Registration Dossier

Administrative data

Endpoint:
acute toxicity: other routes
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Animal experimental study, predates implementation of GLP and/or development of study guidelines, limitations in design and/or reporting but otherwise adequate for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1974
Report Date:
1974

Materials and methods

Principles of method if other than guideline:
According to BASF-internal standard: Five to ten NMRI mice per sex per dose were exposed to the test substance dissolved in carboxymethyl cellulose (with 2-3 drops Cremophor EL) via intraperitoneal injection. Animals received 200, 250, 320, 400, 800, 1600 mg/kg bw. After an observation period of 7-14 days animals were necropsied.
GLP compliance:
no
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Dioxyäthyl-anilin

Test animals

Species:
mouse
Strain:
NMRI
Sex:
male/female

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
CMC (carboxymethyl cellulose)
Remarks:
with 2-3 drops Cremophor EL
Details on exposure:
Test concentrations used were 2, 4, 8 and 16%
Doses:
200, 250, 320, 400, 800, 1600 mg/kg bw
No. of animals per sex per dose:
- 200, 400, 800 mg/kg bw: 10
- 250, 320, 1600 mg/kg bw: 5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 7 days (all groups) or 14 days (320, 400, 800 mg/kg bw)
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 360 mg/kg bw
Mortality:
7-DAYS FOLLOW-UP
- 200 mg/kg bw: 0/10 females and 0/10 males within 7 days
- 250 mg/kg bw: 0/5 females died within 7 days. 1/5 males died within 24 hours and 1/5 within 7 days
- 320 mg/kg bw: 1/5 females died within 7 days and 0/5 males within 7 days
- 400 mg/kg bw: 1/10 females died within 48 hours, 4/10 females within 7 days. 4/10 males died within 24 hours, 2/10 within 48 hours, 1/10 within 7 days
- 800 mg/kg bw: 9/10 females died within 24 hours, the remaining female died within 48 hours. 9/10 males died within 24 hours, the remaining male died within 48 hours.
- 1600 mg/kg bw: 3/5 females died within one hour and the remaining animals died within 24 hours. 2/5 males died within one hour and 2/5 died within 24 hours.

14-DAYS FOLLOW-UP
- 320 mg/kg bw: 1/5 females and 0/5 males after 14 days
- 400 mg/kg bw: 3/5 females and 4/5 males after 14 days
- 800 mg/kg bw: 5/5 females and 5/5 males after 14 days
Clinical signs:
Dyspnea, staggering, partly atony and narcotic-like state, abdominal and dorsal position, clonic spasms, apathy were observed.
Body weight:
Normal body weight gain was observed
Gross pathology:
No intra-abdominal substance residues or adhesions were observed.

Applicant's summary and conclusion