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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
sub-chronic toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: A NTP study.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents)
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
140-30-4
IUPAC Name:
140-30-4
Constituent 2
Reference substance name:
Mercaptobenzothiazole
IUPAC Name:
Mercaptobenzothiazole

Test animals

Species:
rat
Strain:
Fischer 344
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Duration of treatment / exposure:
13 weeks
Frequency of treatment:
5 days/week
No. of animals per sex per dose:
10

Results and discussion

Effect levels

open allclose all
Dose descriptor:
LOAEL
Effect level:
750 mg/kg bw/day (nominal)
Based on:
test mat.
Dose descriptor:
NOAEL
Effect level:
375 mg/kg bw/day (nominal)
Based on:
test mat.

Target system / organ toxicity

Critical effects observed:
not specified

Any other information on results incl. tables

At 3000 mg/kg-day, all of the rats died. Due to the high mortality, the initial study was terminated and a second one was conducted using the same testing protocol with the omission of the highest dose level (3000 mg/kg-day). In the second study, no treatment-related deaths occurred. Body weight gains were lower than those in the vehicle control groups in males at 1500 mg/kg-day and in females at 750 or 1,500 mg/kg-day. Hepatomegaly occurred at 750 and 1500 mg/kg-day in males and at all doses in females; however, no microscopic pathologic changes were noted in any tissue. LOAEL = 750 mg/kg-day (based on decreased body weight gain in females) NOAEL = 375 mg/kg-day

Applicant's summary and conclusion

Conclusions:
LOAEL = 750 mg/kg-day (based on decreased body weight gain in females) NOAEL = 375 mg/kg-day
Executive summary:

Mercaptobezothiazole LOAEL = 750 mg/kg-day (based on decreased body weight gain in females) NOAEL = 375 mg/kg-day in 13 weeks study.