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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Acute Toxicity: other routes

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Administrative data

Endpoint:
acute toxicity: other routes
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report date:
1980

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
Groups of mice were treated intraperitoneally. Mortality and physical condition were observed for 14 days following treatment.
GLP compliance:
no
Limit test:
no

Test material

Constituent 1
Reference substance name:
Aluminum, hydroxy[29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]-, chloro sulfo derivs., sodium salts
EC Number:
307-259-1
EC Name:
Aluminum, hydroxy[29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]-, chloro sulfo derivs., sodium salts
Cas Number:
97592-62-6
Molecular formula:
not available
IUPAC Name:
Aluminum, hydroxy[29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]-, chloro sulfo derivs., sodium salts
Test material form:
solid
Specific details on test material used for the study:
- Name as used in the study report: FAT 60'149/B
- Batch No.: Partie 1

Test animals

Species:
mouse
Strain:
other: Tif: MAG (SPF)
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: raised on the premises
- Weight at study initiation: group averages 22-31 g
- Age at study initiation: 8 to 9 weeks
- Housing: In groups of 5 in Macrolon cages (type 2)
- Diet: ad libitum mouse food - NAFAG, Gossau SG
- Water: ad libitum
- Acclimation period: at least 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 55 ± 10
- Photoperiod (hrs dark / hrs light): 14 / 10

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
other: distilled water containing 2 % carboxymethylcellulose + 0.1 % Tween 80
Details on exposure:
Animals were treated intraperitoneally with a suspension of the substance in 10 mL/kg bw.
Doses:
30, 100, 300, 1000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
Animals were treated intraperitoneally. Physical condition and rate of deaths were monitored throughout the whole observation period.
Statistics:
LD50 including 95 % confidence limits are calculated by the logit model .

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
540 mg/kg bw
Based on:
test mat.
95% CL:
>= 295 - <= 1 528
Mortality:
4/5 male animals in the 1000 mg/kg dose group died on day 3 after treatment. 2/5 female animals in the 300 mg/kg dose group died on day 4 after treatment, 1/5 female animals in the 1000 mg/kg dose group died on day 2 after treatment and 3/5 on day 3 after treatment.
Clinical signs:
Clinical signs that were observed are severe sedation (day one of the treatment), slight to moderate dyspnoae, moderate ruffled fur, ventral, lateral and curved body position. No symptoms were observed in the surviving animals after day 7.
Body weight:
- 30 mg/kg bw: pre-test male/female 22/22 g, at day 7 male/female 29/27 g, at day 14 male/female 31/27 g.
- 100 mg/kg bw: pre-test male/female 30/26 g, at day 7 male/female 29/27 g, at day 14 male/female 33/28 g.
- 300 mg/kg bw: pre-test male/female 31/25 g, at day 7 male/female 31/26 g, at day 14 male/female 34/28 g.
- 1000 mg/kg bw: pre-test male/female 30/26 g, at day 7 male/female 29/24 g, at day 14 male/female 33/27 g.
Gross pathology:
No substance related gross organ changes were seen.

Applicant's summary and conclusion