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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1979-02-01 to 1979 02-15
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report date:
1979

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Principles of method if other than guideline:
Internal Guideline Hoechst AG
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Nickel, [29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]-, chlorosulfonyl derivs., reaction products with 2-[(4-aminophenyl)sulfonyl]ethyl hydrogen sulfate monosodium salt, sodium salts
EC Number:
305-644-9
EC Name:
Nickel, [29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]-, chlorosulfonyl derivs., reaction products with 2-[(4-aminophenyl)sulfonyl]ethyl hydrogen sulfate monosodium salt, sodium salts
Cas Number:
94891-43-7
Molecular formula:
C32 H16 N8 Ni . C8 H11 N O6 S2 . 2 Na
IUPAC Name:
Nickel, [29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]-, chlorosulfonyl derivs., reaction products with 2-[(4-aminophenyl)sulfonyl]ethyl hydrogen sulfate monosodium salt, sodium salts
Test material form:
liquid

Test animals

Species:
rat
Strain:
Wistar
Remarks:
Hoe WISKf(SPF71)
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: inhouse
- Weight at study initiation: 222 to 240 g (average 233 g, s = +- 6.48g, n=10)
- Fasting period before study: 16 hours prior administration and 2 hours after administration
- Housing: plastic cage; wood shavings; in groups
- Diet: Altromin 1324 rat standard diet ad libitum
- Water: tap ad libitum

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: demineralized water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 25 % test item in a water solution (25g/ad 100 mL)
Doses:
5000 mg/kg body weight
(Application volumen 4.4 to 4.8 mL)
No. of animals per sex per dose:
10 females
Control animals:
no
Details on study design:
Observation period: 14 days after test substance administration
- Frequency of observations and weighing: weakly weighing
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Statistics:
Exact determination of LD50 not possible (Limit test)

Results and discussion

Effect levels
Key result
Sex:
female
Dose descriptor:
approximate LD50
Effect level:
ca. 5 000 mg/kg bw
Based on:
test mat.
Mortality:
4 animals died between 330 minutes and 24 hours after application
Clinical signs:
symptoms of the 4 died animals:
crouched position, raised hair, straitened lid slit, passivity, abdominal position, vestibular disorder, straddled legs, convulsions, tonic-clonic seizures, blood colored tear fluid, intermittent shallow breathing
surviving animals:
same clinical signs, but in milder form and reversible after 48 after administration
Body weight:
normal body weight gain during the observation period
Gross pathology:
Stomachs, small intestines, and fat tissue of the abdomen was blue colored (330 minutes p.a.).
Small intestines were green colored, black-blue colored pulpy stomach contents, and green colored fat tissue of the abdomen (1st / 2nd d).
Surviving animals: Macroscopically; greenish intestinal tract and an intensive dark green colored kidney.
A clearly green coloration of the cortex of the kidney was observed when the kidney was excised.
Other findings:
Urinary clear and colourless

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
LD50 of approximate 5000 mg/kg bw was determined. The substance is not classifiable according to CLP criteria.