Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions (incomplete documentation, occlusive treatment)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1976
Report date:
1976

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
(occlusive treatment)
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
[N,N,N',N',N'',N''-hexaethyl-29H,31H-phthalocyaninetrimethylaminato(2-)-N29,N30,N31,N32]copper
EC Number:
249-125-4
EC Name:
[N,N,N',N',N'',N''-hexaethyl-29H,31H-phthalocyaninetrimethylaminato(2-)-N29,N30,N31,N32]copper
Cas Number:
28654-73-1
Molecular formula:
C47 H49 Cu N11
IUPAC Name:
[N,N,N',N',N'',N''-hexaethyl-29H,31H-phthalocyaninetrimethylaminato(2-)-N29,N30,N31,N32]copper
Details on test material:
- Physical state: solid
- Analytical purity: ca. 93%

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Wiga
- Weight range at study initiation: 135 - 161 g (males); 116 - 119 g (females)

ENVIRONMENTAL CONDITIONS: not reported

Administration / exposure

Type of coverage:
occlusive
Vehicle:
water
Details on dermal exposure:
TEST SITE
- Area of exposure: 50 cm²
- % coverage: > 10 %
- Site of exposure: right back

REMOVAL OF TEST SUBSTANCE
- Washing: with water containing mild detergent


TEST MATERIAL
- Amount applied: 2500 mg/kg bw (5 mL/kg bw)
- Concentration (if solution): 50 % (in water)
- For solids, paste formed: yes

Duration of exposure:
24 h
Doses:
2500 mg/kg bw
No. of animals per sex per dose:
5 rats
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of weighing: before application
- Frequency of observations: daily (on working day) day 1, 2, 5, 6, 7, 8, 9, 12, 13 and 14
- Necropsy of survivors performed: yes
Statistics:
not performed

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 500 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No mortality and no clinical signs were observed.
Mortality:
No mortality was observed.
Clinical signs:
No local or systemic signs of toxicity were observed. Only substance residues (light-blue) on the skin were seen during the whole observation period.
Body weight:
Changes in body weight are not documented.
Mean weights at initiation: 151 g (males); 117 g (females)
Gross pathology:
No abnormalities were observed.

Applicant's summary and conclusion