Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1967-03-22 to 1967-04-05
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study predating guidelines and GLP, but meeting the principles of OECD TG 401.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1967
Report Date:
1967

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
(Study predating Guideline)
Deviations:
not applicable
Principles of method if other than guideline:
Method: other: BASF test
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material: N-Acetylmorpholin

Test animals

Species:
rat
Strain:
other: "US-rats"
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 166 - 280 g (males); 156 - 200 g (females)

ENVIRONMENTAL CONDITIONS
- no data

IN-LIFE DATES: From: 1967-03-29 To: 1967-04-05

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: aqueous tragacanth emulsion
Details on oral exposure:
VEHICLE
- Vehicle concentration: 30% (6400, 3200 mm3/kg bw) , 20% (1600 mm3/kg bw), 2% (200 mm3/kg bw)

MAXIMUM DOSE VOLUME APPLIED:
21, 3 mL / kg
Doses:
6400, 3200, 1600 or 200 mm3 / kg bw, corresponds to:
7136, 3568, 1784 or 223 mg / kg bw ; calculation based on density of test item
No. of animals per sex per dose:
5 males and 5 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 7 days
- Frequency of observations and weighing: body weight taken at study start only for dose determination, but not reported
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs monitored but frequency unknown, gross necropsy on fatalities
Statistics:
not performed

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 7 136 mg/kg bw
Based on:
test mat.
Remarks on result:
other: Liquid: calculation based on density
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 6.4 mL/kg bw
Based on:
test mat.
Mortality:
6400 mm3 / kg bw: 3/10 (1/10 within 24 h, 2/10 within 48 h)
3200 mm3 / kg bw: 0/10
1600 mm3 / kg bw: 1/10 (between day 2 and day 7)
200 mm3 / kg bw: 0/10
Clinical signs:
3200 and 6400 mm3 / kg bw: Laboured breathing, hunched posture, ptosis, red crust around eyes and snout, mild apathy, ruffled fur (on day of dosing, surviving animals recuperated)
Body weight:
No data reported
Gross pathology:
Chronic bronchitis and brochiectasis (10x, non test item related)
Perished animals: bloated stomach (2x), bloated gut (1x), pallid liver (1x)
Other findings:
None

Applicant's summary and conclusion