4,4'-[1,3-phenylenebis(azo)]bisbenzene-1,3-diamine

Endpoint summary

Description of key information

LD50, oral, rat, (m/f) > 2698 mg/kg bw (BASF, 1979)

LC50, inhalation, rat (m/f) > 5610 mg/m3 (BASF, 1978)

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

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

Principles of method if other than guideline:

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

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)

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

Sex:

male/female

Dose descriptor:

LD50

Effect level:

ca. 3 800 mg/kg bw

Based on:

test mat.

Sex:

male/female

Dose descriptor:

LD50

Effect level:

ca. 2 698 mg/kg bw

Based on:

act. ingr.

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 (oran

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.

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

Interpretation of results:

not classified

Remarks:

Migrated information according to CLP Regulation Criteria 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 of tested material, i.e. 2698 mg/kg bw active ingredient.

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, i.e. 2698 mg/kg bw of active ingredient

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 698 mg/kg bw

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Type of information:

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

Adequacy of study:

key study

Study period:

19. Apr 1978 - 05. May 1978

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

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

Principles of method if other than guideline:

Inhalation Hazard Test: The test was performed equivalent or similar to the method described in H.F. Smyth et. al. Am. Ind. Hyg. Ass. 23, 95-107 (1962). Inhalation of an atmosphere enriched at room temperature with the dust of the test material by rats for 7 hours. The documentation of clinical signs was performed over a period of 7 days.

GLP compliance:

no

Test type:

other: Inhalation hazard test.

Limit test:

no

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: 185 g (mean), female: 221 g (mean)

Route of administration:

inhalation: dust

Type of inhalation exposure:

not specified

Vehicle:

air

Details on inhalation exposure:

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- pressure in air chamber: 1.013 bar

Analytical verification of test atmosphere concentrations:

no

Duration of exposure:

ca. 7 h

Concentrations:

7.91 mg/l (nominal)

No. of animals per sex per dose:

6

Control animals:

no

Details on study design:

- Duration of observation period following administration: 7 days
- Frequency of observations: daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 5.61 mg/L air

Based on:

act. ingr.

Exp. duration:

7 h

Mortality:

No mortality was observed.

Clinical signs:

other: 7 h post exposure occured irregular respiration, bloody nose discharge and scrubby fur. 6 days post exposure all animals were considered as normal.

Gross pathology:

No abnormalities were observed.

Interpretation of results:

not classified

Remarks:

Migrated information according to CLP Regulation Criteria used for interpretation of results: EU

Conclusions:

Analogue substance 1 was tested for inhalation toxicity on rat exposed to dust in a concentration of 5.61 mg/l of active ingredient for 7 hours. The animals of both sex have been observed for 7 days after exposure and the effects reported. No mortality was observed at the concentration of 5.61 mg/l.

Executive summary:

Analogue substance 1 was tested for inhalation toxicity on rat exposed to dust in a concentration of 5.61 mg/l of active ingredient for 7 hours. The animals of both sex have been observed for 7 days after exposure and the effects reported. No mortality was observed at the concentration of 5.61 mg/l.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LC50

Value:

5 610 mg/m³ air

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Valid in vivo data are available for the assessment of the acute toxicity of the test substance over two exposure patterns, oral and inhalation. In particular: inhalation exposure pattern is covered by a study on analogue substance 1 while oral toxicity is assessed by two studies, one on the substance itself, the other on analogue substance 1.

Acute toxicity oral.

Mortality was observed at the highest dose used in the oral test on analogue substance 1 (i.e. 2698 mg/kg bw > 2000 mg/kg bw limit dose for classification) after one week and it was not observed in the test performed on the substance itself, even though at a smaller concentration, i.e. LD50 (LD0) > 1120 mg/kg bw (recalculated based on the active ingredient). Even though the substance itself was tested at doses below the classification limits, no clinical adverse effects were observed during the whole test and gross patology did not show any substance related effect. Therefore the substance toxicity can be supposed very low. Based on the read across justification the value found for analogue substance 1 can be used for classification purposes.

Acute toxicity inhalation

No mortality was observed during the inhalation test at the concentration of LC50 (LC0)> 5610 mg/m3.

Based on the read across considerations and the testing results, Solvent Brown 41 is not considered toxic after single acute oral or inhalative exposure.

Justification for classification or non-classification

According to the CLP Regulation (EC n. 1272/2008), table 3.1.1, Acute toxicity hazard categories and acute toxicity estimates (ATE) defining the respective categories:

For Acute toxicity oral route:

Category 1: ATE <= 5 mg/kg bw

Category 2: 5 < ATE <= 50 mg/kg bw

Category 3: 50 < ATE <= 300 mg/kg bw

Category 4: 300 < ATE <= 2000 mg/kg bw

The LD50 of the test substance was determined to be 2698 mg/kg bw in the chosen reference test, therefore, the test substance is not classified for Acute toxicity by oral exposure.

For Acute toxicity inhalation route (mists, mg/l)

Category 1: ATE <= 0.05

Category 2: 0.05 < ATE <= 0.5

Category 3: 0.5 < ATE <= 1

Category 4: 1 < ATE <= 5

The LC50 of the test substance was determined to be 5610 mg/m3 (or 5.6 mg/l), therefore, the test substance is not classified for Acute toxicity by inhalation exposure.