Reaction products of 2-amino-4,6-dinitrophenol, 4-amino-5-hydroxy 2,7-naphthalenedisulfonic acid, 4-nitrobenzenamine and resorcinol, sodium salts

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 23rd of November to 14th of December, 1988

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

Study conducted according to internationally accepted guideline.

Justification for type of information:

Justification for Read Across is detailed in the endpoint summary and it is further detailed in the report attached to the IUCLID section 13.

Cross-reference

Reason / purpose for cross-reference:

read-across source

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1989

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Similar substance 01 of Acid Brown 191

IUPAC Name:

Similar substance 01 of Acid Brown 191

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: Kleintierrarm Madoerin AG, CH 4414 Fuellinsdorf Switzerland
Age at start of treatment males: 7 weeks, females: 9 weeks
Body weight at start of treatment males: 174- 186 g, females: 152 - 164 g
Identification: by unique cage number and corresponding color-coded spots on the tail.
Randomization: randomly selected at time of delivery in groups of five.
Acclimatization At least one week under laboratory conditions, after veterinary examination.
ENVIRONMENTAL CONDITIONS
Room No: 136
Standard Laboratory Conditions:
Air-conditioned with 10-15 air changes per hour, and hourly monitored environment with temperature 22 ± 3 °C centigrade, relative humidity 40-70 %, 12 hours artificial fluorescent light/12 hours dark, music-light period.
Accommodati on: groups of five in Nakrolon type-3 cages with standard softwood bedding (‘Lignocel’, Schill AG, 4132 Nuttenz, Switzerland).
Diet: pelleted standard Kliba 343
Batch 34/88 rat maintenance diet (‘Kliba’, Klingentalmuehle AG, 4303 Kaiseraugst, Switzerland) available ad libitum.
Analysis for contaminants were performed.
Water: community tap water from Itingen, available ad libitum.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

The animals received a single dose of the test article on a mg/kg body weight base by oral gavage after being fasted for 12 to 18 hours (access to water was not interrupted). Food was again presented approximately one hour after dosing.

Doses:

Application Volume/kg body weight: 10 ml at 2000 mg/kg.

No. of animals per sex per dose:

5 males
5 females

Control animals:

yes

Details on study design:

OBSERVATION
Mortality /Viability: Four times during test day 1, and daily during days 2—15;
Body Weights: Test days 1 (pre—administration), 8 and 15.
Symptoms: ach animal was examined for changes in appearance and behavior four times during day 1, and daily during days 2—15.
All abnormalities were recorded: general behaviour, respiration, eye, nose, motility, body posture, motor supsceptibility, skin, various.
Pathology:Necropsies were performed by experienced prosectors.
All animals were necropsied. All animals were killed by intraperitoneal injection of sodium pentobarbitone and discarded.
The following data were recorded on data sheets and transcribed for compilation and analysis:signs and symptoms, mortality, body weights, necropsy, macroscopic findings (on—line).

Statistics:

The LOGIT-Model could not be applied to the observed rates or death. The toxicity was estimated without use of a statistical model.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

not specified

Mortality:

No death occurred during the study

Clinical signs:

other: Sedation was observed at 2000 mg/kg and the animals had recovered within 2 observation days.

Gross pathology:

Macroscopical examination: no findings noted

Applicant's summary and conclusion

Interpretation of results:

other: not classified as harmful/toxic according to the CLP Regulation (EC) No.1272/2008

Conclusions:

LD50 > 2000 mg/kg bw

Executive summary:

Method

The test article was administered to rats of both sexes by oral gavage, at a dose of 2000 mg/kg, according to the OECD Guideline 401.

Observation

The following death rate was observed: 0 % at 2000 mg/kg

The LOGIT-Model could not be applied to these data. The acute oral toxicity of the substance in rats of both sexes, observed over a period of 15 days, was estimated to be greater than 2000 mg/kg.

Sedation was observed at 2000 mg/kg and the animals had recovered within 2 observation days. No macroscopical organ changes were observed.

Results

LD50 > 2000 mg/kg bw