Calcium bis[3-nitro-4-[[2-oxo-1-[(phenylamino)carbonyl]propyl]azo]benzenesulphonate]

Endpoint summary

Key value for chemical safety assessment

Effects on fertility

Description of key information

Reproductive/Developmental Toxicity Screening Study: Read-across, NOAEL (fertility/develompent) >= 1 100 mg/kg bw/day, according to OECD 422, GLP-compliant, rat, 2012, K1

Link to relevant study records

Reference

Endpoint:

screening for reproductive / developmental toxicity

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Justification for type of information:

The substance has been registered as part of Metal lakes 2 group, consisting of two other similar substances, which are also under compliance check adoption. Compliance check requirements are being solved for three similar substances together, read-accross method included.

Reason / purpose for cross-reference:

read-across source

Key result

Dose descriptor:

NOAEL

Effect level:

>= 1 100 mg/kg bw/day (actual dose received)

Based on:

test mat.

Sex:

male/female

Remarks on result:

not determinable due to absence of adverse toxic effects

Key result

Critical effects observed:

no

Key result

Dose descriptor:

NOAEL

Generation:

F1

Effect level:

>= 1 110 mg/kg bw/day (actual dose received)

Based on:

test mat.

Sex:

male/female

Remarks on result:

not determinable due to absence of adverse toxic effects

Key result

Critical effects observed:

no

Key result

Reproductive effects observed:

no

Effect on fertility: via oral route

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

NOAEL

1 110 mg/kg bw/day

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

Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening study (OECD 422):

The test substance was administered orally via gavage to groups of 10 male and 10 female Wistar rats (F0 animals) at dose levels of 0 mg/kg bw/d (test group 0), 110 mg/kg bw/d (test group 1), 330 mg/kg bw/d (test group 2) and 1110 mg/kg bw/d (test group 3). Regarding clinical examinations, no signs of general systemic toxicity were observed in male or female parental animals of all test groups (110, 330 and 1110 mg/kg bw/d) during the entire study.
The duration of treatment covered a 2-week pre-mating and mating period in both sexes, approximately 1 week post-mating in males, and the entire gestation period as well as 4 days of lactation and two weeks thereafter in females.

A detailed clinical observation (DCO) was performed weakly in all animals. Food consumption and body weights of F0 parents were monitored throughout the study. Towards the end of the administration period clinicochemical and hematological examinations as well as urinalyses were performed in 5 animals per sex and group. Additionally, a functional observational battery was performed and motor activity was measured in 5 animals per sex and test group. All F0 parental animals were sacrificed by decapitation, under isoflurane anesthesia, and were assessed by gross pathology. Weights of selected organs were recorded and a histopathological examination was performed.

The pups were sexed and examined for macroscopically evident changes. They were weighed and their viability was recorded. At necropsy, all pups were sacrificed examined macroscopically for external and visceral findings.

No treatment-related, adverse effects were observed up to a dose of 1110 mg/kg bw/d regarding clinical pathology, pathology, fertility and reproductive performance.

Effects on developmental toxicity

Description of key information

Reproductive/Developmental Toxicity Screening Study: Read-across, NOAEL (fertility/develompent) >= 1 100 mg/kg bw/day, according to OECD 422, GLP-compliant, rat, 2012, K1

Link to relevant study records

Reference

Endpoint:

developmental toxicity

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Justification for type of information:

The substance has been registered as part of Metal lakes 2 group, consisting of two other similar substances, which are also under compliance check adoption. Compliance check requirements are being solved for three similar substances together, read-accross method included.

Reason / purpose for cross-reference:

read-across source

Key result

Dose descriptor:

NOAEL

Effect level:

>= 1 100 mg/kg bw/day (actual dose received)

Based on:

test mat.

Basis for effect level:

other: no effects observed

Key result

Abnormalities:

no effects observed

Key result

Dose descriptor:

NOAEL

Effect level:

>= 1 100 mg/kg bw/day (actual dose received)

Based on:

test mat.

Sex:

male/female

Basis for effect level:

other: no effects observed

Key result

Abnormalities:

no effects observed

Key result

Developmental effects observed:

no

Effect on developmental toxicity: via oral route

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

NOAEL

1 110 mg/kg bw/day

Study duration:

subacute

Species:

rat

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

Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening study (OECD 422):

The test substance was administered orally via gavage to groups of 10 male and 10 female Wistar rats (F0 animals) at dose levels of 0 mg/kg bw/d (test group 0), 110 mg/kg bw/d (test group 1), 330 mg/kg bw/d (test group 2) and 1110 mg/kg bw/d (test group 3). Regarding clinical examinations, no signs of general systemic toxicity were observed in male or female parental animals of all test groups (110, 330 and 1110 mg/kg bw/d) during the entire study.
The duration of treatment covered a 2-week pre-mating and mating period in both sexes, approximately 1 week post-mating in males, and the entire gestation period as well as 4 days of lactation and two weeks thereafter in females.

A detailed clinical observation (DCO) was performed weakly in all animals. Food consumption and body weights of F0 parents were monitored throughout the study. Towards the end of the administration period clinicochemical and hematological examinations as well as urinalyses were performed in 5 animals per sex and group. Additionally, a functional observational battery was performed and motor activity was measured in 5 animals per sex and test group. All F0 parental animals were sacrificed by decapitation, under isoflurane anesthesia, and were assessed by gross pathology. Weights of selected organs were recorded and a histopathological examination was performed.

The pups were sexed and examined for macroscopically evident changes. They were weighed and their viability was recorded. At necropsy, all pups were sacrificed examined macroscopically for external and visceral findings.

No treatment-related, adverse effects were observed up to a dose of 1110 mg/kg bw/d regarding clinical pathology, pathology, fertility and reproductive performance.

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. No adverse effects were observed in a screening study regarding fertility and developmental toxicity (OECD 422). 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 fifteenth time in Regulation (EC) No. 2020/1182.

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