Copper chlorophthalocyanine

Endpoint summary

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

Reference 1

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Specific details on test material used for the study:

- Name of test material (as cited in study report): Pigment Green No.7
- Other Identifier in report: CAS 1328-53-6, chemical structure with completely chlorinated copper pthalocyanine

Species:

rat

Strain:

Crj: CD(SD)

Sex:

male/female

Details on test animals or test system and environmental conditions:

weight at study initation: 162 - 176g and 112 - 130g (male/female)
Temperature 23 +/- 3 °C
humidity 55 +/-20%
light/dark cycle 12h each

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

VEHICLE
- Amount of vehicle (if gavage): 0.5 ml / 100g body weight
- Justification for choice of vehicle: Pigment Green 7 is insoluble in water and suspendible in olive oil

CLASS METHOD:
- Rationale for the selection of the starting dose: Limit dose as the pigment was expected to be non toxic

Doses:

2000 mg /kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations daily, weighing weekly
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Remarks on result:

other: No mortality was observed.

Mortality:

No deaths occured in either sex during the observation period.

Clinical signs:

other: Abnormalities of general condition were not observed in any males or females during the observation period.

Gross pathology:

No abnormal findings were recorded.

Interpretation of results:

GHS criteria not met

Reference 2

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Specific details on test material used for the study:

- Synonyms: Copper tri/tetrachlorophthalocyanine pigment
- Substance type: blue powder
- Analytical purity: >85%
- Lot/batch No.: M200058
- Stability under test conditions: guaranteed for 4 hours
- Storage condition of test material: darkness at approx. 20 °C in a fume cupboard
- Other: different CAS No. are existing: 29719-96-8, 68987-63-3, 16040-69-0, 27614-71-7

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Winkelmann, Borchen, Germany
- Age at study initiation: 6-10 weeks
- Average weight at study initiation: males 189 g; females 178 g
- Fasting period before study: from ca. 16 h before to 3 - 4 h after treatment
- Housing: in fully air-conditioned rooms in macrolon cages (type 4) on soft wood granulate in groups of 5 animals
- Diet: ssniff (R) R/M-H (V 1534), ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 7 days

ENVIRONMENTAL CONDITIONS
- Temperature: 22 +- 3 °C
- Humidity: 50 +- 20 %
- Photoperiod: 12 hrs dark / 12 hrs light

Route of administration:

oral: gavage

Vehicle:

other: sesame oil

Details on oral exposure:

The animals received the compound as a 20 % suspension in sesame oil, the administration volume being 10 ml/kg bw.

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5 animals per sex per dose

Control animals:

no

Details on study design:

The prepared test substance was administered by gavage to fasted animals at the stated dosage. The observation period following treatment lasted for 14 days. Symptoms were recorded twice every day (in the morning and in the afternoon), on weekends and public holidays only once. During this time the animals were weighed weekly. At the end of the observation period, the animals were killed by CO2 asphyxilation, dissected and examined for macroscopically visible changes.

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Remarks on result:

other: no mortality occurred

Mortality:

No deaths occured during the whole study.

Clinical signs:

other: 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.

Gross pathology:

No macroscopically visible changes were seen.

Table 1: Individual body weights of rats

		bodyweight (g) at day
animal no.	sex	1	8	15
1	f	176	196	220
2	f	176	199	207
3	f	178	207	216
4	f	180	200	207
5	f	178	216	203
1	m	187	263	294
2	m	189	261	298
3	m	191	259	295
4	m	182	228	268
5	m	197	258	286

Interpretation of results:

GHS criteria not met

Conclusions:

Under the conditions of the limit test (accrding to OECD guideline 401) for acute toxicity after oral application, the LD50 for the test material is > 2000 mg/kg body weight for male and female rats.

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

Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. No mortality occurred at the limit dose of 2000 mg/kg bw. As a result, the substance is not considered to be classified for acute oral toxicity under Regulation (EC) No. 1272/2008, as amended for the thirteenth time in Regulation (EC) No. 2018/1480.