1-Octadecanaminium,N,N-Dimethyl-N-Octadecyl-,(Sp-4-2)-[29h,31h-Phthalocyanine2-Sulfonato(3-)-N 29,N 30,N 31,N 32]Cuprate(1-)

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1989

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Comparable to guideline study; well documented study report.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1989

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

other: Annex V

Deviations:

yes

Remarks:

In the report the first day of the treatment is noted as day 1 instead of day 0 due to changed procedures; all animals were provided with tap-water and not with tap-water diluted with decalcified water as per protocol

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Deviations:

yes

Remarks:

In the report the first day of the treatment is noted as day 1 instead of day 0 due to changed procedures; all animals were provided with tap-water and not with tap-water diluted with decalcified water as per protocol

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Details on test material:

- Molecular formula (if other than submission substance): NDA
- Molecular weight (if other than submission substance): NDA
- Smiles notation (if other than submission substance): NDA
- Substance type: NDA
- Physical state: Blue powder
- Analytical purity: NDA
- Impurities (identity and concentrations): NDA
- Composition of test material, percentage of components: NDA
- Isomers composition: NDA
- Purity: 100% - moisture
- Lot/batch No.: Ref Mix 51785
- Expiration date of the lot/batch: NDA
- Stability under test conditions: Stable under storage conditions
- Storage condition of test material: At room temperature in the dark
- Other: Disposal category III

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
-Source: Charles River Wiga. Sulzfeld, West-Germany
-Age at study initiation: approx. 7 weeks
-Weight at study initiation: males: 230~249 g; females: 158~171 g.
-Fasting period before study: Feed was withheld overnight prior to dosing until approximately 3-4 h after administration of the test article.
-Housing: housed in groups of 5 per sex in polycarbonate cages containing purified sawdust as bedding material.
-Diet: free access to standard pelleted laboratory animal diet (RMH-B from Hope Farms, The Netherlannds)
-Water: free access to tap-water.
-Acclimation period: at least 5 days under laboratory conditions.

ENVIRONMENTAL CONDITIONS
-Temperature (°C): 21± 3 oC
-Humidity (%): 30-70%
-Air changes: 7.5 – 15 air changes per hr
-Photoperiod (12 hrs dark /12 hrs light)

IN-LIFE DATES: From: Jan 5th 1989 To: Jan 19th 1989

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 500 mg/ml
- Amount of vehicle (if gavage): 10 ml/kg bw
- Justification for choice of vehicle: NA
- Lot/batch no. (if required): NA
- Purity: NA

MAXIMUM DOSE VOLUME APPLIED:
DOSAGE PREPARATION (if unusual): NA
CLASS METHOD (if applicable) NA
- Rationale for the selection of the starting dose: NDA

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

5/ses/dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: on the day of dosing (Day1) and twice daily for at least 14 days.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Statistics:

Using the mortality data obtained, an estimate of the acute oral median lethal dose (LD50) of the test material was made.

Results and discussion

Preliminary study:

Not applicable

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Mortality:

Male: 5000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 5000 mg/kg bw; Number of animals: 5; Number of deaths: 0

Clinical signs:

other: No deaths occurred and no clinical signs of toxicity or behavioral changes were observed

Gross pathology:

No treatment-related macroscopic findings were observed via microscopic examination for all animals at termination.

Other findings:

- Organ weights: NDA
- Histopathology: NDA
- Potential target organs: NDA
- Other observations: NDA

Any other information on results incl. tables

The information contained in this robust summary may not be published, broadcast, rewritten or otherwise distributed without the prior written authority of the owner of the study.

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: other: EEC Directive 83/467/EEC, Annex VI of the EEC Directive 67/548/EEC

Conclusions:

The acute oral median lethal dose (LD50) of the test material in the Wistar strain, outbred Albino rats was found to be greater than 5000 mg/kg bodyweight. The test substance was classified as non-toxic.

Executive summary:

In an acute oral toxicity study, 2 groups fasted 7 week old Wistar strain,outbred Albino rats(five male and five female) were given a single oral dose of the test material in water a dose level of   5000  mg/kg bw and observed for14 days. No mortality occurred. No signs of systemic toxicity, or behavioral changes were noted during the study, and no abnormalities were noted at necropsy.All animals showed expected bodyweight gain during the study. The oral LD50 value of the test material in rats of both sexes was stimulated to exceed 5000 mg/kg bw.