Registration Dossier

Administrative data

Endpoint:
acute toxicity: other routes
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Meets generally accepted scientific standards, well documented and acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report Date:
1987

Materials and methods

Principles of method if other than guideline:
The acute intraperitoneal toxicity was determined in mice
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): N-(2-Ethylhexyl)-2-napthalinamin
- Physical state: liquid
- Analytical purity: 80%
- Impurities (identity and concentrations): 20% Shellsol
- Lot/batch No.: 79/502

Test animals

Species:
mouse
Strain:
NMRI
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Wiga
- Weight at study initiation: mean males and females: 22-24 g
- Fasting period before study: 15-20 h before application
- Housing: no data
- Diet: Herilan MRH-Haltung, no further data
- Water: no data
- Acclimation period: no data


ENVIRONMENTAL CONDITIONS
no data

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
CMC (carboxymethyl cellulose)
Details on exposure:
VEHICLE
- Concentration in vehicle: 2 and 7 %
- Justification for choice of vehicle: none given

MAXIMUM DOSE VOLUME APPLIED:
10 ml/kg
Doses:
200 and 700 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: day 0, day 2-4, day 7 and day 10-13
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Statistics:
no data

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 200 - < 700 mg/kg bw
Mortality:
at 200 mg/kg bw no death occured; at 700 mg/kg bw 5/5 male and 1/5 female animals died
Clinical signs:
at 200 mg/kg dose level: dyspnea, apathy, spastic gait, stretching, scrubby fur and bad general condition was observed
at 700 mg/kg dose level: dyspnea, apathy, staggering, spastic gait, stretching, orange urine, scrubby fur and bad general condition was observed
Body weight:
mean body weight males at 200 mg/kg: day 0: 24 g, day 2-4: 25 g, day 7: 30.2g, day 9-13: 31 g
mean body weight females at 200 mg/kg: day 0: 24 g, day 2-4: 27 g, day 7: 27.4g, day 9-13: 30 g
mean body weight males at 700 mg/kg: day 0: 22 g, day 2-4: 17 g, no futher weighings due to death of the animals
mean body weight females at 700 mg/kg: day 0: 22 g, day 2-4: 19.6 g, day 7: 24 g, day 9-13: 26.2 g
Gross pathology:
no findings

Applicant's summary and conclusion