Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Acute Toxicity: inhalation

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Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
Only basic data given, equivalent to guideline, no GLP study, the test substance was tested in a different composition as compared to the composition of the registered substance.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report date:
1977

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Deviations:
no
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
2-[2-[4-(dimethylamino)phenyl]vinyl]-1,3,3-trimethyl-3H-indolium acetate
EC Number:
275-654-5
EC Name:
2-[2-[4-(dimethylamino)phenyl]vinyl]-1,3,3-trimethyl-3H-indolium acetate
Cas Number:
71598-17-9
Molecular formula:
C21H25N2.C2H3O2
IUPAC Name:
2-{2-[4-(dimethylamino)phenyl]vinyl}-1,3,3-trimethyl-3H-indolium acetate

Test animals

Species:
rat
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: males: 249 g, females 200 g

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 °C

Administration / exposure

Route of administration:
inhalation
Details on inhalation exposure:
Administration: Inhalation of an atmosphere enriched with volatile components at 20 °C. For enrichment 200 L air/h was flown through a 5cm layer of the product.
Analytical verification of test atmosphere concentrations:
no
Duration of exposure:
7 h
Concentrations:
mean concentration: 14.78 mg/L
No. of animals per sex per dose:
12 animals (sex unspecified)
Control animals:
no
Details on study design:
- method according to HF. Smith and Carpenter: J. Ind. Hyg. Tox. 26, 269 (1944)
- Frequency of observations: after 3 min, after 10 min, after 1 h, after 2 h, after 4 h and after 7 h
- Weighing: At the beginning and at the end of the test


Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 14.78 mg/L air (nominal)
Based on:
test mat.
Exp. duration:
7 h
Mortality:
no animals died
Clinical signs:
other: Slight irritation to the mucosa
Gross pathology:
Organs: No abnormalities detected.

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Remarks:
The acid content in this study is lower than the acid content of the composition of the registered substance. Therefore the results from these studies are not representative for the assessment of this endpoint. The study is only included in the dossier for the sake of completeness.