[2-[[4-[(2-chloro-4-nitrophenyl)azo]phenyl]ethylamino]ethyl](2-hydroxypropyl)dimethylammonium acetate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1984-10-23 to 1984-12-11

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1984

Report date:

1984

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

[2-[[4-[(2-chloro-4-nitrophenyl)azo]phenyl]ethylamino]ethyl](2-hydroxypropyl)dimethylammonium acetate

EC Number:

279-919-6

EC Name:

[2-[[4-[(2-chloro-4-nitrophenyl)azo]phenyl]ethylamino]ethyl](2-hydroxypropyl)dimethylammonium acetate

Cas Number:

82205-20-7

Molecular formula:

C21H29ClN5O3.C2H3O2

IUPAC Name:

N-{2-[{4-[(2-chloro-4-nitrophenyl)diazenyl]phenyl}(ethyl)amino]ethyl}-2-hydroxy-N,N-dimethylpropan-1-aminium acetate

Test material form:

liquid

Details on test material:

see below

Test animals

Species:

rat

Strain:

Wistar

Remarks:

Bor: WISW (SPF CpB)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Winkelmann, Borchen, Germany
- Age at study initiation: 9 weeks (males), 14 weeks (females)
- Weight at study initiation: males: 174 g, females: 173 g
- Fasting period before study: 16 hours before and 4 hours after application
- Housing: 5 animals in macrlon cage type III
- Diet (e.g. ad libitum): Altromin R 1324, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 1.5
- Humidity (%): 60 +/- 5
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: not specified

Doses:

2.0, 3.1, 3.5, 4.0, 5.0, 6.3 mL/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: at least twice a day (weekends once a day)
- Frequency of weighing: before application and after 14 days
- Necropsy of survivors performed: yes

Statistics:

LD50 calculations were performed after Rosiello AP et al., 1977 [J. Tox. and Environ. Health 3: 797-809]

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

3.8 mL/kg bw

Based on:

test mat.

95% CL:

ca. 3.6 - ca. 4.2

Remarks on result:

other: Based on the density of 1.15 g/mL the LD50 value can be converted to 4370 mg/kg bw

Mortality:

2.0 mL/kg bw: no mortality occurred,
3.1 mL/kg bw: 3/10,
3.5 mL/kg bw: 7/10
4.0 mL/kg bw: 7/10
5.0 mL/kg bw: 8/10
6.3 mL/kg bw: 10/10

Clinical signs:

In the low dose group no signs of toxicity were observed. Clinical signs of toxicity were observed for the dose groups 3.1 to 6.3 mL/kg bw. The clinical signs included reduction of spontaneous activity, piloerection and apathy.

Body weight:

No adverse effects observed

Gross pathology:

Gross pathology evaluation on dead animals of the 3.1 mL to 6.3 mL/kg bw dose groups revealed a reddish colouration of the stomach lining by the test substance. The sacrificed animals at the end of the observation period of the dose groups 2.0 to 5.0 mL/kg bw showed no adverse effects.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

In an acute oral toxicity study, the combined LD50 of the test item was determined to be 3.8 mL/kg bw (equals 4370 mg/kg bw based on the density of 1.15 g/mL) in female and male Wistar rats. By extrapolating the concentration of 57.2% of the target substance within the mixture to 100% the calculated LD50 value would be 2500 mg/kg bw and no classification is warranted in accordance with the CLP regulation.

Executive summary:

In an acute oral toxicity study (equivalent to OECD 401), groups of young Wistar rats (5/sex/dose) were given a single oral dose of the liquid test item (target substance content 57.2%) at doses of 2.0, 3.1, 3.5, 4.0, 5.0 and 6.3 mL/kg bw and were observed for 14 days. Mortality occurred during the first 3 days after application. At 6.3 mL/kg bw all animals died, at 5.0 mL/kg bw eight animals died, at 4.0 mL/kg bw seven animals died, at 3.5 mL/kg bw three animals died and 3.1 mL/kg bw one animal died. In the low dose group no animals died and no signs if toxicity were observed. Clinical signs of toxicity were observed for the dose groups 3.1 to 6.3 mL/kg bw. The clinical signs included reduction of spontaneous activity, piloerection, and apathy. Gross pathology evaluation on dead animals of the 3.1 mL to 6.3 mL/kg bw dose groups revealed a reddish colouration of the stomach lining by the test substance. The sacrificed animals at the end of the observation period of the dose groups 2.0 to 5.0 mL/kg bw showed no adverse effects. Based on the results, the combined oral LD50 was determined to be 3.8 mL/kg bw (equals 4370 mg/kg bw based on the density of 1.15 g/mL). By extrapolating the concentration of 57.2% of the target substance within the mixture to 100% the calculated LD50 value would be 2500 mg/kg bw.