Registration Dossier
Registration Dossier
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EC number: 238-238-4 | CAS number: 14302-13-7
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
- Report date:
- 1984
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- ; the study was conducted with mice (rat is the standard species, recommended in OECD guideline 401).
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- [1,3,8,16,18,24-hexabromo-2,4,9,10,11,15,17,22,23,25-decachloro-29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]copper
- EC Number:
- 238-238-4
- EC Name:
- [1,3,8,16,18,24-hexabromo-2,4,9,10,11,15,17,22,23,25-decachloro-29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]copper
- Cas Number:
- 14302-13-7
- Molecular formula:
- C32Br6Cl10CuN8
- IUPAC Name:
- [1,3,8,16,18,24-hexabromo-2,4,9,10,11,15,17,22,23,25-decachloro-29H,31H-phthalocyaninato(2-)-kappa~2~N~29~,N~31~]copper
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Name of test material (as cited in study report): Lionol Green 6YK
- Analytical purity: no data given
- Substance type: fine green powder
- Storage condition of test material: at ambient temperature
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): Lionol Green 6YK
- Analytical purity: no data given
- Substance type: fine green powder
- Storage condition of test material: at ambient temperature
Test animals
- Species:
- mouse
- Strain:
- other: HC/CFLP (ICI strain 1)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hacking and Churchill Ltd., Huntingdon, Cambridgeshire, UK
- Age at study initiation: 4 - 6 weeks
- Weight at study initiation: 18 - 23 g
- Fasting period before study: overnight prior to and approx. 4 h after dosing
- Housing: allocation to cages within the treatment group; housing in plastic cages with sawdust bedding
- Diet: standard laboratory rodent diet (Scientific Feeds LAD 1 obtained from Special Diet Services Ltd., Witham, Essex, UK), ad libitum
- Water: ad libitum
- Acclimation period: minimum 6 days
ENVIRONMENTAL CONDITIONS
- Temperature: 20 - 23 °C
- Humidity: 64 %
- Air changes: 15 per hr
- Photoperiod: 12 hrs dark / 12 hrs light
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- Concentration of the test material in vehicle:
- 40 % w/v suspension
- Amount of test material applied per gavage:
- 40 ml/kg bw for 16000 mg/kg bw
The control animals were treated with vehicle alone. - Doses:
- 0 and 16000 mg/kg bw
- No. of animals per sex per dose:
- 5 animals per sex per dose.
- Control animals:
- yes
- Details on study design:
- Animals were observed soon after dosing; then at frequent intervals for the remainder of day 1, On subsequent days the animals were observed at least twice. Clinical signs were recorded at each observation.
All animals were observed for 14 days after dosing and the nature, severitx, approx. time of onset and duration of each toxic sign were recorded.
Individual body weights were recorded on day of dosing (day 1) and on days 8 and 15.
All animals were killed on day 15 and were subjected to a macroscopic post mortem examination.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 16 000 mg/kg bw
- Mortality:
- There were no mortalities.
- Clinical signs:
- other: Pilo-erection was observed following dosing in all treated mice with recovery apparently completed by day 2.
- Gross pathology:
- Terminal autopsy revealed no findings.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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