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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1999-06-09 to 1999-07-13
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report date:
2000

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
(1996)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Version / remarks:
(1996)
Deviations:
no
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
[4-[[4-(dimethylamino)phenyl]-[4-(ethylamino)-3-methyl-phenyl]methylene]-2-methyl-cyclohexa-2,5-dien-1-ylidene]-ethyl-ammonium;acetate
Molecular formula:
C27H34N3 C2H3O2
IUPAC Name:
[4-[[4-(dimethylamino)phenyl]-[4-(ethylamino)-3-methyl-phenyl]methylene]-2-methyl-cyclohexa-2,5-dien-1-ylidene]-ethyl-ammonium;acetate
Details on test material:
- Substance type: organic
- Physical state: liquid
- Analytical purity: 45 %
- Storage condition of test material: at room temperature

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Boehringer Ingelheim Pharma KG
- Age at study initiation: young adults
- Weight at study initiation: males: 172 - 184 g; females: 178 - 192 g
- Fasting period before study: 16 hours prior to treatment
- Housing: individually
- Diet: Kliba-Labordiaet, Provimi Kliba SA, Kaiseraugst, Switzerland, ad libitum
- Water: Tap water ad libitum
- Acclimation period: at least one week.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 2 and 5 g/100 mL

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg

CLASS METHOD
- Rationale for the selection of the starting dose: Based on the physical and chemical characteristics of the test substance and the composition a starting dose of 500 mg/kg body weight has been chosen.
Doses:
200, 500 mg/kg
No. of animals per sex per dose:
3
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 200 - <= 500 mg/kg bw
Based on:
test mat.
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 125 - <= 312 mg/kg bw
Based on:
act. ingr.
Remarks on result:
other: recalculated based on dye content of registered substance (72% w/w) versus tested material (45% w/w)
Mortality:
At 200 mg/kg bw no animal died. 1 male and one female died within the first day after the application in the high dose group. A second female deceased until day 5 after the application.
Clinical signs:
other: Clinical symptoms were more pronounced in females. Males-200 mg/kg bw: Impaired general state, dyspnoea and piloerection in one animal disappeared within one day. Males-500 mg/kg bw: Impaired general state, dyspnoea, piloerection, poor general state and
Gross pathology:
No gross internal lesions were observed in sacrificed animals. The animals that died during the study showed a discolouration of contents of the stomach and small and large intestines. One animal showed a discolouration of the adrenal glands.

Applicant's summary and conclusion