Reaction mass of Chromate(1-), [N-[7-hydroxy-8-[(2-hydroxy-5-nitrophenyl)azo]-1-naphthalenyl]acetamidato(2-)][1-[(2-hydroxy-5-nitrophenyl)azo]-2-naphthalenolato(2-)]-, hydrogen, compd. with N-cyclohexylcyclohexanamine (1:1) and hydrogen bis[1-[(2-hydroxy-5-nitrophenyl)azo]-2-naphtholato(2-)]chromate(1-) , compound with dicyclohexylamine (1:1) and hydrogen bis[N-[7-hydroxy-8-[(2-hydroxy-5-nitrophenyl)azo]-1-naphthyl]acetamidato(2-)]chromate(1-) , compound with dicyclohexylamine (1:1)

Acute Toxicity: oral

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:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1972

Report date:

1972

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Reference substance 001

Cas Number:

12237-23-9

Test animals

Species:

rat

Strain:

other: RAI (outbred,SPF)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: between 110 and 1470 g
- Fasting period before study: overnight
- Housing: Groups of 5 in macrolon cages (size 3)
- Diet: Nafag standard diet, ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): room temperature of 22 ± 1 °C
- Humidity (%): 55 ± 5%
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Remarks:

0.5% CMC and tap water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 2.5%; 5%; 15%; 25%; 50%


MAXIMUM DOSE VOLUME APPLIED: 10000 mg/kg

Doses:

500; 1000; 3000; 5000; 10000 mg/kg

No. of animals per sex per dose:

3-5 males; 2-5 females

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 8 days
- Other examinations performed: clinical signs, body weight,organ weights

Statistics:

The LD50 was calculated by the method of Miller-Tainter (Proc. Soc. Exp. Biol. Med. 57, 261, 1944).

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

3 250 mg/kg bw

95% CL:

> 2 598 - < 3 902

Mortality:

- At dose of 500 mg/kg: no deaths
- At dose of 1000 mg/kg: no deaths
- At dose of 3000 mg/kg: 1/5 males; 2/5 females
- At dose of 5000 mg/kg: 5/5 males; 3/5 females
- At dose of 10000 mg/kg: 3/3 males; 2/2 females

Clinical signs:

other: - At dose of 500 mg/kg: skin and feces black stained - At dose of 1000 mg/kg: skin and feces black stained - At dose of 3000 mg/kg: ataxia, stiff movements, eyes, skin and feces black stained - At dose of 5000 mg/kg: ataxia, stiff movements, eyes, skin an

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met