Dimethyl[4-[4-(dimethylamino)-α-phenylbenzylidene]-2,5-cyclohexadien-1-ylidene]ammonium hydrogen sulphate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Oct - Dec 1981

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1982

Report date:

1982

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Methanaminium, N-[4-[[4-(dimethylamino)phenyl]phenylmethylene]-2,5-cyclohexadien-1-ylidene]-N-methyl-, ethanedioate

EC Number:

241-922-5

EC Name:

Methanaminium, N-[4-[[4-(dimethylamino)phenyl]phenylmethylene]-2,5-cyclohexadien-1-ylidene]-N-methyl-, ethanedioate

Cas Number:

18015-76-4

Molecular formula:

C25H26N2O4

IUPAC Name:

Methanaminium, N-[4-[[4-(dimethylamino)phenyl]phenylmethylene]-2,5-cyclohexadien-1-ylidene]-N-methyl-, ethanedioate

Test material form:

solid: particulate/powder

Details on test material:

Basic Green 4 Oxalate

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

Breeder: Winckelmann, Borchen
Acclimatization period: at least 5 d
Age: 8-10 weeks old
Body weight: 158-197 g (male), 152-180 g (female)
Temperature and relative humidity: 22 +/- 2°C and 55 +/- 5%, respectively
Light period: 12h light/12h dark
Diet and water: Altromin 1324 and tap water, ad libitum

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

The test substance was diluted into water and administered at a constant rate (20 mL/kg bw) by gavage. Animals did not have access to feed and water from 16 h before to 4 h after application.

Doses:

100, 310, 400, 500, 630 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

This was followed by a 14 d observation period. At the end of the study, animals were sacrified and an anatomo-pathological examination was realised.

Statistics:

Probit analysis

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

383 mg/kg bw

Based on:

test mat.

95% CL:

> 330 - < 431

Mortality:

Mortality occurred at >=310 (male) and >= 400 (female) mg/kg bw
All fatal events occurred within the first 2 h after application
No difference between sexes

Clinical signs:

other: All doses, both sexes: bad general condition, sedation >400 (males) and >310 (females) mg/kg: nausea, prone/lateral position All symptoms occurred within 1 min after application and disappeared within 3 days

Gross pathology:

Stomach and gut intensively stained, other organs without effects
Gastritis in some animals at 310 and 500 mg/kg bw

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

Under the study conditions, the oral LD50 (oral, gavage) in male and female rats was determined at 383 mg/kg bw. The substance is classified as acutely toxic (oral) Cat. 4.