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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

acute toxicity: oral
Type of information:
other: read across from analogue substance
Adequacy of study:
key study
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions

Data source

Reference Type:
study report

Materials and methods

Test guidelineopen allclose all
according to guideline
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
adopted 17 December 2001
according to 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:

Test material

Constituent 1
Reference substance name:
Direct Blue 267
Direct Blue 267

Test animals

Details on test animals or test system and environmental conditions:
- 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.

- 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
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.
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
Dose descriptor:
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
not determinable due to absence of adverse toxic effects
There were no deaths.
Clinical signs:
other: There were no signs of systemic toxicity. Black faeces were noted in three animals one and two days after dosing.
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
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.


LD50 (females) > 2000 mg/kg bw