[No public or meaningful name is available]

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From July 21 to August 11, 2005

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2005

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

adopted 17 December 2001

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Direct Blue 267

IUPAC Name:

Direct Blue 267

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River (UK) Ltd, Margate, Kent, UK.
- Females: animals were nulliparous and non-pregnant.
- Age at study initiation: eight to twelve weeks of age.
- Weight at study initiation: fell within an interval of ± 20 % of the mean initial bodyweight of the first treated group.
- Fasting period before study: overnight fast immediately before dosing and for approximately three to four hours after dosing.
- Housing: animals were housed in groups of three III suspended solid-floor polypropylene cages furnished with woodflakes.
- Diet: certified rat and mouse diet (Code 5LF2) supplied by BCM IPS Limited, ad libitum.
- Water: drinking water, ad libitum.
- Acclimation period: at least five days.

ENVIRONMENTAL CONDITIONS
- Temperature: 19 to 25 °C
- Relative humidity: 30 to 70 %
- Air changes: 15 changes per hour.
- Photoperiod: lighting was controlled by a time switch to give twelve hours continuous light (06:00 to 18 :00) and twelve hours darkness.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

For the purpose of the study the test material was freshly prepared, as required, as a solution at the appropriate concentration in distilled water.

Sufficient time was allowed between each group to confirm the survival of the previously dosed animals.

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

3 rats × group

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: the animals were observed for deaths or overt signs of toxicity 30 min, 1, 2 and 4 hours after dosing and subsequently once daily for fourteen days.
- Frequency of weighing: individual bodyweights were recorded prior to dosing and seven and fourteen days after treatment.
- Necropsy of survivors performed: yes; animals were killed by cervical dislocation. All animals were subjected to gross pathological examination. This consisted of an external examination and opening of the abdominal and thoracic cavities for examination of major organs. The appearance of any macroscopic abnormalities was recorded. No tissues were retained.

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

not determinable due to absence of adverse toxic effects

Mortality:

There were no deaths.

Clinical signs:

There were no signs of systemic toxicity. Black faeces were noted in three animals one and two days after dosing.

Body weight:

All animals showed expected gains in bodyweight over the study period.

Gross pathology:

No abnormalities were noted at necropsy.

Applicant's summary and conclusion

Interpretation of results:

other: not classified, according to the CLP Regulation (EC) No 1272/2008

Conclusions:

LD50 (females) > 2000 mg/kg bw

Executive summary:

The study was performed to assess the acute oral toxicity of the test material following a single oral administration in the Sprague-Dawley CD strain rat. The method was designed to meet the requirements of the OECD guideline 423 and EU Method B1 tris Acute Toxicity (Oral) of Commission Directive 2004173/EC Method. A group of three fasted females was treated with the test material at a dose level of 2000 mg/kg bodyweight. This was followed by a further group of three fasted females at the same dose level.

The test material was administered orally as a solution in distilled water. Clinical signs and bodyweight development were monitored during the study. All animals were subjected to gross necropsy.

There were no deaths and there were no signs of systemic toxicity. All animals showed expected gains in bodyweight over the study period.

No abnormalities were noted at necropsy.

The acute oral median lethal dose (LD50) of the test material in the female Sprague-Dawley CD strain rat was estimated to be greater than 2000 mg/kg bodyweight.

Conclusion

LD50 (females) > 2000 mg/kg bw