Strontium 3-hydroxy-4-[(1-sulfonato-2-naphthyl)azo]-2- naphthoate 5/2 hydrate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

7th November 2007- 23rd November 2007

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2008

Report date:

2008

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

484-490-5

EC Name:

-

Molecular formula:

Hill formula:C21 H12 N2 O6 S Sr 5/2(H2O) CAS formula: C21 H14 N2 O6 S . Sr

IUPAC Name:

strontium(2+) 3-hydroxy-4-[(1E)-2-(1-sulfonatonaphthalen-2-yl)diazen-1-yl]naphthalene-2-carboxylate

Test material form:

solid: granular

Details on test material:

Red Powder.
Batch-070711
Purity>=96.4 %
Storage-Room temperature in the dark.
Stable under storage conditions.
Epiry date-11 July 2011

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Deutschland, Sulzfield, Germany
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 9 weeks old
- Weight at study initiation: Does not exceed the mean.
- Fasting period before study: 20 hours.
- Housing: Animals were housed in 3 cages in labelled Macrolon cages containing sterilized sawdust as bedding material and paper as cage- enrichment.
- Diet (e.g. ad libitum): Free access to pelleted rodent diet.
- Water (e.g. ad libitum): Free access to tap water.
- Acclimation period: 5 days.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 23.1 °C
- Humidity (%): 40-80 %
- Air changes (per hr): 15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours artificial light and 12 hours darkness per day.

IN-LIFE DATES: From: 07 November 2007 To: 23rd November 2007

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

propylene glycol

Details on oral exposure:

VEHICLE
- Justification for choice of vehicle: The vehicle was selected based on trial formulations performed at NOTOX and on test substance data supplied by the sponsor.

Doses:

2000 mg/kg (10mL/kg) body weight

No. of animals per sex per dose:

3 animals per dose.

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Body weights were measured on Day 1, 8 and 15. Clinical observations were recorded daily.
- Necropsy of survivors performed: yes

Statistics:

No statistical analysis was performed.

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No Mortality occurred.

Clinical signs:

other: Hunched posture and/or uncoordinated movements were noted in all animals on Day 1. In the first set of animals, red staining of the back was observed on Day 1 and red faeces were observed between Days 2 and 4. These findings were considered to be related

Gross pathology:

No abnormalities were found at macroscopic post mortem examination of the animals.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The oral LD50 value of R507-2 in Wistar rats was established to exceed 2000 mg/kg body weight.

According to the OECD 423 test guideline, the LD50 cut-off value was considered to exceed 5000 mg/kg body weight.

Based on these results, R507-2 does not have to be classified and has no obligatory labelling requirement for oral toxicity according to the GHS of Classification and labelling of Chemicals of the United nations (2004) and EC criteria for classification and labelling (1272/2008)

Executive summary:

R507 -2 was administered by oral gavage to two subsequent groups of three female Wistar rats at 2000 mg/kg body weight. Animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed after terminal sacrifice (Day 15)

No Mortality occurred.

Hunched posture and/or uncoordinated movements were noted in all animals on Day 1. In the first set of animals, red staining of the back was observed on Day 1 and red faeces were observed between Days 2 and 4. These findings were considered to be related to staining properties of the test substance and to be of no toxicological significance.

The body weight gain shown by animals over the study period was considered to be normal.

he oral LD50 value of R507-2 in Wistar rats was established to exceed 2000mg/kg body weight.

According to the OECD 423 test guideline, the LD50 cut-off value was considered to exceed 5000 mg/kg body weight.

Based on these results, R507-2 does not have to be classified and has no obligatory labelling requirement for oral toxicity according to the GHS of Classification and labelling of Chemicals of the United nations (2004) and EC criteria for classification and labelling (1272/2008).