Polychloro copper phthalocyanine

Endpoint summary

Key value for chemical safety assessment

Effects on fertility

Description of key information

CAS No. 147-14-8:
Fertility / Developmental Toxicity:
Screening test, rat, oral by gavage: NOAEL P/F1 = 1000 mg/kg bw/day (acc. OECD guideline 421, GLP, JETOC 1995)

 

90 day subchronic study: no histopathological changes on reproductive organs (Batelle 76-34-106002, Val. 2)
28 day subacute study: no histopathological changes on reproductive organs (JETOC 2001, Val. 1)

Effect on fertility: via oral route

Endpoint conclusion:

no adverse effect observed

Effect on fertility: via inhalation route

Endpoint conclusion:

no study available

Effect on fertility: 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 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.

Effects on developmental toxicity

Description of key information

Fertility / Developmental Toxicity:
Screening test, rat, oral by gavage: NOAEL P/F1 = 1000 mg/kg bw/day (acc. OECD guideline 421, GLP, JETOC 1995)

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

Data derived from the histopathological part of subchronic and subacute studies with polychloro copper phthalocyanine as well as from a preliminary reproduction toxicity screening test with copper phthalocyanine suggest - together with the knowledge of the low bioavailability of the substances in question - that phthalocyanins are not considered to be able to induce effects on fertility and development.

Therefore, there is no need for classification according to reproductive/developmental toxicity.