Registration Dossier

Administrative data

Endpoint:
acute toxicity: other routes
Type of information:
experimental study
Adequacy of study:
disregarded due to major methodological deficiencies
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable study report wich meets basic scientific principles. Not relevant for REACH.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977
Report Date:
1977

Materials and methods

Principles of method if other than guideline:
BASF test:
Aqueous solutions of the test substance were injected into the peritoneal cavity of the mice. Group-wise documentation of clinical signs was performed over the 14-day study period. Body weight was determined before the start of the study only, as it was needed for determination of dose. The clinical signs and findings were reported in summary form.
GLP compliance:
no
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): N-4 Amin
- Analytical purity: > 97 %

Test animals

Species:
mouse
Strain:
NMRI
Sex:
male/female
Details on test animals and environmental conditions:
- Weight at study initiation: male 18.4 g, females 20.4 g (mean)
- Diet: Altromin R 124 (Altromin GmbH, Lage)

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
water
Doses:
100, 147, 178, 215 and 316 ml/kg bw (corresponding to 95, 140, 169, 204 and 300 mg/kg bw)
No. of animals per sex per dose:
5
Control animals:
no

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 171 mg/kg bw
Mortality:
Mortality occured within 24 hours in the 204 and 300 mg/kg bw dose groups after injection of the test substance.
Clinical signs:
Dyspnoea, tremor, tonic convulsions, apathy, abdominal position, poor general state, spastic gait.
Body weight:
Body weight gain was generally observed in the course of the study.
Gross pathology:
No abnormalities were noted at necropsy of animals died during the study or sacrificed at the end of the study.

Any other information on results incl. tables

Dose

(mg/kg bw)

 

Mortality

Dead/Treated

1 hour

24 hours

48 hours

7 days

14 days

male

female

male

female

male

female

male

female

male

female

95

0/5

0/5

0/5

0/5

0/5

0/5

0/5

0/5

0/5

0/5

140

0/5

0/5

0/5

0/5

0/5

0/5

0/5

0/5

0/5

0/5

169

0/5

0/5

0/5

0/5

0/5

0/5

0/5

0/5

0/5

0/5

204

0/5

0/5

0/5

3/5

3/5

3/5

3/5

4/5

3/5

4/5

300

0/5

0/5

5/5

5/5

5/5

5/5

5/5

5/5

5/5

5/5

Applicant's summary and conclusion