N-(4-ethoxyphenyl)-3-hydroxy-4-[(2,4,5-trichlorophenyl)azo]naphthalene-2-carboxamide

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2012

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2012

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

1987

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

4-[[4-(aminocarbonyl)phenyl]azo]-N-(2-ethoxyphenyl)-3-hydroxynaphthalene-2-carboxamide

EC Number:

220-509-3

EC Name:

4-[[4-(aminocarbonyl)phenyl]azo]-N-(2-ethoxyphenyl)-3-hydroxynaphthalene-2-carboxamide

Cas Number:

2786-76-7

Molecular formula:

C26H22N4O4

IUPAC Name:

4-[(4-carbamoylphenyl)diazenyl]-N-(2-ethoxyphenyl)-3-hydroxy-2-naphthamide

Test material form:

solid: particulate/powder

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- lot/batch No.of test material: DEB2 152781 (Mi. 4014/2011)
- Expiration date of the lot/batch: 2021-06-12

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature
- Solubility and stability of the test substance in the solvent/vehicle:

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing:
- Final preparation of a solid: moistened solid

FORM AS APPLIED IN THE TEST : solid

Purity: 98,2 % w/w

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

Species/strain: healthy rats, WISTAR rats Cd: WI(Han) (full barrier)
Source: Charles River, 97633 Sulzfeld, Germany
Sex: male and female
Number of animals: 5 male and 5 female
Age at the beginning of the study: males: 8 - 9 weeks old females: 11 - 12 weeks old
Body weight on the day of administration: males: 227 - 245 g;females: 207 - 218 g.

The female animals were non-pregnant and nulliparous.

The animals were derived from a controlled full-barrier maintained breeding system
(SPF). According to Art. 9.2, No.7 of the German Act on Animal Welfare [6) the
animals were bred for experimental purposes.
Full barrier in an air-conditioned room
Temperature: 22 ± 3 °C
Relative humidity: 55 ± 10%
Artificial light, sequence being 12 hours light, 12 hours dark
Air change: lOx / hour
Free access to Altromin 1324 maintenance diet for rats and mice (lot no. 1114)
Free access to tap water, sulphur acidified to a pH value of approximately 2.8
(drinking water, municipal residue control, microbiological controls at regular
intervals)
The animals were kept individually in IVC cages, type III H, polysulphone cages on
Altromin saw fibre bedding (lot no. 110811)

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

water

Remarks:

test item was moistened, not suspended or dissolved

Details on dermal exposure:

TEST SITE
- Area of exposure: dorsum
- % coverage: 10
- Type of wrap if used: gauze

REMOVAL OF TEST SUBSTANCE
- Washing (if done): once usinsg cotton seed oil
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kb bw
- Concentration (if solution): n.a.
- Constant concentration used: yes
- For solids, paste formed: yes

Duration of exposure:

24 h

Doses:

2000 mg/kbg bw

No. of animals per sex per dose:

5

Control animals:

not required

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD0

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

none

Clinical signs:

other: none

Gross pathology:

No effects

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

The dermal LD50 was determined to be > 2000 mg / kg body weight.

Executive summary:

LD50: > 2000 mg /kg bw

Species/strain: WISTAR Crl: WI(Han) rats

Vehicle (moistening): cottonseed oil

Number of animals: 5 male and 5 female

Duration of exposure: 24 hours

Method: OECD 402; EC 440/2008, Method B.3; OPPTS 870.1200

Table 1: Results per Step

Sex	Dose (mg/kg bw)	Number of animals	Deaths
male	2000	5	0
female	2000	5	0

Signs of toxicity related to dose level used, time of onset and duration:

No treatment-related effects were observed

Effect on organs (related to dose level):

No treatment-related effects were observed.

Signs of irritation:

No erythema or oedema was observed, scratches were observed in 1 of 5 male animals.

Conclusion

Under the conditions of the present study, single dermal application of the test item to rats at a dose of 2000 mg/kg body weight was associated

with neither mortality nor signs of toxicity. In one male animal scratches were observed from day 6 until the end of the observation period.

The dermal LD50 was determined to be > 2000 mg/ kg body weight.