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Toxicological information

Repeated dose toxicity: inhalation

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Administrative data

Endpoint:
chronic toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Published GLP study conducted for the National Toxicology Program
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1998

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
other: OECD Guideline 451 (Carcinogenicity Studies)
GLP compliance:
yes
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
The chemical, a clear colorless liquid, was identified as chloroprene by infrared, ultraviolet/visible, and nuclear magnetic resonance spectroscopy and by boiling point and density. The overall purity was determined to be approximately 96%.

For further details see cross reference to same study in chapter carcinogenicity

Test animals

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

Administration / exposure

Route of administration:
inhalation: vapour
Type of inhalation exposure:
whole body
Vehicle:
other: nitrogen
Analytical verification of doses or concentrations:
yes
Duration of treatment / exposure:
6 hours per day, 5 days per week, for 105 weeks; for further information see chapter carcinogenicity
Frequency of treatment:
Daily, 5 days per week
Doses / concentrations
Remarks:
Doses / Concentrations:
0, 12.8, 32 or 80 ppm
Basis:
nominal conc.
No. of animals per sex per dose:
50 rats/sex/group
Control animals:
yes, sham-exposed

Results and discussion

Effect levels

Dose descriptor:
LOAEC
Effect level:
12.8 ppm
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: the incidence of non-neoplastic lesions of the lungs (bronchiolar hyperplasia or alveolar epithelia hyperplasia) and of the nose (chronic inflammation; atrophy or necrosis) were increased

Target system / organ toxicity

Critical effects observed:
not specified

Any other information on results incl. tables

In this 2-year chronic inhalation bioassays conducted by NTP (1998), the incidence of non-neoplastic lesions of the lungs (bronchiolar hyperplasia or alveolar epithelia hyperplasia) and of the nose (chronic inflammation; atrophy or necrosis) were statistically increased in rats treated at the lowest exposure concentration in the study (12.8 ppm). a No-Observed-Adverse-Effect-Concentration (NOAEC) was not identified in the study.

For further details and neoplastic observations see cross reference to same study in chapter carcinogenicity.

Applicant's summary and conclusion

Conclusions:
In this 2-year chronic inhalation bioassays conducted by NTP (1998), the incidence of non-neoplastic lesions of the lungs (bronchiolar hyperplasia or alveolar epithelia hyperplasia) and of the nose (chronic inflammation; atrophy or necrosis) were statistically increased in rats treated at the lowest exposure concentration in the study (12.8 ppm). a No-Observed-Adverse-Effect-Concentration (NOAEC) was not identified in the study.