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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Repeated dose toxicity: inhalation

Currently viewing:

Administrative data

Endpoint:
sub-chronic toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
2012
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
A reliable secondary source, summarising 2-mercaptobenzimidazole properties, was used. However the primary sources were not revisited in order to verify their contents; for this reason reliability score 2 was used. The used secondary source has been updated on 2012; therefore it covers the most updated literature on the substance.

Data source

Reference
Reference Type:
secondary source
Title:
Prechronic inhalation toxicity studies of 2mercaptobenzimidazole (2MBI) in F344/N rats.
Author:
Gaworski CL, Aranyi C, Vana S, Rajendran N, Abdo K, Levine BS, Hall A 3rd.
Year:
1991
Bibliographic source:
PubMed - Fundam Appl Toxicol. 1991 Jan;16(1):161-71.

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
It is not specified
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Benzimidazole-2-thiol
EC Number:
209-502-6
EC Name:
Benzimidazole-2-thiol
Cas Number:
583-39-1
Molecular formula:
C7H6N2S
IUPAC Name:
1H-benzimidazole-2-thiol
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder

Test animals

Species:
rat
Strain:
Fischer 344
Sex:
not specified

Administration / exposure

Route of administration:
inhalation
Type of inhalation exposure:
not specified
Vehicle:
not specified

Results and discussion

Results of examinations

Details on results:
Exposure-related histopathologic changes included pituitary cytoplasmic vacuolization, adrenal cortex necrosis, lymphoid depletion, thymic atrophy, liver cell hypertrophy, renal mineralization and tubular atrophy, and hypocellularity of the bone marrow.

Effect levels

open allclose all
Dose descriptor:
dose level:
Effect level:
>= 25 mg/m³ air
Based on:
test mat.
Sex:
not specified
Basis for effect level:
other: see 'Remark'
Dose descriptor:
dose level:
Effect level:
>= 6.2 mg/L air
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: Increased thyroid weight and thyroid follicular cell hyperplasia
Dose descriptor:
dose level:
Effect level:
ca. 3.1 mg/L air
Based on:
test mat.
Sex:
not specified
Basis for effect level:
other: Thyroid follicular cell hyperplasia was also seen in rats at 3.1 mg/m3

Target system / organ toxicity

Critical effects observed:
not specified

Any other information on results incl. tables

2-Mercaptobenzimidazole (2-MBI), used in rubber processing, is a suspect carcinogen structurally related to ethylene

thiourea. The inhalation toxicity of 2-MBI was evaluated in male and female F344/N rats exposed 6 hr/day, 5 days/week

to respirable aerosols generated by spray atomization of aqueous suspensions of the 2-MBI powder and subsequent

drying of the resulting aerosols. Twelve exposures at target concentrations of 0, 6.3, 12.5, 25.0, 50.0, or 100 mg/m3 of

2-MBI produced a dose-related reduction in body weight gains, thyroid follicular cell hyperplasia, adrenal cortex fatty

change, and pituitary atrophy. Sub-chronic exposures were conducted at target concentrations of 0, 3.1, 6.2, 12.5, 25.0,

and 50.0 mg/m3 of 2-MBI. Rats at greater than or equal to 25 mg/m3 displayed hunched posture, hypoactivity, and

reduced body weight gain, with compound related mortality at the highest exposure level. Anemia; increased SGPT,

SGOT, alkaline phosphatase, sorbitol dehydrogenase, BUN, and cholesterol; and reduced free fatty acid were seen in

rats at greater than or equal to 25 mg/m3. Increased thyroid weight and thyroid follicular cell hyperplasia were noted in

both sexes at greater than or equal to 6.2 mg/m3, with reduced triiodothyronine and thyroxine levels in both sexes at

greater than or equal to 12.5 mg/m3. Thyroid follicular cell hyperplasia was also seen in rats at 3.1 mg/m3. Thymus

weights were significantly reduced in both sexes at all exposure levels with liver weight increases at greater than or

equal to 6.2 mg/m3. Exposure-related histopathologic changes included pituitary cytoplasmic vacuolization, adrenal

cortex necrosis, lymphoid depletion, thymic atrophy, liver cell hypertrophy, renal mineralization and tubular atrophy, and

hypocellularity of the bone marrow.

Applicant's summary and conclusion

Conclusions:
According to Directive 67/548/EEC and to Regulation (EC) n. 1272/2008, the substance should be classified for specific target organ toxicity after repeated exposure.