3,7-bis(diethylamino)phenoxazin-5-ium nitrate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

May/Jun 1982

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:

3,7-bis(diethylamino)phenoxazin-5-ium tetrachlorozincate (2:1)

EC Number:

264-355-5

EC Name:

3,7-bis(diethylamino)phenoxazin-5-ium tetrachlorozincate (2:1)

Cas Number:

63589-47-9

Molecular formula:

C20H26N3O.1/2Cl4Zn

IUPAC Name:

bis[3,7-bis(diethylamino)phenoxazin-5-ium] tetrachlorozincate(2-)

Test material form:

solid: particulate/powder

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: ca. 9 wks (male), ca. 14 wks (female)
- Weight at study initiation: 157 - 189 g (male), 152 - 174 g (female)
- Fasting period before study: 4 - 16 h
- Housing: Makrolon III cage, 5 animals per cage
- Diet (e.g. ad libitum): ad lib.
- Water (e.g. ad libitum): ad lib.

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

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Remarks:

tap water

Details on oral exposure:

VEHICLE
- Amount of vehicle (if gavage): 20 mL/kg
- Justification for choice of vehicle: water soluble

MAXIMUM DOSE VOLUME APPLIED: 20 mL/kg

Doses:

63, 100, 200, 225, 250, 310 mg/kg bw

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: observations daily, weighing on day 0, 7 and 14
- Necropsy of survivors performed: yes, randomly (not all animals)
- Other examinations performed: clinical signs, body weight

Statistics:

Probit analysis

Results and discussion

Effect levels

Effect levels 1

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

130 mg/kg bw

Based on:

act. ingr.

95% CL:

114 - 140

Effect levels 2

Sex:

male/female

Dose descriptor:

LD50

Effect level:

217 mg/kg bw

Based on:

test mat.

95% CL:

> 190 - < 234

Mortality:

high dose: 100%
2 lowest doses: 0%

Clinical signs:

in all concentrations except low dose (from 1 min up to 2 d after dosing): bad general condition, sedation, prone and lateral position, nausea, breathing difficulties, no difference in sexes

Body weight:

no effects

Gross pathology:

two highest doses: no pathology of stomach/intestine possible due to heavy staining and discolouration, other organs w/o effects
mid doses: slight gastritis
low dose: no effects

Applicant's summary and conclusion

Interpretation of results:

Category 3 based on GHS criteria

Conclusions:

The substance was admintered orally (gavage) in male and female rats. The LD50 was determined at 130 mg/kg bw (act. ingr.). Therefore, the source substance is classified as Category 3 for acute oral toxicity. The 95% CI interval is within the range of GHS Category 3, too.