N-(4-{[3-(dimethylamino)propyl]sulfamoyl}phenyl)-2-[(2-methoxy-4-nitrophenyl)diazenyl]-3-oxobutanamide

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2009

Report date:

2009

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1200 (Acute Dermal Toxicity)

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

other: JMAFF Nousan 8147 2-1-2

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

N-(4-{[3-(dimethylamino)propyl]sulfamoyl}phenyl)-2-[(2-methoxy-4-nitrophenyl)diazenyl]-3-oxobutanamide

EC Number:

700-222-4

Cas Number:

1065519-44-9

Molecular formula:

C22H28N6O7S

IUPAC Name:

N-(4-{[3-(dimethylamino)propyl]sulfamoyl}phenyl)-2-[(2-methoxy-4-nitrophenyl)diazenyl]-3-oxobutanamide

Constituent 2

Reference substance name:

No. 408 Yellow

IUPAC Name:

No. 408 Yellow

Details on test material:

- Name of test material (as cited in study report): No. 408 Yellow
- Physical state: yellow powder
- Analytical purity: 98.6%
- Purity test date: 07 November 2008
- Lot/batch No.: 081105-1
- Expiration date of the lot/batch: 04 November 2009
- Stability under test conditions:
- Storage condition of test material: room temperature, dark, sealed container
- Other: Source: TOYO INK MFG. CO. LTD.

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan UK Ltd, Bicester
- Age at study initiation: 8 - 12 weeks
- Weight at study initiation: males 148 - 278 g; females 186 - 221 g
- Fasting period before study: not necessary
- Housing: individually from day -1 to 3, 5/sex/group from day 3 until end of study
- Diet (e.g. ad libitum): SQC(E) Rat and Mouse Diet No. 1, Special Diets Services Ltd, Witham, UK, ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 8 to 21 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25
- Humidity (%): 40 - 70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

water

Details on dermal exposure:

TEST SITE
- Area of exposure: dorsum
- % coverage: at least 10% of the total body
- Type of wrap if used: A dense gauze patch was placed over the treated skin and retained in place by an elasticated, open-weave, adhesive compression bandage. This was wrapped securely around the torso of the animal. The dressing was considered to be semi-occlusive.


REMOVAL OF TEST SUBSTANCE
- Washing (if done): The dermal test site of each rat was lightly brushed clean of any solid residues and swabbed with water-moistened cotton wool.
- Time after start of exposure: 24 h


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): Individual dose weights (mg) were calculated from the body weight of the rats on the morning of dosing
- For solids, paste formed: yes

Duration of exposure:

24 hours

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

5 (including 1 each of preliminary test)

Control animals:

no

Details on study design:

- Duration of observation period following administration: 15 days
- Frequency of observations and weighing: Clinical signs were recorded immediately post-dose, at approximately 15 and 30 minutes post-dose, hourly between 1 and 4 hours post-dose (inclusive), twice daily on days 2, 3 and 4 and once daily from day 5 to 15; weighing was performed on day -1 (day before dosing) and on days 1, 4, 8 and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Statistics:

not necessary

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Mortality:

No mortality occurred.

Clinical signs:

No clinical signs observed.

Body weight:

All rats gained weight during the first and second week.

Gross pathology:

Pale, red or dark foci on the lungs and pale kidneys.

Other findings:

- Other observations: Dermal reactions noted were very slight to well-defined erythema noted in four males and one female on Day 2 with very slight erythema noted in one male and one female on Day 3.

Any other information on results incl. tables

Conclusion:

The acute median lethal dermal dose of No. 408 Yellow to rats was found to exceed 5000 mg/kg.

The test material was considered to have no significant acute toxic risk in respect of its acute dermal toxicity and did not meet the criteria for classification according to Commission Directive 2001/59/EC. No symbol and risk phrase are required.