1,2-Naphtoquinonediazide-5-sulfonylchloride (or sulfonic acid) esters with 4,6-bis(1-(4-hydroxyphenyl)-1-methylethyl)-1,3-dihydroxybenzene

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Start: 1999-12-07 End: 1999-12-23

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1999

Report date:

2000

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Version / remarks:

1996

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

GLP compliance:

yes

Test type:

acute toxic class method

Test material

Test material information

Constituent 1

Reference substance name:

4-(2-{2,4-dihydroxy-5-[2-(4-hydroxyphenyl)propan-2-yl]phenyl}propan-2-yl)phenyl 6-(-lambda5-diazynylidene)-5-oxo-5,6-dihydronaphthalene-1-sulfonate

Molecular formula:

C34H30N2O7S

IUPAC Name:

4-(2-{2,4-dihydroxy-5-[2-(4-hydroxyphenyl)propan-2-yl]phenyl}propan-2-yl)phenyl 6-(-lambda5-diazynylidene)-5-oxo-5,6-dihydronaphthalene-1-sulfonate

Constituent 2

Reference substance name:

4-[2-(2,4-dihydroxy-5-{2-[4-({[6-(-lambda5-diazynylidene)-5-oxo-5,6-dihydronaphthalen-1-yl]sulfonyl}oxy)phenyl]propan-2-yl}phenyl)propan-2-yl]phenyl 6-(-lambda5-diazynylidene)-5-oxo-5,6-dihydronaphthalene-1-sulfonate

Molecular formula:

C44H34N4O10S2

IUPAC Name:

4-[2-(2,4-dihydroxy-5-{2-[4-({[6-(-lambda5-diazynylidene)-5-oxo-5,6-dihydronaphthalen-1-yl]sulfonyl}oxy)phenyl]propan-2-yl}phenyl)propan-2-yl]phenyl 6-(-lambda5-diazynylidene)-5-oxo-5,6-dihydronaphthalene-1-sulfonate

Test material form:

solid

Details on test material:

Batch PW-9F-29

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, Germany
- Females nulliparous and non-pregnant: yes
- Age at study initiation: young adults, approx. 6 weeks old
- Weight at study initiation: body weight variation did not exceed +/- 20 % of the sex mean
- Fasting period before study: food was withheld overnight (for a maximum of 20 hours) prior to dosing until approximately 3-4 hours after administration of the test substance.
- Housing: group housing of 3 animals per sex per cage in labelled polycarbonate cages containing purified sawdust as bedding material (SAWl, Jelu Werk, Rosenberg, Germany).
- Diet: ad libitum, standard pelleted laboratory animal diet (from Carfil Quality BVBA, Oud-Turnhout, Belgium)
- Water: ad libitum, tap water
- Acclimation period: at least 5 days before start of treatment under laboratory conditions

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21
- Humidity (%): 30-70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

polyethylene glycol

Details on oral exposure:

VEHICLE:
- Concentration in vehicle: 200 mg/ml
- Amount of vehicle (if gavage): 10 ml/kg body weight
- Justification for choice of vehicle: based on a pretest perÍormed at NOTOX

MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg body weight (2000 mg/kg body weight)

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: the first group was treated at a dose level of 2000 mg/kg body weight. The absence or presence of mortality of animals dosed at one step determined the next step, based on the test procedure defined in the guidelines.

Doses:

2000 mg/kg body weight

No. of animals per sex per dose:

3 animals per sex and per dose.

Control animals:

no

Details on study design:

- Duration of observation period following administration: 15 days
- Frequency of observations and weighing:
- mortality/viability= twice daily
- body weight: day 1 (pre-adminstration, 8 and 15
- 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.