Cobaltate(3-), bis[6-amino-5-[(2-hydroxy-3,5-dinitrophenyl)azo]-1-naphthalenesulfonato(3-)]-, sodium

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

other: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

The complete read across justification is detailed in section 13; source study has reliability 1.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2015

Report date:

2015

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Similar Substance 01

IUPAC Name:

Similar Substance 01

Test material form:

solid

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Wiga GmbH, Germany
- Age at study initiation: young adult animals (female animals approx. 10 weeks)
- Weight at study initiation: Animals of comparable weight (± 20 % of the mean weight)
- Fasting period before study: feed was withdrawn from the animals at least 16 hours before administration, but water was available ad libitum.
- Housing: single housing
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days before the beginning of the experimental phase

ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 3 °C
- Humidity: 30 – 70 %
- Air changes per hr: approx. 10
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 20 g / 100 ml
- Amount of vehicle (if gavage): 10 ml/kg bw
- Justification for choice of vehicle: aqueous preparation corresponds to the physiological medium.

MAXIMUM DOSE VOLUME APPLIED: 10 ml/ kg bw

Doses:

2000 mg/kg

No. of animals per sex per dose:

6 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: a check for any dead or moribund animals was made at least once each workday; clinical signs for each animal were recorded several times on the day of administration and at least once during each workday thereafter. Individual body weights shortly before administration (day 0), weekly thereafter and on the last day of observation.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathology

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: no mortality was observed

Mortality:

No mortality occurred in both test groups.

Clinical signs:

other: other: All animals of the first 2000 mg/kg bw test group showed impaired general state and piloerection from hour 2 until hour 3 after administration. In one of these animals the same findings were noted again at hour 5. No clinical signs were noted in th

Gross pathology:

There were no macroscopic pathological findings in the animals sacrificed at the end of the observation period (6 females).

Any other information on results incl. tables

Under test conditions, the median lethal dose of test substance was found to be greater than 2000 mg/kg bw in rats.

The following test substance-related clinical observations were recorded; clinical signs occurred within 3 days after administration at the latest:

2000 mg/kg (first test group): no mortality; impaired general state in all animals; piloerection in all animals

2000 mg/kg (second test group): no clinical signs and no mortality

The body weight of the animals in both test groups increased within the normal range throughout the study period with two exceptions in the first test group. In these two animals the body weights were within the normal range during the first week, but stagnated during the second week. This effect is observed at times in the rat strain used, because in the required age range the female animals have already reached the phase of slow growth. There were no macroscopic pathological findings in the animals sacrificed at the end of the observation period (6 females).

Applicant's summary and conclusion

Interpretation of results:

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

Conclusions:

LD50 (rat) > 2000 mg/kg bw

Executive summary:

Method

Evaluation of acute toxicity by oral route in rats, according to OECD guideline 423. Single dose administration by gavage was followed by a 14 -day observation period.

Results

LD50 > 2000 mg/kg. No clinical signs and no macroscopic changes were reported.

The following test substance-related clinical observations were recorded. Clinical signs occurred within 3 days after administration at the latest:

2000 mg/kg (first test group): no mortality; impaired general state in all animals; piloerection in all animals

2000 mg/kg (second test group): no clinical signs and no mortality