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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report date:
1986

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Test type:
other: single dose acute toxicity study
Limit test:
no

Test material

Constituent 1
Reference substance name:
Reaction mass of 3-[(4-amino-6-bromo-5,8-dihydro-1-hydroxy-8-imino-5-oxo-2-naphtyl)amino]-N,N,N-trimethylanilinium chloride and 3-[(8-amino-dibromo-5-hydroxy-4-imino-1-oxo-1,4-dihydronaphthalenyl)amino]-N,N,N-trimethylbenzenaminium chloride and 3-[(bromo-1,4-dihydroxy-8-imino-5-oxo-5,8-dihydronaphthalenyl)amino]-N,N,N-trimethylbenzenaminium chloride
EC Number:
916-466-1
IUPAC Name:
Reaction mass of 3-[(4-amino-6-bromo-5,8-dihydro-1-hydroxy-8-imino-5-oxo-2-naphtyl)amino]-N,N,N-trimethylanilinium chloride and 3-[(8-amino-dibromo-5-hydroxy-4-imino-1-oxo-1,4-dihydronaphthalenyl)amino]-N,N,N-trimethylbenzenaminium chloride and 3-[(bromo-1,4-dihydroxy-8-imino-5-oxo-5,8-dihydronaphthalenyl)amino]-N,N,N-trimethylbenzenaminium chloride
Details on test material:
Identification : Arianor Steel Blue
Batch number : KS3993

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: distilled water
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
Five males and five females
Control animals:
no
Details on study design:
A group of ten rats (five males and five females) was treated at 2000 mg/kg bw. The test item was prepared at 20w/v% in distilled water and administered at a volume of 10mL/kg. Animals were observed soon after dosing then at frequent intervals for the remainder of day 1. On subsequent days the animals were observed at least twice per day. Clinical signs were recorded at each observation. All animals were observed for 14 days after dosing. The nature, severity, approximate time of onset and duration of each toxic sign and individual bodyweights of rats on days 1, 8 and 15 were recorded. All animals were sacrificed on day 15 and were subjected to a macroscopic post mortem examination.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
There were no mortalities following a single oral dose of the test item at 2000 mg/kg bw.
Clinical signs:
Signs of reaction to treatment observed in all rats shortly after dosing were pilo-erection, abnormal body carriage (hunched posture), abnormal gait (waddling) and increased salivation. Recovery as judged by external appearance and behaviour was apparently complete by day 3.
Body weight:
Bodyweight gains were recorded for all rats on days 8 and 15.
Gross pathology:
Terminal autopsy findings were normal.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute lethal oral dose to rats of the test item was found to be greater than 2000 mg/kg bw.
Executive summary:

The acute lethal oral dose to rats of the test item Basic Blue 99 was found to be greater than 2000 mg/kg bw in a study performed according to OECD guideline 401.