Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Acute Toxicity: oral

Currently viewing:

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
08. Jan to 04. March 1985
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:
1985
Report date:
1985

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
2-[[(4-methoxyphenyl)methylhydrazono]methyl]-1,3,3-trimethyl-3H-indolium acetate
EC Number:
261-448-2
EC Name:
2-[[(4-methoxyphenyl)methylhydrazono]methyl]-1,3,3-trimethyl-3H-indolium acetate
Cas Number:
58798-47-3
Molecular formula:
C20H24N3O.C2H3O2 C22H27N3O3
IUPAC Name:
2-[(4-methoxybenzyl)carbonohydrazonoyl]-1,3,3-trimethyl-3H-indolium acetate
Details on test material:
- Name of test material (as cited in study report): Astrazon Goldgelb GL flüssig 200% 2.Umstellung

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Winkelmann, Borchen, Germany
- Age at study initiation: males: 9 weeks; females: 14 weeks
- Weight at study initiation: males: 171 g; females: 168 g
- Fasting period before study: 16 hours prior to 4 hours after dosing
- Housing: 5 per cage
- Diet (ad libitum): Altromin 1324
- Water (ad libitum): tap
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.5-23.5
- Humidity (%): 55-65
- Air changes (per hr): -
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: 08. Jan to 04. Mar 1985

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 3.1 mL/kg
Doses:
0.1, 0.5, 1, 2, 3.1 mL/kg bw
110.5, 552.5, 1105, 2210, 3425.5 mg/kg
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
- clinical signs: Day 1: multiple times
Days 2 to 14: 2/day on weekends and holidays 1/day
- body weight: begin and end of study
- Necropsy of survivors performed: yes
Statistics:
LD50 calculation

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD50
Effect level:
0.82 mL/kg bw
95% CL:
0.6 - 1.2
Remarks on result:
other: slope=1.43
Sex:
male/female
Dose descriptor:
LD50
Effect level:
906 mg/kg bw
95% CL:
663 - 1 326
Remarks on result:
other: 1.43
Mortality:
mL/kg bw deaths
0.1 0
0.5 3
1 5
2 9
3.1 10
Clinical signs:
other: poor general condition, narcosis, prone/lateral position, piloerection no effects at 0.1 mL/kg
Gross pathology:
Death animals:
0.5 to 3.1 mL/kg: stomach mucosa: folds decreased; stomach and intestines discolored

Surviving rats: no effects

Applicant's summary and conclusion

Interpretation of results:
Toxicity Category III
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The LD50 in male and female rats was 0.82 mL/kg bw (906 mg/kg bw). No clinical signs or deaths were observed at 0.1 mL/kg bw (110.5 mg/kg bw).
The test substance has to be classified as harmful according to the EU directive.