date: no data
- Lot/batch No.: 6995-91-38
- Expiration date of the lot/batch: no data
- Stability under test conditions: no data
- Storage condition of test material: room temperature in the dark

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River (UK) Ltd., Margate, Kent, UK
- Age at study initiation: eight to twelve weeks
- Weight at study initiation: 214 to 230g (males); 202 to 230g (females)
- Fasting period before study: yes (overnight fast immediately before dosing and for approximately three to four hours after dosing)
- Housing: groups of up to five by sex in solid-floor polypropylene cages furnished with woodflakes
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 to 23 °C
- Humidity (%): 51 to 62 %
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
VEHICLE - none
MAXIMUM DOSE VOLUME APPLIED: 2.14 ml/kg
Doses:
2268mg/kg (equivalent to 2000 mg active ingredient/kg bodyweight)
No. of animals per sex per dose:
5 males and 5 females
Control animals:
no
Details on study design:
Range finding study
A range-finding study was performed to establish a dosing regime as follows: 1 male and 1 female were dosed with 2268 mg/kg of CA058 (equivalent to 2000 mg active ingredient/kg bodyweight). The 2 animals were observed for deaths or overt signs of toxicity 0.5, 1, 2 and 4 hours after dosing and subsequently once daily for five days.
lndividual bodyweights were recorded on the day of dosing to allow calculation of individual treatment volumes. No necropsies were performed.

Main study
- Duration of observation period following administration: 14 days
- Frequency of observations: 0.5, 1, 2, and 4 hours after dosing and subsequently once daily for 14 days.
- Frequency of weighing: prior to dosing on Day 0 and on Days 7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: behavioural and clinical observations, gross lesions.

Results and discussion

Preliminary study:
There were no deaths.
Hunched posture was commonly noted four hours and up to five days after dosing.
Based on this information, a dose level of 2000 mg active ingredient/kg bodyweight was selected for the main study.
Effect levels
Sex:
male/female
Dose descriptor:
LD0
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: There were no deaths at this dose level.
Mortality:
There were no deaths.
Clinical signs:
No signs of systemic toxicity were noted during the study.
Body weight:
All animals showed an expected gain in bodyweight during the study.
Gross pathology:
No abnormalities were noted at necropsy.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute oral LD0 of APDEA, in the Sprague-Dawley CD strain rat was found to be greater than 2000 mg active ingredient/kg bodyweight.
Executive summary:

The study was performed to assess the acute oral toxicity of N-(3-Aminopropyl)diethanolamine in the Sprague-Dawley CD strain rat. The method followed that in the OECD Guidelines for Testing of Chemicals No. 401 "Acute Oral Toxicity" (adopted 24 February 1987), Method 81 of Commission Directive 92/69/EEC (which constitutes Annex V of Council Directive 67/548/EEC) and the US Environmental Protection Agency (EPA) Health Effects Test Guidelines OPPTS 870:1100, 1998.

Following a range-finding study, a group of ten fasted animals (five males and five females) was given a single oral dose of undiluted test material at a dose level of 2268 mg/kg bodyweight (equivalent to 2000 mg active ingredient/kg bodyweight).

The animals were observed for fourteen days after the day of dosing and were then killed and subjected to gross pathological examination.

There were no deaths. No signs of systemic toxicity were noted during the study.

All animals showed an expected gain in bodyweight during the study.

No abnormalities were noted at necropsy.

The acute oral LD0 of the test material in the Sprague-Dawley CD strain rat was found to be greater than 2000 mg active ingredient/kg bodyweight.

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