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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
1983
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report date:
1983

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Principles of method if other than guideline:
5 male and 5 female Wistar rates were dosed with 5000 mg/kg test item and a volume of 20 ml/kg; vehicle: Lutrol. Animals were observed for 14 days.
GLP compliance:
no
Test type:
other: Limit test with 5000 mg/kg
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Methyl 2-[(1,5-dihydro-3-methyl-5-oxo-1-phenyl-4H-pyrazol-4-ylidene)ethylidene]-1,3,3-trimethylindoline-5-carboxylate
EC Number:
227-217-5
EC Name:
Methyl 2-[(1,5-dihydro-3-methyl-5-oxo-1-phenyl-4H-pyrazol-4-ylidene)ethylidene]-1,3,3-trimethylindoline-5-carboxylate
Cas Number:
5718-26-3
Molecular formula:
C25H25N3O3
IUPAC Name:
methyl 1,3,3-trimethyl-2-[2-(3-methyl-5-oxo-1-phenyl-1,5-dihydro-4H-pyrazol-4-ylidene)ethylidene]indoline-5-carboxylate
Test material form:
solid
Specific details on test material used for the study:
Macrolex Orange 51032 (Oek.-Nr.: 826-152)
Solid powder

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
5 male and 5 female Wistar rates were dosed with 5000 mg/kg test item and a volume of 20 ml/kg; vehicle: Lutrol. Animals were observed for 14 days.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: Lutrol
Details on oral exposure:
5 male and 5 female Wistar rates were dosed with 5000 mg/kg test item and a volume of 20 ml/kg; vehicle: Lutrol. Animals were observed for 14 days.
Doses:
5000 mg/kg
No. of animals per sex per dose:
5 male and 5 female Wistar rates
Control animals:
no
Details on study design:
5 male and 5 female Wistar rates were dosed with 5000 mg/kg test item and a volume of 20 ml/kg; vehicle: Lutrol. Animals were observed for 14 days.
Statistics:
no

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
discriminating dose
Effect level:
5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
not determinable due to absence of adverse toxic effects
Mortality:
no
Clinical signs:
other: no effect
Gross pathology:
no effect
Other findings:
no

Any other information on results incl. tables

Mortality: 0/10

Symthomes: 0/10

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Executive summary:

In the acute oral study 5 male and 5 female Wistar rates were dosed with 5000 mg/kg test item. No symptoms or mortality were observed. Consequently the discriminating dose is 5000 mg/kg (highest dose tested)