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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Endpoint:
short-term repeated dose toxicity: inhalation
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Study period:
year of publication: 1974
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: insufficiently documented literature data, details on study design and results are missing

Data source

Reference
Reference Type:
publication
Title:
Industrial experience with 3,3'-dichlorobenzidine. An epidemiological study of a chemical manufacturing plant.
Author:
Gerarde HW, Gerarde DF
Year:
1974
Bibliographic source:
J. Occup. Med. 16: 322-344
Report date:
1974

Materials and methods

Principles of method if other than guideline:
subacute inhalative toxicity test
GLP compliance:
no
Limit test:
no

Test material

Constituent 1
Reference substance name:
3,3'-dichlorobenzidine
EC Number:
202-109-0
EC Name:
3,3'-dichlorobenzidine
Cas Number:
91-94-1
IUPAC Name:
3,3'-dichlorobiphenyl-4,4'-diamine

Test animals

Species:
rat
Strain:
not specified
Sex:
male

Administration / exposure

Route of administration:
inhalation
Type of inhalation exposure:
whole body
Vehicle:
air
Analytical verification of doses or concentrations:
no
Duration of treatment / exposure:
2 hours/day for seven days
Frequency of treatment:
2 hours/day for seven days
Doses / concentrations
Remarks:
Doses / Concentrations:
15 L chamber into which 355 mg were blown during the 2h period
Basis:

No. of animals per sex per dose:
10 males
Control animals:
no
Details on study design:
Animals were exposed in a 15 liter chamber into which 355 mg of the test material were blown.
Positive control:
no

Results and discussion

Target system / organ toxicity

Critical effects observed:
not specified

Any other information on results incl. tables

No adverse effects were detected during the 7 day exposure period. The animals continued to gain weight during the exposure duration.

Applicant's summary and conclusion

Executive summary:

When exposing 10 rats 2 h/day for seven days to 355 mg of test material blown into a 15 l chamber during the 2 h period animals continue to gain weight and were not uncomfortable. No advers effects could be detected.