Copper, [29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]-, [[2-[(4-chloro-6-methoxy-1,3,5-triazin-2-yl)amino]ethyl]amino]sulfonyl sulfo derivs., sodium salts

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1975

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:

1975

Report date:

1975

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Copper, [29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]-, [[2-[(4-chloro-6-methoxy-1,3,5-triazin-2-yl)amino]ethyl]amino]sulfonyl sulfo derivs., sodium salts

EC Number:

275-060-6

EC Name:

Copper, [29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]-, [[2-[(4-chloro-6-methoxy-1,3,5-triazin-2-yl)amino]ethyl]amino]sulfonyl sulfo derivs., sodium salts

Cas Number:

70955-64-5

Molecular formula:

C36.2H18.9Cl0.7CuN11.5O10.2S3.4Na2.7

IUPAC Name:

Copper, [29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]-, [[2-[(4-chloro-6-methoxy-1,3,5-triazin-2-yl)amino]ethyl]amino]sulfonyl sulfo derivs., sodium salts

Test material form:

solid: particulate/powder

Details on test material:

Reactive Blue 71

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source:
- Females (if applicable) nulliparous and non-pregnant: [yes]
- Age at study initiation:
- Weight at study initiation:
- Fasting period before study: 16 hours
- Housing: group
- Diet (ad libitum):
- Water (ad libitum): tap water
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C):
- Humidity (%):
- Air changes (per hr): ca. 15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: To:

Administration / exposure

Route of administration:

oral: gavage

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

5 females
5 males

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observation: clinical signs multiple times on day one, thereafter twice daily; body weight: weekly
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Remarks on result:

not determinable due to absence of adverse toxic effects

Mortality:

No animals died at 5000 mg/kg

Clinical signs:

No significant signs of systemic toxicity observed.

Body weight:

no effects

Gross pathology:

no test substance related findings

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The acute oral lethal dose was tested to be >5000 mg/kg bw in both male and female rats.

Executive summary:

The test substance was tested for acute oral toxicity in 5 female and 5 female rats per dose group. The test substance was administered as a single dose of 5000 mg/kg bw by gavage after a 16-hour fasting period. The animals were observed for 14 days for signs of toxicity and body weight development.

Surviving rats at the end of the observation period underwent necropsy and macroscopical evaluation.The LD50 was determined to be > 5000 mg/kg bw.