Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions

Data source

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

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
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 (as cited in study report): N-(2-Ethylhexyl)-2-napthalinamin
- Physical state: liquid

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Hagemann
- Weight at study initiation: males mean 170-220 g; females mean ca. 170 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:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 21.5, 31.6 and 46.4 %
- Amount of vehicle (if gavage): 10 ml/kg
- Justification for choice of vehicle: none given


MAXIMUM DOSE VOLUME APPLIED:
10 ml/kg

Doses:
2150, 3160, 4640 mg/kg
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, day 9-13
- 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:
3 014 mg/kg bw
95% CL:
> 2 547 - < 3 553
Mortality:
at the 2150 mg/kg dose level, 1/5 females and 0/5 males died; at the 3160 mg/kg dose level, 3/5 males and 2/5 females died; at the 4640 mg/kg
dose level all male and all female animals died
Clinical signs:
at 2150 mg/kg dose level: dyspnea, apathy, staggering, scrubby fur, diarrhea and bad general condition was observed
at 3160 mg/kg dose level: dyspnea, apathy, staggering, spastic gait, scrubby fur, diarrhea, exsiccosis and bad general condition was observed
at 4640 mg/kg dose level: dyspnea, apathy, staggering, spastic gait, scrubby fur, diarrhea and bad general condition was observed
Body weight:
mean body weight males at 2150 mg/kg: day 0: 220 g, day 2-4: 207 g, day 9-13: 269 g
mean body weight females at 2150 mg/kg: day 0: 170 g, day 2-4: 170 g, day 9-13: 200 g
mean body weight males at 3160 mg/kg: day 0: 170 g, day 2-4: 141 g, day 7: 185 g, day 9-13: 238 g
mean body weight females at 3160 mg/kg: day 0: 170 g, day 2-4: 145 g, day7: 177 g, day 9-13: 200 g
mean body weight males at 4640 mg/kg: day 0: 170 g, no further body weights were taken due to death of the animals
mean body weight females at 4640 mg/kg: day 0: 170 g, no further body weights were taken due to death of the animals
Gross pathology:
animals that died during the study: heart: acute dilation of the prechamber, acute congestive hyperemia; stomach: stuffed, isolated bloody ulcerations; gut: atonic, content dysenteric
sacrificed animals: without findings

Applicant's summary and conclusion