Sodium 6-amino-5-[[2-[(cyclohexylmethylamino)sulphonyl]phenyl]azo]-4-hydroxynaphthalene-2-sulphonate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

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

Report date:

1979

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Sodium 6-amino-5-[[2-[(cyclohexylmethylamino)sulphonyl]phenyl]azo]-4-hydroxynaphthalene-2-sulphonate

EC Number:

251-257-2

EC Name:

Sodium 6-amino-5-[[2-[(cyclohexylmethylamino)sulphonyl]phenyl]azo]-4-hydroxynaphthalene-2-sulphonate

Cas Number:

32846-21-2

Molecular formula:

C23H26N4O6S2.Na

IUPAC Name:

sodium 6-amino-5-({2-[cyclohexyl(methyl)sulfamoyl]phenyl}diazenyl)-4-hydroxynaphthalene-2-sulfonate

Specific details on test material used for the study:

Sample Name : Tectilon Red 2B KWL
Product # : 01-135303-100-0
Batch # : E 525, DCT #80220
Material received : 9/25/78

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

New Zealand White rabbits approximately 8 to 11 weeks of age were, received in good health from our local supplier and remained in good health during the equilibration period in this laboratory. The rabbits were equilibrated for at least 7 days. The rabbits were individually housed in elevated wire mesh cages in temperature-controlled rooms reserved exclusively for rabbits on acute tests.
Each animal was identified by a uniquely numbered metal tag affixed to its ear. Purina Rabbit Chow and water from bottles were available ad libitum.

Administration / exposure

Type of coverage:

occlusive

Vehicle:

water

Remarks:

Red Powder-used as 50 % weight/volume suspension in distilled water

Details on dermal exposure:

Twenty-four hours prior to dosing the backs of the rabbits were clipped free of fur with an Oster ANG-RA clipper head designed specifically for clipping rabbits. The rabbits were returned to their cages overnight. Just prior to dosing, the backs of even-numbered rabbits were abraded with a 21-gauge bent tip needle. The abrasions, made every 2 to 3 cm longitudinally, scratched the stratum corneum, but did not disturb the derma or produce bleeding.

The test material was applied to the backs of two male and two female rabbits at a dose of 2000 mg/kg. The test site was covered with gauze and the trunk was wrapped with impervious material for 24 hours. Following removal of the binder at 24 hours, the test site was washed with warm tap water. One hour after washing, the test sites were graded for skin irritation. Skin sites were read again at 7 and 14 days.

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

2 males and 2 females

Control animals:

no

Details on study design:

Body weights were recorded pretest and at 7 and 14 days. The rabbits were observed daily for 14 days for signs of toxicity and mortality. Necropsies were performed on all rabbits.

Statistics:

None

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

One (animal #4) out of the 4 animals was found dead on day 8.

Clinical signs:

other: Yellow nasal discharge - Animal #2, days 4-6, 11-13 Mucus in stool - Animal #4, days 3-6 Diarrhea - Animal #4, days 3-7 Ptosis - Animal #4, days 6 & 7 Lethargy - Animal #4, day

Gross pathology:

Animal #1 and 3 - No gross pathological observations.
Animal #2 : yellow exudate, nose/mouth; dark areas on lungs.
Animal #4 - yellow areas on intestines; red areas on stomach; mottled liver; dark lungs; mottled and pale kidney, dark and small spleen.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The acute dermal LD50 was found to be greater than 2000 mg/kg bw.

Executive summary:

FAT 20003 was tested for acute dermal toxicity potential (LD50) using methodology similar to OECD Guideline 402. The test substance was applied to back of two male and two female rabbits at a dose of 2000 mg/kg bw (1 intact and 1 abraded animal/ sex/ group). The test site was covered with gauze and trunk was wrapped with impervious material for 24 hours. After patch removal, animals were observed for 14 days for mortality, clinical signs and changes in bodyweight. They were submitted at random to a necropsy whenever they died, survivors at the end of the observation period. One animal (#4) with abraded skin was found dead on day 8. No other mortality was observed. Hence, the acute dermal LD50 was found to be greater than 2000 mg/kg bw.