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Diss Factsheets

Administrative data

Description of key information

The substance is considered to be non hazardous to rats by assessment of experimental on other chlorinated copper phthalocyanines.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across source
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read-across source
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read-across source
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read-across source
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read-across source
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read-across source
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read-across source
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across source
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Species:
rat
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: no mortality
Interpretation of results:
GHS criteria not met
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
Value:
2 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

CAS No. 147-14-8:

Oral

There are valid data available for the assessment of the acute oral toxicity of Copper phthalocyanine. Five male and five female Sprague-Dawley rats were treated with 200, 1600, 3200, 6400 mg/kg bw under standardized conditions; the test method is comparable to OECD guideline 401. The animals were observed for 14 d, necropsy was performed even with the survivors. The LD50 was > 6400 mg/kg bw for male and female rats. No mortality was observed at any dose group and autopsy revealed no relevant findings. Clinical signs were reported for all groups. In the 6400 - 3200 mg/kg bw groups, ca. 4 hours after application the animals were found in a crouched down position with intermittent breath. On the following morning slight apathy, a crouched down position and intermittent breath were observed. The stool of the animals was bluish discoloured until day 4. On the following days the animals were without any findings. In the 1600 - 200 mg/kg bw groups, immediately after application, irregular breath and masticatory movement were observed, after 4 hours the animals were found in a crouched down position. On the following days until day 3, the stool of the animals was bluish discoloured but later on the animals were without any findings (BASF AG, 1971).

In another supporting study, conducted with five male and five female mice per group, the animals were treated with 0 or 16000 mg/kg bw under standardized conditions and were observed for 14 d, necropsy was performed with all animals. The LD50 was > 16000 mg/kg bw for male and female mice. No mortality was observed and autopsy revealed no relevant findings. The following clinical signs were reported shortly after dosing in all treated mice: pilo-erection and abnormal body carriage (hunched posture) and abnormal gait (waddling). These findings were accompanied by lethargy (4 animals), ptosis (1 animal), diarrhoea, coloured blue (1 animal). Recovery of all treated mice as judged by external appearance and behaviour, was apparently complete within 4 days of dosing (Huntingdon 1981, Val. 2).

Other studies with partially limited reliability provided a LD50 range of > 10000 to > 15000 mg/kg bw in rats (Kurlandsky 1984, Val. 4; Webb 1984 Val. 4), the LD 50 value for another common test species (mouse) was > 10000 mg/kg bw (Gosselin 1976, Val. 4).

Dermal

There are valid data available for the assessment of the acute dermal toxicity of Copper phthalocyanine. Five male Wistar rats were treated with 5000 mg/kg bw under standardized conditions; the test method was acc. to OECD guideline 402 (limit test). The animals were observed for 14 d, necropsy was performed even with the survivors. The LD50 was > 5000 mg/kg bw for male rats. No mortality was observed, autopsy revealed no relevant findings and no clinical signs of toxicity were reported. Body weight gain was within the normal range (Synthesia 2009, Val. 2).

CAS No. 1328-53-6:

Oral

There are valid data available for the assessment of the acute oral toxicity of polychloro copper phthalocyanine. Five male and five female Sprague-Dawley rats were treated with doses of 200, 1600, 3200 and 6400 mg/kg bw of polychloro copper phthalocyanine under standardized conditions; the test method is comparable to OECD guideline 401 (BASF AG, 1971). The animals were observed for 14 d, necropsy was performed even with the survivors. The LD50 was > 6400 mg/kg bw for male and female rats. All animals survived, no mortality was observed, and no abnormalities were found in the organs. Green feces were observed in all animals treated 24 hours after application of the test material. Dyspnea was observed in animals of the 1600 mg/kg bw group immediately after treatment, but was reversible.

In a supporting limit test,comparable to OECD guideline 401, five Sprague-Dawley rats per sex were administered to a single dose of 5000 mg/kg bw polychloro copper phthalocyanine (BASF AG 1980). The animals were observed for 14 d, necropsy was performed even with the survivors. Here, the LD50 was > 5000 mg/kg bw. All animals survived, no mortality was observed, and no abnormalities were found in the organs. Dyspnea, apathy, green feces as well as a poor general state were observed. A slight decrease of the average body weight in the female group was seen on day 13.

Another study in rat with partially limited reliability provided a LD50 range of > 2000 to > 10000 mg/kg bw polychloro copper phthalocyanine in rats, in all three cases no mortalities occured (MHLW 2000, Val.

The LD 50 value for another common test species (mouse) was > 10000 mg/kg bw polychloro copper phthalocyanine (Gosselin 1976, Val. 4).

Inhalation

No valid data are available for the assessment of the acute inhalation toxicity of polychloro copper phthalocyanine. A standardized inhalation hazard test was conducted to assessthe acute inhalation toxicityof polychloro copper phthalocyanine. However, the system used was unsuitable in this case (Val. 4), as the IHT is insufficient for non-volatile substances, such as the solid substance polychloro copper phthalocyanine. 0/6 rats died after 7 h exposure at room temperature. No clinical signs of toxicity were seen and autopsy revealed no abnormal findings. A considerable formation of dust was reported (BASF AG 1980).

 

CAS No. 574-93-6:

Oral

There are valid data available for the assessment of the acute oral toxicity of Heliogen Blue MFA. In a limit test (comparable to OECD guideline 401), five Sprague-Dawley rats per sex were administered 5000 mg/kg bw Heliogen Blue (BASF AG 1980). The animals were observed for 14 d, necropsy was performed even with the survivors. The LD50 was > 5000 mg/kg bw. All animals survived, no mortality was observed. No clinical signs of toxicity were seen. Autopsy revealed no abnormal findings.

In a supporting study using a test method also comparable to OECD guideline 401, five Sprague-Dawley rats per sex were administered 5000, 6400, 8000 and 10000 mg/kg bw Heliogen Blue MFA, respectively (BASF AG 1980). The animals were observed for 14 d, necropsy was performed even with the survivors. The LD50 was > 5000 mg/kg bw. All animals survived, no mortality was observed. No clinical signs of toxicity were seen. Autopsy revealed no abnormal findings.

CAS No. 14302 -13 -7:

Oral

There are valid data available for the assessment of the acute oral toxicity of Lionol Green 6YK. In a limit test five HC/CFLP mice of both sexes were administered to single doses of 0 or 5000 mg/kg bw Lionol Green 6YK (Huntingdon 1984, Val.2). The animals were observed for 14 d, necropsy was performed with all animals. The LD50 was > 16000 mg/kg bw. All animals survived, no mortality was observed, and no abnormalities were found in the organs. Pilo-erection was observed following dosing in all treated mice with recovery apparently completed by day 2.

CAS No. 27614-71-7:

Oral

There are valid data available for the assessment of the acute oral toxicity of Hostaperm Blau BT-729-D. In a limit test five Sprrague-Dawley rats of both sexes were administered to a single dose of 2000 mg/kg bw (acc. OECD 401, Aventis Pharma 2000). The animals were observed for 14 d, necropsy was performed with all animals. The LD50 was > 2000 mg/kg bw. All animals survived, no mortality was observed, and no abnormalities were found in the organs. Development of body weight was not impaired, except one female, which suffered a loss of body weight between day 8 and day 15. Bluish discoloured feces were observed after the administration of the test material. From day 4 until the end of the study no findings were observed.

Justification for classification or non-classification