Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxic effect type:
dose-dependent

Effects on fertility

Description of key information

Rats were treated with 1,2-Dichloro-3-nitrobenzene in a Repeated Dose Toxicity study and Reproductive/Developmental Toxicity Screening Test (OECD 422). The rats were treated with 0 (vehicle), 1, 5, 25 or 100 mg/kg bw/day test substance. No adverse effects on reproduction and offspring were indicated. Based on the findings obtained, a NOAEL for fertility and offspring of 100 mg/kg bw/day and is suggested.

Link to relevant study records
Reference
Endpoint:
screening for reproductive / developmental toxicity
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well-documented study publication which meets basic scientific principles.
Qualifier:
according to guideline
Guideline:
OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
Deviations:
no
GLP compliance:
yes
Species:
rat
Strain:
Crj: CD(SD)
Sex:
male/female
Route of administration:
oral: gavage
Vehicle:
olive oil
Details on exposure:
admnistration period: male 44 days, females from day 14 before mating to day 3 of lactation.
Details on mating procedure:
no data given
Duration of treatment / exposure:
admnistration period: male 44 days, females from day 14 before mating to day 3 of lactation; terminal kill: male day 45; females: day 4 of lactation.
Frequency of treatment:
daily
Details on study schedule:
admnistration period: male 44 days, females from day 14 before mating to day 3 of lactation; terminal kill: male day 45; females: day 4 of lactation.
Remarks:
Doses / Concentrations:
0, 1, 5, 25, 100 mg/kg bw/day
Basis:

No. of animals per sex per dose:
5 per dose and sex
Control animals:
yes, concurrent vehicle
no adverse effects on fertility were indicated in treated animals
Dose descriptor:
NOAEL
Remarks:
fertility
Effect level:
100 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: no adverse effects on fertility
no adverse effects were indicated in offspring
Dose descriptor:
NOAEL
Generation:
F1
Effect level:
100 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: no adverse effects on offspring
Reproductive effects observed:
not specified

No adverse effects on fertility and offspring were indicated.

Executive summary:

Rats were treated with 1,2-Dichloro-3-nitrobenzene in a Repeated Dose Toxicity study and Reproductive/Developmental Toxicity Screening Test (OECD 422). The rats were treated with 0 (vehicle), 1, 5, 25 or 100 mg/kg bw/day test substance. No adverse effects on reproduction and offspring were indicated. Based on the findings obtained, a NOAEL for fertility and offspring of 100 mg/kg bw/day and is suggested.

Effect on fertility: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
100 mg/kg bw/day
Study duration:
subacute
Species:
rat
Quality of whole database:
Acceptable, well-documented study publication which meets basic scientific principles.
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available

Effects on developmental toxicity

Description of key information

Rats were treated with 1,2-Dichloro-3-nitrobenzene in a Repeated Dose Toxicity study and Reproductive/Developmental Toxicity Screening Test (OECD 422). The rats were treated with 0 (vehicle), 1, 5, 25 or 100 mg/kg bw/day test substance. No adverse effects on reproduction and offspring were indicated. Based on the findings obtained, a NOAEL for fertility and offspring of 100 mg/kg bw/day and is suggested.

Effect on developmental toxicity: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
100 mg/kg bw/day
Study duration:
subacute
Species:
rat
Quality of whole database:
Acceptable, well-documented study publication which meets basic scientific principles.
Effect on developmental toxicity: via inhalation route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via dermal route
Endpoint conclusion:
no study available

Toxicity to reproduction: other studies

Description of key information

No data.

Justification for classification or non-classification

Rats were treated with 1,2-Dichloro-3-nitrobenzene in a Repeated Dose Toxicity study and Reproductive/Developmental Toxicity Screening Test (OECD 422). The rats were treated with 0 (vehicle), 1, 5, 25 or 100 mg/kg bw/day test substance. No adverse effects on reproduction and offspring were indicated. Based on the findings obtained, a NOAEL for fertility and offspring of 100 mg/kg bw/day and is suggested. According to CLP classification criteria (Regulation (EC) No 1272/2008) a classification is not justified.

Additional information