Disodium [N-(2-chlorophenyl)-2-[(2-hydroxy-5-nitrophenyl)azo]-3-oxobutyramidato(2-)][3-hydroxy-4-[(2-hydroxy-1-naphthyl)azo]-7-nitronaphthalene-1-sulphonato(3-)]chromate(2-)

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From September 28 to October 12, 1979

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1979

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

not specified

GLP compliance:

no

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Disodium [N-(2-chlorophenyl)-2-[(2-hydroxy-5-nitrophenyl)azo]-3-oxobutyramidato(2-)][3-hydroxy-4-[(2-hydroxy-1-naphthyl)azo]-7-nitronaphthalene-1-sulphonato(3-)]chromate(2-)

EC Number:

276-649-0

EC Name:

Disodium [N-(2-chlorophenyl)-2-[(2-hydroxy-5-nitrophenyl)azo]-3-oxobutyramidato(2-)][3-hydroxy-4-[(2-hydroxy-1-naphthyl)azo]-7-nitronaphthalene-1-sulphonato(3-)]chromate(2-)

Cas Number:

72403-66-8

Molecular formula:

C36H21ClCrN7Na2O12S

IUPAC Name:

disodium [N-(2-chlorophenyl)-2-[(2-hydroxy-5-nitrophenyl)azo]-3-oxobutyramidato(2-)][3-hydroxy-4-[(2-hydroxy-1-naphthyl)azo]-7-nitronaphthalene-1-sulphonato(3-)]chromate(2-)

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: Perfection Breeders, Ace Animals, Nicholas Hel f
- Age at study initiation: 9 weeks
- Weight at study initiation: from 2.2 to 3.7 kg
- Housing: housed 1/cage in suspended wire mesh cages (30" x 18" x 18")
- Diet (e.g. ad libitum): fresh Purina rabbit chow ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 1 week

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

Administration / exposure

Type of coverage:

occlusive

Vehicle:

not specified

Details on dermal exposure:

TEST SITE
- Area of exposure: 200 square cm
- % coverage: ca. 10%

REMOVAL OF TEST SUBSTANCE
- Washing: warm tap water

TEST MATERIAL
- Amount(s) applied: rabbit #1 applied 6.7 cc; rabbit #2 applied 4.3 cc; rabbit #3 applied 4.1 cc; rabbit #4 applied 4.0 cc
- Constant volume or concentration used: no

Duration of exposure:

24 hours

Doses:

2000 mg/kg

No. of animals per sex per dose:

2 animals per sex per dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: dermal reactions were scored at 25 hours, 7 and 14 days. 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 and 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:

No mortalities observed.

Clinical signs:

other: One animal had lethargy, ptosis, emaciation, diarrhea, adipsia, anorexia and few feces. See table 1.

Gross pathology:

At necropsy, three animals were normal and one animal had white nodules on the liver

Other findings:

- Other observations: 24 Hour erythema scores could not be calculated due to the color of the material. All other dermal scores at all other times were zero.

Any other information on results incl. tables

Table 1 – Toxic Signs

ANIMAL # & SEX	HOUR	DAY
	0	1	2	3	4	5	6	7	8	9	10	11	12	13	14
1-M													2	2	2
2-M
3-F				BQD	BD	BX	BX	BXQ	BXQ	BXQ	BDQ	BDQ	BDQW	BQW USX	BQW USX
4-F

CODE:

B = lethargy

D = diarrhea

Q = ptosis

S = adipsia

U = anorexia

W = emaciation

X = few feces

2 = white nasal discharge

Applicant's summary and conclusion

Interpretation of results:

other: CLP criteria not met

Conclusions:

LD50 > 2000 g/kg bw.

Executive summary:

Method

The study was performed following a procedure similar to OECD 402.

New Zealand White rabbits, at least 8 weeks old, were equilibrated for at least one week. The animals were housed 1 per cage in suspended wire mesh cages (30" x 18" x 18"). The animal room was maintained at 20 - 21 °C and was kept clean in accordance with the standards of AAALAC.

24 hours prior to dosing, the fur was clipped from the backs of the animals. The clipped area was 200 square cm, approximately 10 %

of the body surface. Just prior to dosing, abrasions were made in one half of the rabbits. The abrasions, extending the length of the exposure site, scratched the stratum corneum but did not reach the derma or produce bleeding.

Two male and two female rabbits were dosed at 2000 mg/kg. The test material was applied once dermally to the prepared site under occlusive gauze patches. The test material was kept in contact with the skin for 24 hours, at which time the wrappings were removed. An estimate of the amount of material remaining was recorded. The exposure site was washed with warm tap water to remove excess material.

Dermal reactions were scored at 25 hours, 7 and 14 days by the Draize scoring system. The rabbits were observed 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.

Observations

All animals survived the test. At 14th day, the survivors were sacrificed. All animals were examined for gross pathology.

Results

LD50 > 2000 g/kg bw.