N-(4-amino-9,10-dihydro-3-methoxy-9,10-dioxo-1-anthryl)benzenesulphonamide

Endpoint summary

Key value for chemical safety assessment

Toxic effect type:

dose-dependent

Effects on fertility

Description of key information

On the basis of this reproduction/developmental toxicity screening test with FAT 36034/W TE in male and female Wistar rats with dose levels of 100, 300, and 1000 mg/kg/d conducted according to OECD 422 guideline (GLP-compliant), based on the data generated from this combined repeated dose oral toxicity and reproduction/ developmental toxicity screening test with FAT 36014/W TE, the no observed adverse effect level (NOAEL) is considered to be 1000 mg/kg/d for for reproduction/ developmental toxicity.

Link to relevant study records

Reference

Endpoint:

screening for reproductive / developmental toxicity

Remarks:

Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test

Type of information:

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

Adequacy of study:

key study

Justification for type of information:

Refer chapter 13 for detailed read across justification.

Reason / purpose for cross-reference:

read-across source

Species:

rat

Strain:

Wistar

Dose / conc.:

100 mg/kg bw (total dose)

Remarks:

Low Dose

Dose / conc.:

300 mg/kg bw (total dose)

Remarks:

Medium dose

Dose / conc.:

1 000 mg/kg bw (total dose)

Remarks:

High dose

Key result

Dose descriptor:

NOAEL

Effect level:

1 000 mg/kg bw (total dose)

Based on:

test mat.

Sex:

male/female

Basis for effect level:

histopathology: non-neoplastic

reproductive function (oestrous cycle)

reproductive function (sperm measures)

reproductive performance

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 effects

Critical effects observed:

no

Reproductive effects observed:

no

Conclusions:

Based on the read across data generated from the the combined repeated dose oral toxicity and reproduction/ developmental toxicity screening test with FAT 36034/W, the no observed adverse effect level (NOAEL) is considered to be 1000 mg/kg/d for reproduction/ developmental toxicity.

Executive summary:

Data on reproduction/developmental toxicity study was not available for the target substance. To fill the data gaps, read across approach is adapted using similar substance FAT 36034/W. Read-across is claimed basis of structural relationship of the target and the source chemicals. Read across substance is FAT 36034/W and have been investigated for reproduction/developmental toxicity. On the basis of this reproduction/developmental toxicity screening test with FAT 36034/W TE in male and female Wistar rats with dose levels of 100, 300, and 1000 mg/kg/d conducted as per OECD 422 guideline (GLP compliance), based on the data generated from this combined repeated dose oral toxicity and reproduction/ developmental toxicity screening test with FAT 36034/W, the no observed adverse effect level (NOAEL) is considered to be 1000 mg/kg/d for for reproduction/ developmental toxicity.

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

Quality of whole database:

Quality data, study was conducted under GLP environment

Justification for classification or non-classification

On the basis of this reproduction/developmental toxicity screening test with FAT 36034/W TE in male and female Wistar rats with dose levels of 100, 300, and 1000 mg/kg/d conducted according to OECD 422 guideline (GLP-compliant), based on the data generated from this combined repeated dose oral toxicity and reproduction/ developmental toxicity screening test with FAT 36014/W TE, the no observed adverse effect level (NOAEL) is considered to be 1000 mg/kg/d for for reproduction/ developmental toxicity.