Calcium 3-hydroxy-4-[(1-sulphonato-2-naphthyl)azo]-2-naphthoate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1974

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Non-GLP, non-guideline study, predates implementation of GLP and/or development of study guidelines, restrictions in design and/or reporting but otherwise adequate for assessment.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1974

Report date:

1974

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

Remarks:

body weights not recorded. Highest dose 5000 mg/kg bw

GLP compliance:

no

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Calcium 3-hydroxy-4-[(1-sulphonato-2-naphthyl)azo]-2-naphthoate

EC Number:

229-142-3

EC Name:

Calcium 3-hydroxy-4-[(1-sulphonato-2-naphthyl)azo]-2-naphthoate

Cas Number:

6417-83-0

Molecular formula:

C21H12N2O6S.Ca

IUPAC Name:

calcium 3-hydroxy-4-[(1-sulfonato-2-naphthyl)diazenyl]-2-naphthoate

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: bred on premises
- Age at study initiation: 7-8 weeks
- Weight at study initiation: male 292g and female 201g
- Fasting period before study: 18 hours
- Housing: single
- Diet: commercial pelleted diet (Oakes Special Diet with added Vit. E) ad libitum
- Water: ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21±2
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: polyethyleneglycol/water 50:50

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 17%

MAXIMUM DOSE VOLUME APPLIED: 30 mL/kg

Doses:

5 g/kg

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: deaths and clinical signs

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

No deaths occurred.

Clinical signs:

other: No clinical symptoms were recorded.

Gross pathology:

At autopsy no changes caused by the test substance were seen.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Based on an acute oral toxicity study in rats, the oral LD50 of Compound TK 11736 (CAS 6417-83-0) was found to exceed 5000 mg/kg bw/day.

Executive summary:

In an acute oral toxicity study male and female Sprague-Dawley rats were administered the test substance at a dose level of 5000 mg/kg bw (5 animals per sex per dose group) by oral gavage. Polyethylene glycol/water (50:50) was used as vehicle. Dosing was followed by a 14 day observation period. No clinical symptoms were recorded and no deaths occurred. At autopsy no changes were seen. Therefore the LD50 of Compound TK 11736 (CAS 6417-83-0) is > 5000 mg/kg bw.