Reaction mass of bis[3-[[4-[benzylmethylamino]phenyl]azo]-1,4-dimethyl-1H-1,2,4-triazolium] tetrachlorozincate(2-) and bis[5-[[4-[benzylmethylamino]phenyl]azo]-1,4-dimethyl-1H-1,2,4-triazolium] tetrachlorozincate(2-)

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1977/78

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1978

Report date:

1978

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: 16 CFR Part 1500 - HAZARDOUS SUBSTANCES AND ARTICLES; ADMINISTRATION AND ENFORCEMENT REGULATIONS

Deviations:

no

GLP compliance:

no

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Bis[5-[[4-[benzylmethylamino]phenyl]azo]-1,4-dimethyl-1H-1,2,4-triazolium] tetrachlorozincate(2-)

EC Number:

281-692-3

EC Name:

Bis[5-[[4-[benzylmethylamino]phenyl]azo]-1,4-dimethyl-1H-1,2,4-triazolium] tetrachlorozincate(2-)

Cas Number:

84012-52-2

Molecular formula:

C36H42Cl4N12Zn

IUPAC Name:

bis[5-({4-[benzyl(methyl)amino]phenyl}diazenyl)-1,4-dimethyl-4,5-dihydro-1H-1,2,4-triazol-1-ium] tetrachlorozincate(2-)

Constituent 2

Reference substance name:

Bis[3-[[4-[benzylmethylamino]phenyl]azo]-1,4-dimethyl-1H-1,2,4-triazolium] tetrachlorozincate(2-)

EC Number:

281-650-4

EC Name:

Bis[3-[[4-[benzylmethylamino]phenyl]azo]-1,4-dimethyl-1H-1,2,4-triazolium] tetrachlorozincate(2-)

Cas Number:

84000-94-2

Molecular formula:

C36H42Cl4N12Zn

IUPAC Name:

bis(3-[(E)-2-{4-[benzyl(methyl)amino]phenyl}diazen-1-yl]-1,4-dimethyl-1H-1,2,4-triazol-4-ium); tetrachlorozincdiuide

Test material form:

solid: particulate/powder

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: local supplier
- Age at study initiation: 8 to 11 weeks
- Housing: 1/cage in suspended wire mesh cages (30" x 1.8" x 18") in temperature controlled rooms
- Diet (e.g. ad libitum): Purina Rabbit Chow ad libitum
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: at least 7 days

Administration / exposure

Type of coverage:

occlusive

Vehicle:

water

Details on dermal exposure:

TEST SITE
- Area of exposure:200 square cm
- % coverage : 10% of the body surface.
- Type of wrap if used: gauze patches and impervious material

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The exposure site was washed with warm tap water
- Time after start of exposure: 24h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2.0 g/kg bw


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 one half of the 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 2.0 g/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 according to the attached scale. Skin sites were read again at 7 and 14 days. Body weights were recorded pretest and at 7 and 14 days. The rabbits were observed daily for 14 days for signs of toxicity or mortality. Necropsies were performed on all rabbits.

Duration of exposure:

The test material was kept in contact with the skin for 24 hours, at which time the wrappings were removed.

Doses:

2.0 g/kg bw

No. of animals per sex per dose:

2

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weigthing: 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, pharmcaological effects and mortality. Body weights were recorded pretest and in the survivors at 7 and 14 days.
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

no indication of skin irritation up to the relevant limit dose level

Mortality:

0/2 male
0/2 female

Clinical signs:

other: no systemic or local effects

Gross pathology:

Liver purple: 1/4
Lungs purple: 2/4
Kidney Mottled: 2/4

Applicant's summary and conclusion

Interpretation of results:

other: no dermal toxicity observed

Conclusions:

The test material is not toxic , as defined in 16 CFR 1500.3, at a dose level of 2.0 g/kg of body weight.

Executive summary:

2 males and 2 females New Zealand White rabbits were dosed at 2.0 g/kg of body weight. The substance was prepared at 50% w/v in distilled water. The test material was applied once dermally to the prepared site under gauze patche and was kept in contact with the skin for 24 hours. The exposure site was washed with warm tap water to remove excess material.

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. Animals were generally healthy throughout the 14 day test period. No erythema or edema were observed either on intact or abraded skin during the 14 days observation period. Necropsies of animals sacrificed on Day 14 revealed purple liver and lungs in one or two rabbits, respectively and mottled kidneys in two rabbits. There were no other abnormalities.

In conclusion, all animals survived this test at 2.0 g/kg of body weight and the test material is considered not toxic at this dose level.