Sodium 1-amino-4-[[3-[(benzoylamino)methyl]-2,4,6-trimethylphenyl]amino]-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

From July 19 to August 2, 1979

Reliability:

4 (not assignable)

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:

1979

Report date:

1979

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: standards of AAALAC 16 CFR 1500.3

Principles of method if other than guideline:

Similar to OECD guideline 402 with substancial deviation related to number of animals used.

GLP compliance:

no

Remarks:

pre GLP

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Sodium 1-amino-4-[[3-[(benzoylamino)methyl]-2,4,6-trimethylphenyl]amino]-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate

EC Number:

267-224-0

EC Name:

Sodium 1-amino-4-[[3-[(benzoylamino)methyl]-2,4,6-trimethylphenyl]amino]-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate

Cas Number:

67827-60-5

Molecular formula:

C31H26N3O6S.Na

IUPAC Name:

sodium 1-amino-4-({3-[(benzoylamino)methyl]-2,4,6-trimethylphenyl}amino)-9,10-dioxo-9,10-dihydroanthracene-2-sulfonate

Test material form:

not specified

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Ace Animals
- Age at study initiation: at least 8 weeks old when received.
- Weight at study initiation: 2.3 - 2.6 Kg.
- Housing: suspended wire mesh cages (30" x 18" x 18").
- Diet: Fresh Purina rabbit chow ad libitum.
- Water: ad libitum.
- Acclimation period: at least one week.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 21°C

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

not specified

Details on dermal exposure:

TEST SITE
- Area of exposure: 200 square cm.
- % coverage: 10%
- Type of wrap if used: gauze patches.

REMOVAL OF TEST SUBSTANCE
- Washing: exposure site washed with warm tap water.
- Time after start of exposure: 24 hours.

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2.0 g/Kg.

Duration of exposure:

24 hours

Doses:

2.0 g/Kg

No. of animals per sex per dose:

2 per sex per dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily for 14 days for signs of toxicity, pharmacological effects and mortality. Body weights were recorded pretest and in the survivors at 7 and 14 days.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathology.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

All animals survived at a limit dose of 2.0 g/Kg

Clinical signs:

other: very slight edema was noted in all animals at 24 h.

Any other information on results incl. tables

Toxic Signs:

All animals appeared normal at all times.

 

Necropsy observations:

All animals were normal during the observation period.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

LD50 > 2000 mg/Kg bw

Executive summary:

Method:

Standards of AAALAC 16 CFR 1500.3. Similar to OECD guideline 402 with substancial deviation related to the number of animals used.

 

Observation:

All animals survived this test in good health. Erythema scores could not be determined at 24 hours. All other erythema scores were zero. Very slight edema was noted at 24 hours. All other edema scores were zero. All animals were normal at necropsy.

 

Results:

LD50 > 2000 mg/Kg bw