[[4-[[4-(anilino)phenyl][4-(phenylimino)-2,5-cyclohexadien-1-ylidene]methyl]phenyl]amino]benzenesulphonic acid

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:

other: old study without GLP, but fulfill basically scientific principles

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1976

Report date:

1976

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

not specified

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Alkali Blue GG (CP-1816)

IUPAC Name:

Alkali Blue GG (CP-1816)

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

Alkali Blue GG (CP-1816) was received from the Sherwin Williams company and evaluated for its oral toxicity in rats.

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

Ten albino Sprague-Dawley rats (5 male, 5 female) were obtained from Taconic Farms. The rats were housed five to a cage and fed Purina Laboratory Chow and water at ibiturn.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

not specified

Details on oral exposure:

Following a brief acclimation period, the rats were fasted overnight then gavaged with the test material at the rate of 5 gm/kg of body weight.

Doses:

5000 mg/kg of body weight

No. of animals per sex per dose:

5

Control animals:

not specified

Details on study design:

Ten albino Sprague-Dawley rats (5 male, 5 female) were obtained from Taconic Farms. The rats were housed five to a cage and fed Purina Laboratory Chow and water 1 ibiturn. Body weights were recorded at dosing and on Day 14. Observations were made frequently after dosing and daily until termination. Animals sacrificed at Day 14 were subjected to a gross examination of the viscera.

Statistics:

no data

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: No animals died during the 14-day observation period, No signs of toxicity were noted after administration. Body weight gain was good. No observations were noted at necropsy.

Mortality:

No animals died during the 14-day observation period.

Clinical signs:

No signs of toxicity were noted after administration.

Body weight:

Body weight gain was good.

Gross pathology:

No observations were noted at necropsy.

Other findings:

no data

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Based on the results given in this study, test article is considered non-toxic. LD 50(oral, rats) is estimated at greater than 5000 mg/kg of body weight.

Executive summary:

An acute oral toxicity study of test article was conducted in young albino rats. Ten Sprague-Dawley rats were exposed at the level of 5000 mg/kg of body weight. Body weights were recorded at dosing and on day 14. Observations were made frequently after dosing and daily until termination. Animals sacrificed at Day 14 were subjected to a gross examination of the viscera. Based on a 100% survival rate at 5000mg/kg of body weight, test article was considered as non-toxic. The LD50 would be estimated at greater than 5000 mg/kg of body weight.