2,4-bis(((2-(dimethylammonio)ethyloxy)carbonyl)phen-2-ylazo)benzene-1,3-diolbis(methanesulfonate)

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

no

Test material

Reference

Name:

Unnamed

Type:

Constituent

Details on test material:

- Name of test material (as cited in study report): Basazol Gelb 8511
- Physical state: powder
- Analytical purity: 96%
- Lot/batch No.: 6123,V. 6781

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: R. K. THOMAE GMBH, D-7950 BIBERACH, FRG
- Weight at study initiation: male: 186g; female: 176g
- Fasting period before study: the animals were given no feed about 16 hours before administration, but water was available ad libitum.
- Housing: stainless steel wird mesh cages
- Diet: KLIBA-Labordieat 343
- Water: tap water ad libitum
- Acclimation period: for at least 1 week


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24°C
- Humidity (%): 30-70 %
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

olive oil

Doses:

464, 1000, 2000 and 2200 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: several times on the day of administration; at least once each workday
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 200 mg/kg bw

Effect levels 2

Sex:

male

Dose descriptor:

LD50

Effect level:

> 2 200 mg/kg bw

Effect levels 3

Sex:

female

Dose descriptor:

LD50

Effect level:

ca. 2 000 mg/kg bw

Mortality:

all doses: no male animal died
2000 mg/kg: 3 females died on day 1
2200 mg/kg: 2 females died after day 1 and 1 female on the second day

Clinical signs:

dyspnoea, apathy, staggering, piloerection, spastic gait, sheared fur, diarrhea, discoloured redbrown feces, discoloured orange urine

Gross pathology:

Animals that died: 2.000 mg/kg + 2.200 mg/kg, 3 females: General congestion.
2.000 mg/kg, 3 females: Gastrointestinal tract: filled with test substance; 2.200 mg/kg, 1 female: Stomach/small intestines: mucosa discoloured due to test substance. Contents discoloured. 2.200 mg/kg, 2 females: Glandular stomach: discoloured due to test substance. Intestines: contents discoloured, liquid; further diagnosis not possible (autolysis)
Sacrificed animals:
464 + 1.000mg/kg (5 males and 5 females), 2.000 + 2.200mg/kg (5 males and 2 females):
No pathologic findings noted.

Applicant's summary and conclusion

Interpretation of results:

harmful

Remarks:

Migrated information Criteria used for interpretation of results: EU