[2,9,16,23-tetrachloro-29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]copper

Repeated dose toxicity: oral

Administrative data

Endpoint:

short-term repeated dose toxicity: oral

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Guideline study (Japanese guideline). The original report was written in Japanese, an abstract and the relevant results (detailled) were available in English.

Data source

Reference

Reference 1

Reference Type:

publication

Title:

Unnamed

Year:

1995

Reference 2

Reference Type:

publication

Title:

Twenty-eight Day Repeat Dose Toxicity Test of Phthalocyanine Blue in Rats

Author:

Japan Existing Chemical Data Base (JECDB)

Year:

2009

Bibliographic source:

http://dra4.nihs.go.jp/mhlw_data/home/file/file147-14-8.html (original report is in Japanese; an abstact is available in English)

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)

GLP compliance:

not specified

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32 copper

EC Number:

205-685-1

EC Name:

29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32 copper

Cas Number:

147-14-8

IUPAC Name:

[29H,31H-phthalocyaninato(2-)-kappa~2~N~29~,N~31~]copper

Details on test material:

- Name of test material (as cited in study report): Phtalocyanine Blue, Pigment Blue-15
- Analytical purity: technical grade

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Analytical verification of doses or concentrations:

not specified

Duration of treatment / exposure:

28 days

Frequency of treatment:

daily

Doses / concentrations

Remarks:

Doses / Concentrations:
0, 40, 200 and 1000 mg/kg/day
Basis:
other: nominal in vehicle

No. of animals per sex per dose:

10 animals per sex per dose

Control animals:

yes, concurrent vehicle

Details on study design:

Administration period: 28 days for males and females
Post-exposure period: Terminal sacrifice was on day 29 or 43

Examinations

Observations and examinations performed and frequency:

CAGE SIDE OBSERVATIONS: Yes
DETAILED CLINICAL OBSERVATIONS: Yes
BODY WEIGHT: Yes
FOOD CONSUMPTION: Yes
HAEMATOLOGY: Yes
CLINICAL CHEMISTRY: Yes

Sacrifice and pathology:

GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes

Results and discussion

Results of examinations

Details on results:

GENERAL OBSERVATIONS:
No changes in general condition, body weight gain or food consumption were detected in any of the groups.

HAEMATOLOGY:
After the 28 days of administration, a slight, but significant decrease in red blood cell count (RBC) and decrease of hemoglobin (Hb) and packed cell volume (PCV) were detected in the 200 and 1000 mg/kg male groups. These slight changes were dose dependent. After the recovery period, a significant increase of erythroblasts was detected in the 1000 mg/kg female group.

ORGAN WEIGHT:
Increases of absolute organ weights of lung, spleen, adrenal and salivary gland and a tendency for increased relative organ weights of the spleen, evident in the 1000 mg/kg male group, were detected.

PATHOLOGY:
Increases of absolute organ weights of lung, spleen, adrenal and salivary gland and a tendency for increased relative organ weights of the spleen were evident in the 1000 mg/kg male group. No histopathological changes due to administration of phthalocyanine blue were detected.

Effect levels

1

Dose descriptor:

NOAEL

Effect level:

1 000 mg/kg bw/day (nominal)

Sex:

male/female

2

Dose descriptor:

NOEL

Effect level:

40 mg/kg bw/day (nominal)

Sex:

male/female

Target system / organ toxicity

Critical effects observed:

not specified