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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Developmental toxicity / teratogenicity

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Administrative data

Endpoint:
developmental toxicity
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1994
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Remarks:
Data came from the SIDS dossier on CAS No. 81-11-8 that was accepted at SIAM 4 and posted on the OECD website.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
other: OECD preliminary reproduction toxicity screening test
GLP compliance:
yes
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
4,4'-diaminostilbene-2,2'-disulphonic acid
EC Number:
201-325-2
EC Name:
4,4'-diaminostilbene-2,2'-disulphonic acid
Cas Number:
81-11-8
Molecular formula:
C14H14N2O6S2
IUPAC Name:
2,2'-ethene-1,2-diylbis(5-aminobenzenesulfonic acid)
Details on test material:
Purity of the test material was 92.02%.

Test animals

Species:
rat
Strain:
Crj: CD(SD)
Details on test animals or test system and environmental conditions:
no data

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Details on exposure:
no data
Analytical verification of doses or concentrations:
not specified
Details on analytical verification of doses or concentrations:
no data
Details on mating procedure:
no data
Duration of treatment / exposure:
males: 41 days including 14 days before mating;
females: from 14 days before mating to day 3 of lactation
Frequency of treatment:
daily
Duration of test:
guideline compliant
No. of animals per sex per dose:
10
Control animals:
yes, concurrent vehicle
Details on study design:
no data

Examinations

Maternal examinations:
no data
Ovaries and uterine content:
no data
Fetal examinations:
no data
Statistics:
no data
Indices:
no data
Historical control data:
no data

Results and discussion

Results: maternal animals

Maternal developmental toxicity

Details on maternal toxic effects:
Maternal toxic effects: no effects

Details on maternal toxic effects: no data

Effect levels (maternal animals)

Dose descriptor:
NOAEL
Effect level:
>= 1 000 mg/kg bw/day (actual dose received)
Basis for effect level:
other: maternal toxicity

Results (fetuses)

Details on embryotoxic / teratogenic effects:
Embryotoxic / teratogenic effects:no effects

Details on embryotoxic / teratogenic effects:
no data

Effect levels (fetuses)

Dose descriptor:
NOAEL
Effect level:
>= 1 000 mg/kg bw/day (actual dose received)
Basis for effect level:
other: teratogenicity

Fetal abnormalities

Abnormalities:
not specified

Overall developmental toxicity

Developmental effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
The substance is considered not toxic to reproduction and is not teratogenic.
Executive summary:

The substance is considered not toxic to reproduction and is not teratogenic.