N,N'-(2,5-dichloro-1,4-phenylene)bis[4-[[2-chloro-5-(trifluoromethyl)phenyl]azo]-3-hydroxynaphthalene-2-carboxamide]

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

(TS purity not specified; size of application area not reported; 4 animals used (without justification); abraded skin was treated in 2 animals)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1978

Report date:

1978

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

before 2017-10-09

Deviations:

yes

Remarks:

4 animals used (without justification); abraded skin was treated in 2 animals; size of application area not reported

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

N,N'-(2-chloro-1,4-phenylene)bis[4-[(2,5-dichlorophenyl)azo]-3-hydroxynaphthalene-2-carboxamide]

EC Number:

226-106-9

EC Name:

N,N'-(2-chloro-1,4-phenylene)bis[4-[(2,5-dichlorophenyl)azo]-3-hydroxynaphthalene-2-carboxamide]

Cas Number:

5280-78-4

Molecular formula:

C40H23Cl5N6O4

IUPAC Name:

N,N'-(2-chloro-1,4-phenylene)bis{4-[(2,5-dichlorophenyl)diazenyl]-3-hydroxy-2-naphthamide}

Test material form:

solid: particulate/powder

Details on test material:

- Physical state: red powder
- Analytical purity: no data

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: 8-11 weeks
- Weight at study initiation: 2.5-2.7 kg
- Housing: individually in elevated wire mesh cages
- Diet (e.g. ad libitum): Purina Rabbit Chow ad lib.
- Water (e.g. ad libitum): water from bottles ad lib.
- Acclimation period: at least 7 days
ENVIRONMENTAL CONDITIONS
Housing in temperature controlled rooms (no further details)

Administration / exposure

Type of coverage:

occlusive

Vehicle:

water

Details on dermal exposure:

TEST SITE
- Area of exposure: back, intact or abraded skin (each 2 animals; 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)
- % coverage: not reported (regarding the body weight of ca. 2500 mg and the formula BSA = 9.5 *
(body weight in g)exp(2/3), the test site should be > 180 cm2 for guideline conformity)
- Type of wrap if used: impervious material
REMOVAL OF TEST SUBSTANCE
- Washing (if done): warm tap water
TEST MATERIAL
- Concentration (if solution): 50% w/v suspension in distilled water
- Constant volume or concentration used: yes

Duration of exposure:

24 h

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

2

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations: once daily; weighing once weekly
- Necropsy of survivors performed: yes
- Other examinations performed: evaluation of local effects according to OECD Draize scheme after
25 hours, 7 and 14 days

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD0

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: Abrasion (2/4 animals) had no effect on local or systemic effects

Mortality:

none

Clinical signs:

other: in 1 animal (intact skin): Diarrhea, days 3 & 4 and 7 to 10; Abdomen bloated, days 4 to 7; An orexia, days 5 and 6; Adipsia, days 5 and 6; no fecal matter in pan day 5.

Gross pathology:

One animal had yellow exudate from nose/mouth and another had bloated intestines. No abnormal
findings in the other two animals (with abraded skin).

Other findings:

Neither erythema nor edema were observed.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met