1,3-Benzenediamine, coupled with diazotized m-phenylenediamine, acetates

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

08. Feb. 1978 - 17. Mar. 1978

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Comparable to guideline studies with acceptable restrictions performed on analogue substance 1

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1979

Report date:

1979

Materials and methods

Principles of method if other than guideline:

BASF-Test. In principle, the methods described in OECD Guideline 401 were used.5 rats per sex and dose were treated simultaneously by gavage with preparations of the test substance in water. Group-wise documentation of clinical signs was performed over the 7 day study period. The clinical signs and findings were reported in summary form. On the basis of the observed lethality, the LD50 value was estimated or determined using a graphical evaluation of the dose response curve on probability paper.

GLP compliance:

no

Test type:

standard acute method

Test material

Test material information

Constituent 1

Reference substance name:

Trisodium bis[3-hydroxy-4-[(2-hydroxy-1-naphthyl)azo]-7-nitronaphthalene-1-sulphonato(3-)]chromate(3-)

EC Number:

260-906-9

EC Name:

Trisodium bis[3-hydroxy-4-[(2-hydroxy-1-naphthyl)azo]-7-nitronaphthalene-1-sulphonato(3-)]chromate(3-)

Cas Number:

57693-14-8

Molecular formula:

C40H20CrN6O14S2.3Na

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS- Weight at study initiation: male: 210 (mean), female: 160 (mean)

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Details on oral exposure:

VEHICLE- Concentration in vehicle: 5000 mg/kg: 50%3160 mg/kg: 31.6%2150 mg/kg: 21.5%1470 mg/kg: 14.7%

Doses:

5000mg/kg, 3160 mg/kg, 2150 mg/kg, 1470 mg/kg

No. of animals per sex per dose:

5

Details on study design:

- Duration of observation period following administration: 14 days - Frequency of observations: daily- Necropsy of survivors performed: yes- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

ca. 3 800 mg/kg bw

Mortality:

5000 mg/kg: 1 male and 1 female died within 5 days, 1 male and 3 females died within 6 days and 1 male and 1 female died on day 7.3160 mg/kg: 1 male died within day 3 and 1 within day 6. 1 female died on day 7.2150 mg/kg: No mortality was observed.1470 mg/kg: 1 female died within 4 days.

Clinical signs:

other: Poor general state in the 1st week of the study. Occurrence of death and loss of weight at the end of the 1st week of the study. 5000 mg/kg: Immediately after the application: apathy, irregular respiration, tumbling, spastic gait, discoloured urine (orang

Gross pathology:

Animals that died spontaneously:5000 mg/kg: Animals that died within 2 days: Heart: acute dilatation on the right; acute congestive hyperemia; adipose tissue/muscles: stained brown-yellow; intestine: single cases of a state indicative of preceding diarrhea. Animals that died within 4 days: intestine: dark brown contents; liver, kidneys, heart and lung: dark complexion, peritoneum and subcutis: stained brown-yellow. Animals that died within 6 days: cadaverous, probably overstaining of organs.3160 mg/kg: animals that died within 3 days: Heart: acute dilatation on the right; acute congestive hyperemia; adipose tissue/muscles: stained orange; animals that died within 6 days: conspicuously grey musculature; lung: wet, fleshy, hyperemia; liver: despite blood-filled conspicuous centrilobular pattern visible. Animals that died within 7 days: heart: dilatation of the ventricle; congestive hyperemia; muscles: despite cadaverous conditions grey-yellow staining observable.Sacrificed animals:5000 mg/kg: Kidneys: conspicuously dark.3160, 2150 and 1470 mg/kg: No abnormalities were observed.

Any other information on results incl. tables

Mortality:

Dose: mg/kg	gender	1h	24h	48h	7 days	14 days
5000	Male	0/5	0/5	0/5	3/5	3/5
5000	Female	0/5	0/5	0/5	5/5	5/5
3160	Male	0/5	0/5	0/5	2/5	2/5
3160	Female	0/5	0/5	0/5	1/5	1/5
2150	Male	0/5	0/5	0/5	0/5	0/5
2150	Female	0/5	0/5	0/5	0/5	0/5
1470	Male	0/5	0/5	0/5	0/5	0/5
1470	Female	0/5	0/5	0/5	1/5	1/5

Weight in g (mean):

Dose: mg/kg	gender	0 days	2 days	7 days	13 days
5000	Male	210	215	180	228
5000	Female	160	162	-	-
3160	Male	210	218	184	249
3160	Female	180	180	162	208
2150	Male	210	208	234	268
2150	Female	180	173	185	217
1470	Male	170	195	216	253
1470	Female	180	176	191	213

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated informationCriteria used for interpretation of results: EU

Conclusions:

The analogue substance 1 was tested for acute toxicity oral rats following a method similar to OECD401. Under the experimental conditions the substance showed LC50 ca 3800 mg/kg bw /day.

Executive summary:

The analogue substance 1 was tested for acute toxicity oral rats following a method similar to OECD401. The doses were 5000, 3160, 2150 and 1470 mg/kg bw /day by gavage for 5 animals/dose. Under the experimental conditions the substance showed LC50 ca 3800 mg/kg bw /day.