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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1975
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report date:
1990

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
not applicable
Principles of method if other than guideline:
Acute toxicological investigations were conducted after oral administration of 5000 mg/kg MACROLEX Red 5B to 10 male Wistar rats.
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
3-methyl-6-[(4-methylphenyl)amino]-3H-naphthol[1,2,3-de]quinolone-2,7-dione
Cas Number:
81-39-0
Molecular formula:
C24H18N2O2
IUPAC Name:
3-methyl-6-[(4-methylphenyl)amino]-3H-naphthol[1,2,3-de]quinolone-2,7-dione
Test material form:
solid: particulate/powder
Specific details on test material used for the study:
physical state: solid
Appearance: red powder

Test animals

Species:
rat
Strain:
Wistar
Sex:
male
Details on test animals or test system and environmental conditions:
The rats were housed in groups of 5 under conventional conditions in Makrolon® Type-III cages on low-dust wood granules (supplier: Firma Bogner, Solingen) at a room temperature of 22 ± 2 •c, with artificial lighting from 6 a.m. to 6 p.m., relative humidity of about 50 ± 10% and approximately ten air changes per hour.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
polyethylene glycol
Remarks:
The substance was suspended in Lutrol (Polyethylene glykol 400) at room temperature on a magnetic stirrer.
Details on oral exposure:
The substance was suspended in Lutrol (Polyethylene glykol 400) at room temperature on a magnetic stirrer. It was then administered intragastrically to 10 male animals each by way of a rigid metal gavage at a constant application volume of 20 ml/kg body weight. The test substance was formulated in the application medium immediately before administration.
Doses:
5000 mg/kg
No. of animals per sex per dose:
10
Control animals:
no
Details on study design:
The animals were inspected several times on the day of administration, and twice daily during the following 14-day observation period (once on weekends and bank holidays). During
inspections, the type, onset, duration, and intensity of clinical signs were recorded and any dead animals were removed. The time of deat of the deceased was documented.

The animals were weighed before administration (day 0) and at the end of the observation period. The application volume for each individual animal was based on its body weight just before application.
Statistics:
not applied

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
discriminating dose
Effect level:
5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
not determinable due to absence of adverse toxic effects
Mortality:
noe deaths
Clinical signs:
Aftersingle administration of 5000 mg/kg MACROLEX Red 5B no clinical signs were observed.
Body weight:
Growth was not retarded
Gross pathology:
no noticeable gross pathological findings
Other findings:
no data

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Executive summary:

Acute toxicological investigations were conducted in an old study after oral administration of Macrolex Red 5B to male Wistar rats.

After single administration of 5000 mg/kg no clinical systemic poisoning were observed. No deaths occurred. The male rats sacrificed at the end of the study did not show any noticeable gross pathological findings.