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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Key value for chemical safety assessment

Effects on fertility

Link to relevant study records

Referenceopen allclose all

Endpoint:
two-generation reproductive toxicity
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study does not need to be conducted because (i) the substance is of low toxicological activity (no evidence of toxicity seen in any of the tests available), (ii) it can be proven from toxicokinetic data that no systemic absorption occurs via relevant routes of exposure (e.g. plasma/blood concentrations below detection limit using a sensitive method and absence of the substance and of metabolites of the substance in urine, bile or exhaled air) and (iii) there is no or no significant human exposure
Qualifier:
according to guideline
Guideline:
OECD Guideline 416 (Two-Generation Reproduction Toxicity Study)
Reproductive effects observed:
not specified
Endpoint:
screening for reproductive / developmental toxicity
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
Dose descriptor:
NOAEL
Effect level:
1 000 mg/kg bw/day
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: no adverse findings
Critical effects observed:
no
Dose descriptor:
NOAEL
Generation:
F1
Effect level:
1 000 mg/kg bw/day
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: no adverse findings
Critical effects observed:
no
Reproductive effects observed:
no
Effect on fertility: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
1 000
Study duration:
subacute
Species:
rat
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available
Additional information

A read-across is performed, which is based on the hypothesis that the copper phthalocyanine pigments are too insoluble in water or fat / octanol for systemic uptake. A data matrix and further information are provided in the chapter on toxicokinetic properties. The pigment is considered to show no adverse effects at the limit dose for the oral and dermal route. It is considered to behave like an inert dust upon inhalation.

Available data supporting this read-across are summarized below:

CAS No. 147-14-8: A GLP conform reproduction/developmental toxicity screening study was conducted by gavage with the test material according to OECD guideline 421 (JETOC 1995). Groups of 12 Sprague-Dawley per sex per dose were daily exposed by gavage to 0, 40, 200, 1000 mg/kg bw/day of the test substance. The administration period for males was from 14 days before mating, during the mating period and copulation, until 46 days. The administration period for females was from 14 days before mating to day 3 of lactation. Males were killed on days 28 and 47, females on day 28 and on day 4 of lactation. Maternal examinations included cage side observations (at least once every day visual inspection, observation of appearance and palpation), detailled clinical observations (reproductive capacity, examination of the oestrous cycle, the recording of occurrence of copulation and gestation, fertility, implantation, delivery and nursing indices, maternal behaviour, birth rate, pregnancy period), examination of body weight and of feed intake. Post-mortem examinations were conducted: Organs were removed, reproductive organs were weighed. Ovaries, uterus, harderian gland, eyeball, mammary gland, and spleen were histopathologically examined. The ovaries and uterine content were examined after termination. The examinations included gravid uterus weight, number of corpora lutea and the number of implantations. Fetal examinations were also conducted, details are listed below.A blue coloration of faeces was noted in all animals of the groups receiving 40 mg/kg bw or more; moreover blue-green or grayish blue discolorations of the contents of the stomach and intestines were noted in a few animals of the 200 mg/kg group and in almost all animals of both sexes in the 1000 mg/kg group. These changes were due to the colour of the test substance. No changes were observed in terms of mortality, body weight, food consumption, organ weight and histopathological examination. No effects were noted on the following endpoints: Reproductive ability of either sex (assessment of this endpoint included the examination of the oestrous cycle, the recording of occurrence of copulation and gestation, the calculation of copulation, fertility, implantation, delivery and nursing indices, the weight of testes and epididymis as well as histopathological examination of the reproductive organs), delivery, maternal behavior, viability, clinical signs and body weight changes. No statistically significant differences were observed in rate of live/dead pups born.

CAS No. 1328 -53 -6: Additionally, repeated dose toxicity studies with polychloro copper phthalocyanine and copper phthalocyanine (for study details see chapter 7.5) reported no changes in rats' testes (90-day and 28-day study) and ovaries (28-day study) as confirmed by histopathological investigations.

Short description of key information:
The copper phthalocyanine pigments are considered to be too insoluble and bulky for systemic uptake. A screening study (OECD 421) with the smallest copper phthalocyanine showed no effects at the limit dose. Also, no effects on reproductive organs were noted upon subchronic feeding of mice and rats. Overall, the substance is considered to be non toxic to reproduction.

Effects on developmental toxicity

Link to relevant study records

Referenceopen allclose all

Endpoint:
developmental toxicity
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study does not need to be conducted because the substance is of low toxicological activity (no evidence of toxicity seen in any of the tests available), it can be proven from toxicokinetic data that no systemic absorption occurs via relevant routes of exposure (e.g. plasma/blood concentrations below detection limit using a sensitive method and absence of the substance and of metabolites of the substance in urine, bile or exhaled air) and there is no or no significant human exposure
Qualifier:
according to guideline
Guideline:
OECD Guideline 414 (Prenatal Developmental Toxicity Study)
Species:
rabbit
Abnormalities:
not specified
Developmental effects observed:
not specified
Endpoint:
developmental toxicity
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study does not need to be conducted because the substance is of low toxicological activity (no evidence of toxicity seen in any of the tests available), it can be proven from toxicokinetic data that no systemic absorption occurs via relevant routes of exposure (e.g. plasma/blood concentrations below detection limit using a sensitive method and absence of the substance and of metabolites of the substance in urine, bile or exhaled air) and there is no or no significant human exposure
Qualifier:
according to guideline
Guideline:
OECD Guideline 414 (Prenatal Developmental Toxicity Study)
Species:
rat
Abnormalities:
not specified
Developmental effects observed:
not specified
Effect on developmental toxicity: via oral route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via inhalation route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via dermal route
Endpoint conclusion:
no study available
Additional information

CAS No. 147-14-8:

A GLP conform reproduction/developmental toxicity screening study was conducted by gavage with the test material according to OECD guideline 421 (JETOC 1995). Groups of 12 Sprague-Dawley per sex per dose were daily exposed by gavage to 0 40, 200, 1000 mg/kg bw/day of the test substance. The administration period for males was from 14 days before mating, during the mating period and copulation, until 46 days. The administration period for females was from 14 days before mating to day 3 of lactation. Males were killed on days 28 and 47, females on day 28 and on day 4 of lactation. Maternal examinations were conducted, details are listed above. Fetal examinations included general observations about the state (clinical signs, body weight change) and neonatal survival status. Post-mortem, the whole body was fixed in formalin solution.

No statistically significant differences were observed in rate of live/dead pups born. No evidence was found suggesting a relation with the administration of the tested substance and clinical signs, body weight change or autopsy findings for both male and female pups.

Justification for classification or non-classification

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

The available screening study is reliable and suitable for classification purposes under Regulation 1272/2008. As a result, the substance is not considered to be classified for fertility or developmental toxicity under Regulation (EC) No. 1272/2008, as amended for the tenth time in Regulation (EU) No 2017/776.

During the four days covered in the screening study, no effects via lactation were observed.

Additional information