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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
May 16 - June 12, 2006
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study has been performed according to OECD guidelines and according to GLP principles.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2006
Report date:
2006

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)
Deviations:
no
GLP compliance:
yes
Test type:
up-and-down procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Color/form: Yellow powder
Chemical family: azo pigment
Storage conditions: ambient temperature (15-30°C)

Test animals

Species:
rat
Strain:
other: CD [Crl:CD (SD)BR]
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Canada, Montreal, Quebec
- Age at study initiation: approx. 10-11 weeks
- Weight at study initiation: 200-300 g before fasting. The weight variation in animals at the start of the study did not exceed +/- 20% of the mean weight.
- Fasting period before study: over-night
- Housing: individually housed in separate quarters in solid bottom cages.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25 (target range)
- Humidity (%): 30-70 (target range)
- Air changes (per hr): not indicated
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: Mineral Oil USP
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 0.05 g/mL
- Amount of vehicle (if gavage): two times 20 mL, one dose in the morning and the second dose 6 hours later.
- Justification for choice of vehicle: not indicated

MAXIMUM DOSE VOLUME APPLIED: 20 mL
Doses:
2000 mg/kg
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Observations: once during the first 30 min after dosing and periodically during the first 48 hours after dosing. Thereafter once daily.
Body weight: prior to tests article administration, day 7, 13 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs
Statistics:
For calculation of LD50, results were entered into the Acute Oral Toxicity statistical program, v.1.0.

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
No mortality observed.
Clinical signs:
No clinical signs observed.
Body weight:
Mean body weight gain was 32.5 +/- 5.9 g which is considered normal.
Gross pathology:
No findings.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute oral LD50 in rats was found to be in excess of 2000 mg/kg. Therefore, the test article is considered not to present a significant acute toxic risk if swallowed.