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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

Description of key information

Read-across: Equivalent to OECD 421; GLP; male/female Wistar rats; oral (gavage); 160, 400, and 1000 mg/kg bw/day; 28 – approx. 56 days; daily administration; no adverse effects observed; NOAEL male/female 1000 mg/kg bw/day

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:
See read-across justification
Reason / purpose for cross-reference:
read-across source
Dose descriptor:
NOAEL
Effect level:
1 000 mg/kg bw/day (actual dose received)
Based on:
other: read-across
Sex:
male/female
Basis for effect level:
other: no effects assumed
Critical effects observed:
no
Dose descriptor:
NOAEL
Generation:
F1
Effect level:
1 000 mg/kg bw/day (actual dose received)
Based on:
other: read-across
Sex:
male/female
Basis for effect level:
other: no effects assumed
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 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

Read across justification

The test item was not analyzed for its potential to influence reproduction and development. Experimental data of a structural analogue are available. Both substances are calcium salts of sulphonatophenyl-pyrazol-azobenzenesulfonic acid of low solubility in water and octanol. In addition, both substances have a molecular weight higher than 500 g/mol which decreases gastro intestinal absorption and systemic bioavailability (a detailed read across justification is given in CSR, Annex I).

Procedure and observations

A Reproduction / Developmental Toxicity screen was conducted to determine possible influence on fertility and teratogenicity. The analogue substance was administered by gavage at concentrations of 0,160, 400 and 1000 mg/kg bw/day to male and female Wistar rats (12/sex/dose). Males were treated totally for 28d, females were treated until 3rd day of lactation.

The test material did not influence fertility or reproduction of the test animals. Atrophic changes in prostate gland of parental males of the high dose group were observed. This effect did not negatively influence fertility of parental males.

Discussion

Administration of an analogue test substance up to 1000 mg/kg bw did not induce mortalities, clinical signs or changes in body weight or food consumption. Mating behavior, fertility, gestation and lactation were not influenced by the test item. A decrease of the absolute and relative weight of the prostate gland was recorded in males of all dose levels (dose-independent). The histological examination demonstrated the increased occurrence of atrophic changes in prostate gland of males at the dose level 1000 mg/kg/day (without negative influence on fertility of parental males). Yellow-colored feces of males and females at dose levels 400 and 1000 mg/kg bw/day, discolored cecum and stomach in males and yellow-colored intestine and stomach contents without changes of structure of these organs were reported during pathological examinations of males and females at 1000 mg/kg bw/day and 400 and 1000 mg/kg bw/day, respectively. Therefore, the test material is not considered to be toxic to reproduction or the developing offspring. Thus, the NOAEL for reproduction and development was 1000 mg/kg bw/day for both parental animals and offspring. The NOAEL for general toxicity, based on atrophic changes in the prostate, was considered to be 400 mg/kg bw/day.


Short description of key information:
Experimental data of a read across substance (methylated calcium salt) are used to evaluate the reprotoxic potential of the test item. A screening assay was conducted to determine toxicity to reproduction and development (OECD guideline 421, GLP). The structural analogue did not influence fertility of parental animals or development of the offspring. The NOAEL for fertility was considered to be 1000 mg/kg bw/day.

Effects on developmental toxicity

Description of key information

Read-across: Equivalent to OECD 421; GLP; male/female Wistar rats; oral (gavage); 160, 400, and 1000 mg/kg bw/day; 28 – approx. 56 days; daily administration; no adverse effects observed; NOAEL offspring 1000 mg/kg bw/day

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:
See read-across justification
Reason / purpose for cross-reference:
read-across source
Dose descriptor:
NOAEL
Effect level:
1 000 mg/kg bw/day (actual dose received)
Based on:
other: read-across
Basis for effect level:
other: no effects assumed
Abnormalities:
no effects observed
Dose descriptor:
NOAEL
Effect level:
1 000 mg/kg bw/day (actual dose received)
Based on:
other: read-across
Sex:
male/female
Basis for effect level:
other: no effects assumed
Abnormalities:
no effects observed
Developmental effects observed:
no
Effect on developmental toxicity: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
1 000 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

Read across justification

The test item was not analyzed for its potential to influence reproduction and development. Experimental data of a structural analogue are available. Both substances are calcium salts of sulphonatophenyl-pyrazol-azobenzenesulfonic acid of low solubility in water and octanol. In addition, both substances have a molecular weight higher than 500 g/mol which decreases gastro intestinal absorption and systemic bioavailability (full read across justification in CSR, Annex I).

Procedure and observations

A Reproduction / Developmental Toxicity screen was conducted to determine possible influence on fertility and teratogenicity. The test item was administered by gavage at concentrations of 0,160, 400 and 1000 mg/kg bw/day to male and female Wistar rats (12/sex/dose). Males were treated totally for 28d, females were treated until 3rd day of lactation. As a result, the ability of male and female animals to successfully mate and produce viable offspring was unaffected by the test substance treatment. Also development of pups was not changed in treatment groups.

Discussion

Administration of the analogue substance did not affect number, viability and development of the offsping, also teratogenicity was not observed. Thus, the substance is not considered to own developmental toxicity

Justification for classification or non-classification

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

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is not considered to be classified for reproductive toxicity under Regulation (EC) No. 1272/2008, as amended for the thirteenth time in Commission Regulation (EU) 2018/1480 of Oct 4, 2018.

Additional information