(E)-3-(benzyl(4-((4-nitrophenyl)diazenyl)phenyl)amino)propanenitrile

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

13 August 1998 to 27 August 1998

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1998

Report date:

1998

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

429-530-4

EC Name:

-

Cas Number:

96662-24-7

Molecular formula:

Hill formula: C22H19N5O2 CAS formula: C22H19N5O2

IUPAC Name:

3-[benzyl({4-[2-(4-nitrophenyl)diazen-1-yl]phenyl})amino]propanenitrile

Test material form:

solid: particulate/powder

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: HARLAN WINKLEMANN, Gartenstr. 27, 33178 Borchen, SPF breeding colony
- Age at study initiation: 6 - 10 weeks
- Weight at study initiation: Males - 271g, Females - 215g
- Housing: Fully air-conditioned rooms in macrolon cages (type 3) on soft wood granulate, one animal per cage
- Diet (e.g. ad libitum): ssniff R/M-H (V 1534), ad libitum
- Water (e.g. ad libitum): tap water in plastic bottles, ad libitum
- Acclimation period: seven days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22
- Humidity (%): 50
- Photoperiod (hrs dark / hrs light): 12 hours dark/12 hours light

Administration / exposure

Type of coverage:

occlusive

Vehicle:

other: Sesame Oil (Oleum sesami DAB 10)

Details on dermal exposure:

TEST SITE
- Area of exposure: Approximately 30 cm2
- Type of wrap if used: Foil

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Warm water
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg body weight
- For solids, paste formed: yes

VEHICLE
- Amount(s) applied (volume or weight with unit): 1.0ml per -0.5g

Duration of exposure:

24 h

Doses:

2000 mg/kg body weight

No. of animals per sex per dose:

Males - 5
Females - 5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations twice daily (morning and afternoon), on weekends and bank holidays only once. Animals weighed weekly.
- Necropsy of survivors performed: yes

Statistics:

Not reported.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

Male: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0 Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0

Clinical signs:

other: No clinical signs of toxicity related to dose levels was observed during the study.

Gross pathology:

Effects on organs: No macroscopic visable changes were observed.

Other findings:

The skin surface of the animals was large discoloured orange up to day six of the study

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the results obtained in the study the median lethal dose value (LD50) of the substance for the male and female rat is greater than 2000 mg/kg body weight.

Executive summary:

Study data conducted to EEC-Guideline B.3 of the Directive 92/68/EEC and OECD Guidleines for Testing of Chemicals 402 in compliance with GLP.

The median lethal dose value (LD50) of the substance for the male & female rat is greater than 2000 mg/kg body weight.