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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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

Constituent 1
Chemical structure
Reference substance name:
N-(2-ethylhexyl)naphthalen-2-amine
EC Number:
260-126-9
EC Name:
N-(2-ethylhexyl)naphthalen-2-amine
Cas Number:
56358-17-9
Molecular formula:
C18H25N
IUPAC Name:
N-(2-ethylhexyl)naphthalen-2-amine
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 or test system 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