2-(4-amino-2-nitroanilino)ethanol

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 6 June 1983 to August 1983

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

No GLP, comparable to OECD Guideline 405 method. No information about the test item was provided (batch, purity, solubility)

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)

Deviations:

yes

Remarks:

No GLP, comparable to OECD Guideline 405 method. No information about the test item was provided (batch, purity, solubility)

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

2-(4-amino-2-nitroanilino)ethanol

EC Number:

220-701-7

EC Name:

2-(4-amino-2-nitroanilino)ethanol

Cas Number:

2871-01-4

Molecular formula:

C8H11N3O3

IUPAC Name:

2-(4-amino-2-nitroanilino)ethanol

Test material form:

solid: particulate/powder

Remarks:

crystalline powder

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: porvided by the company company Hans Schwarzkopf GmbH
- Expiration date of the lot/batch: not specified
- Purity test date:not specified

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: at room temperature in the dark

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
For the test, the test powder was suspended 25 % in 0.5 % carboxymethylcellulose (CMC).

Test animals

Species:

rat

Strain:

other: BOR: WISW

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Firma Winklemann
- Females (if applicable) nulliparous and non-pregnant: not specified
- Age at study initiation: not specified
- Weight at study initiation: males : 160.0 – 199.8 g / females : 140.0 – 174.0 g
- Fasting period before study: not specified
- Housing: Makrolon Type III, maximum of 5 rats were housed together
- Diet (e.g. ad libitum): Ssniff-R (Complete diet for rats) ad libitum
- Water (e.g. ad libitum): tap water by Makrolon drinking bottles, ad libitum
- Acclimation period: about 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ºC ± 2 ºC
- Humidity (%): 50 - 85 %
- Air changes (per hr): not specified
- Photoperiod (hrs dark / hrs light): 12h/12 hours light daily, from 7.00 to 19.00

IN-LIFE DATES: From: 16 June 1983 To: 7 July 1983

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 25%

MAXIMUM DOSE VOLUME APPLIED: no constant volume applied 0.56 to 3.8 mL

DOSAGE PREPARATION (if unusual): For the test, the test powder was suspended 25 % in 0.5 % carboxymethylcellulose (CMC).

Doses:

1000, 2500, 3500 mg/kg

No. of animals per sex per dose:

Five animals per dose per sex were used

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The assessment of the clinical-toxicological symptoms was carried out individually and was focused on the course of symptoms. e.g. if the effect was constant over a considerable time, this was noted in the appropriate records.
Another assessment is only made if the symptoms change.
Assessment was made at the following times: 30', 1 + 2 h, 3 + 6 h, 24 h, 48 h,
72 h, 7 and 14 days p.a.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weight

Statistics:

Calculation of the oral LD50 was carried out in that case using the probit analysis after D. Y. Finney: Probit Analysis, 3rd Edition, Cambridge 1971

Results and discussion

Preliminary study:

This preliminary test showed (two females rats were exposed at the dose of 1.0, 2.5, 3.5, 5 g/kg) that both animals used with 5 g/kg perished within 24 hours p.a.. One animal died within 24 h p.a. at 2.5 g/kg. At 1.0 g/kg no mortality was found.

Effect levels

Effect levels 1

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

3 940 mg/kg bw

Based on:

test mat.

Effect levels 2

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

2 950 mg/kg bw

Based on:

test mat.

Effect levels 3

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

3 400 mg/kg bw

Based on:

test mat.

Mortality:

At the dose of 5 g/kg bw, 9 of 10 rats died within 24h. At the dose of 3.5 g/kg bw, 4 of 10 rats died within 24h and a total of 6 after 48h. 1 of 10 rats died within 24h at the dose of 2.5 g/kg bw. No mortalities were observed at 1g/kg

Clinical signs:

other: At the tested dosages, the preparation increasingly caused reduced activity with apathy, partly significant anomalies in posture and positioning, predominantly significant disturbance to coordination, partly slight to significantly reduced tone in digits

Gross pathology:

In the mortalities, red-blue discolouration and sometimes accumulations of liquid in the whole gastro-intestinal tract were found. In the dissection of all surviving animals at the end of the 14-day post-observation period, no macroscopically visible organ changes were found in the cranial, chest or abdominal cavities.

Any other information on results incl. tables

Table1 :Summary of the results  – Body weights

Group	Dose	original weight	Number of animals	final weight	Number of remaining animals
I	1.0 g/kg	159.35	10	181.70	10
II	2.5 g/kg	164.43	10	187.44	9
III	3.5 g/kg	166.69	10	204.00	4
IV	5.0 g/kg	168.84	10	212.00	1

 

Table2 :Summary of the results – Mortality

24 h	LD50	3/14 days	LD50
Males	4.20 g/kg	Males	3.94 g/kg
Females	3.15 g/kg	Females	2.95 g/kg
Males and Females	3.64 g/kg	Males and Females	3.40 g/kg

 

Applicant's summary and conclusion

Interpretation of results:

Category 5 based on GHS criteria

Conclusions:

Under the experimental conditions opf this study, the results of the test indicated that the lethal oral dose (LD5O) was 3940 mg/kg in males and 2950 mg/kg in females, for males and females the LD40 value was 3400 mg/kg. hence, the test item HC Red 3 was not classififed as Acute Oral Hazard according to CLP regulation, and was classified Category 5 according to GHS criterias.

Executive summary:

The aim of this no-GLP compliant study investigation was to determine the toxic effect of “H.C. Red 3” after a single oral application to the rat.

Male and females Wistar rats of the BOR: WISW strain, in the weight range 160 to 199g (male) and 140-174 g (female) were administered HC Red n° 3 at the doses of 1, 2.5, 3.5 and 5 g/kg bw by oral intubation (5 males and 5 females per dose). During the observation period of 14 days, a record was kept for mortalities and signs of toxicity. Body weights were recorded on day 0 and day 14 for the surviving animals. All rats that died were investigated macroscopically to identify organ changes in the skull, thorax and abdomen and surviving animals were similarly examined at the end of the 14-day post-observation.

At the dose of 5 g/kg bw, 9 of 10 rats died within 24h. At the dose of 3.5 g/kg bw, 4 of 10 rats died within 24h and a total of 6 after 48h. 1 of 10 rats died within 24h at the dose of 2.5 g/kg bw. No mortalities were observed at 1g/kg. Red-blue colorations of mucosae and urine were observed in all rats. At the tested doses, reduced activity was observed during the first 30 minutes and continued in the surviving

rats up to 72h. After that and during the rest of the observation period, these animals had normal appearance.

Under the experimental conditions opf this study, the results of the test indicated that the lethal oral dose (LD5O) was 3940 mg/kg in males and 2950 mg/kg in females, for males and females the LD50 value was 3400 mg/kg. Hence, the test item HC Red 3 was not  classififed as Acute Oral Hazard according to CLP regulation and was classified Category 5 according to GHS criterias.