Reaction products of 6-amino-4-hydroxynaphthalene-2-sulphonic acid and 7-amino-4-hydroxynaphthalene-2-sulphonic acid, condensed with Formaldehyde and Sodium hydrogensulfite, coupled with diazotised Sodium 2-amino-4,6-dinitrophenoxide, metalized with Sodium Dichromate, sodium salts

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1985

Report date:

1985

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

1981

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Reaction products of 6-amino-4-hydroxynaphthalene-2-sulphonic acid and 7-amino-4-hydroxynaphthalene-2-sulphonic acid, condensed with Formaldehyde and Sodium hydrogensulfite, coupled with diazotised Sodium 2-amino-4,6-dinitrophenoxide, metalized with Sodium Dichromate, sodium salts

EC Number:

947-452-3

Molecular formula:

not applicable

IUPAC Name:

Reaction products of 6-amino-4-hydroxynaphthalene-2-sulphonic acid and 7-amino-4-hydroxynaphthalene-2-sulphonic acid, condensed with Formaldehyde and Sodium hydrogensulfite, coupled with diazotised Sodium 2-amino-4,6-dinitrophenoxide, metalized with Sodium Dichromate, sodium salts

Test material form:

solid: particulate/powder

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
-Source: Charles River France (76410 Saint Aubin les Elbeuf, France)
-Age at study initiation:
-Weight at study initiation: 130 g ♂, 129 g ♀
-Fasting period before study: prior to gavage, the animals were fasted overnight. Food was given again 4 hours after treatment.
-Housing: t he animals were kept in sterilized polycarbonate cages (5 animals per cage) with a size of 42,0 x 27,0 x 15,0 cm covered with a stainless steel wire mesh lid and containing food and a water bottle. The bedding was sterilized wooden saw dust (Supplier : Société Parisienne des Sciures, 93500 Pantin, France). Wooden saw dust analysis of the contaminants was carried out periodically performed by the Laboratoire Municipal de Rouen (76000 Rouen, France).
-Diet: the animals were fed with a certified pelleted diet (Rat and Mice n° 1, Expanded SOC, Special Diets Services Ltd, witham, Essex, England). Food was given ad libitum during all the study
-Water: the animals had free access to tap water filtered with Millipore filters (0,22 micron) in water bottles. Bacteriological water analysis, chemical analysis and detection of major contaminants were performed regularly (Laboratoire Municipal, 76000 Rouen, France).
-Acclimation period: 7 days, during this period, the animals were observed daily.

ENVIRONMENTAL CONDITIONS
-Temperature: 21°C ± 3 °C
-Humidity: 50 % ± 20 %
-Air changes: The incoming, non-recycled air, was filtered by an absolute filter.
-Photoperiod: The light/dark cycle was 12 hours per day.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Control animals:

no

Details on study design:

-Duration of observation period following administration: 14 days
-Frequency of observations: the animals were observed frequently the day of treatment and twice daily during the observation period to note any change in behaviour or health condition.
-Frequency of weighing: body weights were recorded on D 0, D 4, D 7 and D 14.
-Mortality: the mortality was checked daily during the observation period.
-Necropsy of survivors performed: yes
-Other examinations performed: The macroscopic examination of the main organs was performed on all animals killed by CO2 asphyxiation at the end of the observation period.

Results and discussion

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Effect levels 2

Sex:

male/female

Dose descriptor:

LD0

Effect level:

5 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred during the observation period.

Clinical signs:

A slight hypokinesia was observed after treatment but the general behaviour of the animals was not influenced by the treatment.

Body weight:

The body weight gain of rnale and female animals was not influenced by the treatment.

Gross pathology:

No macroscopic abnormalities were observed at necropsy. Consequently no sampling of tissues and no histological investigations were performed.

Applicant's summary and conclusion

Interpretation of results:

other: not classified according to the CLP Regulation (EC 1272/2008)

Conclusions:

The LD50 (oral, rat) was found to be greater than 5000 mg/kg bw.

Executive summary:

The substance was tested for acute oral toxicity study in five male and five female rats, according to the OECD Guideline 401 (1981). No death occurred after a single administration of 5000 mg/kg which corresponds to the maximum administrable dose level.

A slight hypokinesia was observed after treatment but the behaviour and body weight gain of the animals were not influenced by the treatment. The macroscopic investigations revealed no lesion in the animals sacrificed at the end of the observation period.

The oral LD50 value of the substance in rats was established to exceed 5000 mg/kg bw.