Disodium [2,4-dihydro-4-[(2-hydroxy-5-nitrophenyl)azo]-5-methyl-2-phenyl-3H-pyrazol-3-onato(2-)][3-hydroxy-4-[(2-hydroxy-1-naphthyl)azo]-7-nitronaphthalene-1-sulphonato(3-)]chromate(2-)

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

October from 2nd to 17th, 1979

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: Test procedures cannot be subsumed under a testing guideline, nevertheless are well documented and scientifically acceptable. The test substance purity is unknown.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1979

Report date:

1979

Materials and methods

Principles of method if other than guideline:

Five male and five female rats were placed in a 435 litre stainless steel chamber with continuous air flow. The test material was introduced into a distilling flask at a constant rate by use of a Harvard pump. The vapours generated were introduced into the air stream. The dosage amount was calculated from the air flow and the amount of liquid material used. The animals were observed hourly during dosing and as late in the day as possible and then once daily for days 1-14. Mortality, toxicity and pharmacological effects were recorded. At 14 days the survivors were sacrificed. All animals were examined for gross pathology.

GLP compliance:

no

Remarks:

pre GLP

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Disodium [2,4-dihydro-4-[(2-hydroxy-5-nitrophenyl)azo]-5-methyl-2-phenyl-3H-pyrazol-3-onato(2-)][3-hydroxy-4-[(2-hydroxy-1-naphthyl)azo]-7-nitronaphthalene-1-sulphonato(3-)]chromate(2-)

EC Number:

274-490-1

EC Name:

Disodium [2,4-dihydro-4-[(2-hydroxy-5-nitrophenyl)azo]-5-methyl-2-phenyl-3H-pyrazol-3-onato(2-)][3-hydroxy-4-[(2-hydroxy-1-naphthyl)azo]-7-nitronaphthalene-1-sulphonato(3-)]chromate(2-)

Cas Number:

70236-60-1

Molecular formula:

C36H21CrN8O11S.2Na

IUPAC Name:

disodium [2,4-dihydro-4-[(2-hydroxy-5-nitrophenyl)azo]-5-methyl-2-phenyl-3H-pyrazol-3-onato(2-)][3-hydroxy-4-[(2-hydroxy-1-naphthyl)azo]-7-nitronaphthalene-1-sulphonato(3-)]chromate(2-)-

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: supplier Ace Animals.
- Age at study initiation: at least 8 weeks old when received.
- Weight at study initiation: 225-274 g.
- Housing: housed 5/cage in suspended wire mesh cages (20" x 10" x 7"), except during dosing when they were individually housed.
- Diet: ad libitum, Fresh Purina rat chow.
- Water: ad libitum.
- Acclimation period: rats were equilibrated for at least one week in the test laboratory.

Apparently healthy rats were selected for the test.

ENVIRONMENTAL CONDITIONS
- Temperature: maintained at 20 - 21 °C.
The animal room, reserved exclusively for rabbits on acute tests, was kept clean in accordance with the standards of AAALAC of which the test laboratory is an approved member.

Administration / exposure

Route of administration:

inhalation: vapour

Type of inhalation exposure:

whole body

Vehicle:

air

Details on inhalation exposure:

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Total Volume of Air: 2175 litres/minute.
- Material Used: 6 ml.
- Exposure chamber volume: rats were placed in a 435 litre stainless steel chamber with continuous air flow.
- Test material administration: the test material was introduced into a distilling flask at a constant rate by use of a Harvard pump. Vapours generated were introduced into the air stream.
- Amount: the dosage amount was calculated from the air flow and the amount of liquid material used.

Duration of exposure:

ca. 4 h

Concentrations:

Nominal Concentration: .013 mg/l.

No. of animals per sex per dose:

Five male and five female rats.

Details on study design:

- Duration of observation period following administration: the animals were observed hourly during dosing and as late in the day as possible and then once daily for Days 1-14.
- Frequency of observations and weighing: body weights were recorded pretest (Day 0) and on Days 7 & 14.
- Observation: mortality, toxicity and pharmacological effects were recorded.
- Necropsy of survivors performed: at 14 days the survivors were sacrificed.
- Other examinations performed: all animals were examined for gross pathology.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 0.013 mg/L air

Based on:

test mat.

Exp. duration:

4 h

Mortality:

0/5 males-0/5 females

Clinical signs:

other: Animal #1 exhibited chromorhinorrhea on Day 1. Animal #2 exhibited chromorhinorrhea on Days 1, 2, 9 thru 12. Animal #3 exhibited chromorhinorrhea on Day 1. Animal #4 exhibited chromodacryorrhea on Day 2, 12 & 13 and ptosis on Day 14. At all other observa

Body weight:

Normal body weight changes were noted.

Gross pathology:

All animals were normal.

Any other information on results incl. tables

BODY WEIGHTS - g

An. # & Sex	Day 0	Day 7	Day 14
1-M	274	313	359
2-M	250	287	327
3-M	269	312	357
4-M	268	324	376
5-M	258	305	341
6-F	227	237	252
7-F	227	235	248
8-F	226	244	265
9-F	228	229	241
10-F	225	228	246

Applicant's summary and conclusion

Interpretation of results:

other: not assessable under the CLP Regulation (EC 1272/2008) criteria

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

The test material is not toxic at a nominal concentration of .013 mg/litres.

Executive summary:

Method

Five male and five female rats were placed in a 435 litre stainless steel chamber with continuous air flow. The test material was introduced into a distilling flask at a constant rate by use of a Harvard pump. The vapours generated were introduced into the air stream. The dosage amount was calculated from the air flow and the amount of liquid material used. The animals were observed hourly during dosing and as late in the day as possible and then once daily for days 1-14. Mortality, toxicity and pharmacological effects were recorded. At 14 days the survivors were sacrificed. All animals were examined for gross pathology.

Result

All animals survived this test in generally good health. Normal body weight changes were noted. All animals were normal at necropsy.

The test material is not toxic at a nominal concentration of 0.013 mg/litres.