Benzenamine, 4-[(4-aminophenyl)(4-imino-2,5-cyclohexadien-1-ylidene)methyl]-, N-Me derivatives, molybdatephosphates

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

8 Nov 1993 - 30 Nov 1993

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1993

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Benzenamine, 4-[(4-aminophenyl)(4-imino-2,5-cyclohexadien-1-ylidene)methyl]-, N-Me derivatives, molybdatephosphates

EC Number:

268-006-8

EC Name:

Benzenamine, 4-[(4-aminophenyl)(4-imino-2,5-cyclohexadien-1-ylidene)methyl]-, N-Me derivatives, molybdatephosphates

Cas Number:

67989-22-4

Molecular formula:

C24H27N3

IUPAC Name:

4-{[4-(dimethylamino)phenyl][4-(methylamino)phenyl]methyl}-N,N-dimethylcyclohexa-2,5-dien-1-iminium; 4-{bis[4-(dimethylamino)phenyl]methylidene}-N,N-dimethylcyclohexa-2,5-dien-1-iminium; 4-{bis[4-(methylamino)phenyl]methyl}-N,N-dimethylcyclohexa-2,5-dien-1-iminium

Test material form:

solid: nanoform, no surface treatment

Details on test material:

Product Number 0348N
Batch Number 15101887

Details on Nanoform
Shape
Shape Category: spheroidal
Shape: spherical
Pure Shape: Yes
Typical Composition: ≤100%
range: >0; ≤100%

Particle size distribution & range
Shape Category: spheroidal
Percentile D10, typical value: 30nm
Percentile D10, range: ≥10; ≤50nm
Percentile D50, typical value: 45nm
Percentile D50, range: ≥30; ≤100nm
Percentile D90, typical value: 60nm
Percentile D90, range: ≥45; ≤150nm
Fraction in size range 1-100nm:≥50; ≤100%

Crystallinity
structure: Amorphous
Pure structure: Yes

Specific Surface Area
Typical specific surface area: ca. 40m2/g
Range: ≥10; ≤200m2/g
Skeletal density: 1.8 g/cm3

Surface Functionalisation/treatment
surface treatment applied no

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No. of test material: 0348N Violet Lumiere R-NC-PM STD/ 901090
- Expiration date of the lot/batch: 7 Oct 1993
- Physical appearance: violet powder
- Storage: room temperature

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: 5 – 8 weeks old
- Weight at study initiation: males: 147 – 158 g; females: 143 – 162g
- Fasting period before study:
- Housing: solid floor polypropylene cages furnished with woodflakes
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 21
- Humidity (%): 41 – 59
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

arachis oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 200mg/mL

MAXIMUM DOSE VOLUME APPLIED: 2000 mg/kg bw

Doses:

Dose level: 2000 mg/kg
Concentration: 200 mL/kg
Dose volume: 10 mL/kg

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 0.5, 1, 2 and 4 hours; and then once daily for 14 days.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: no signs of systematic toxicity were noted during the study; all animals showed expected gain in bodyweight.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

None

Clinical signs:

other: none

Gross pathology:

No signs of systematic toxicity were noted during the study

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The acute oral median lethal dose (LD50) of the test item in the Sprague-Dawley strain rat was found to be greater than 2000 mg/kg bodyweight.