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Toxicological information

Repeated dose toxicity: inhalation

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Administrative data

Endpoint:
short-term repeated dose toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
No data
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
abstract
Remarks:
not all information could be retrieved from the study report

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report Date:
1979

Materials and methods

Test guideline
Qualifier:
no guideline available
GLP compliance:
not specified
Remarks:
pre GLP
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Wistar
Sex:
male

Administration / exposure

Route of administration:
inhalation
Type of inhalation exposure:
nose only
Vehicle:
other: no data
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
14 days
Frequency of treatment:
5 hours/day 6 times in 14 days
Doses / concentrations
Dose / conc.:
94 mg/m³ air
No. of animals per sex per dose:
No data
Control animals:
yes
Details on study design:
Post-exposure period: 4 weeks

Results and discussion

Effect levels

Dose descriptor:
LOAEC
Effect level:
94 mg/m³ air
Sex:
male

Target system / organ toxicity

Critical effects observed:
not specified

Any other information on results incl. tables

All dosed animals showed a moderate to high grade subacute or chronic laryngitis, immediately after exposure, and after the four week recovery period. During the recovery period, the laryngitis appeared milder but the presence of foreign body giant cells indicated an incomplete elimination of the test compound.  It was not possible to determine the nature of
the residues responsible for the chronic laryngitis. Immediately after treatment all test animals exhibited moderate inflammation in certain parts of the larynx, which did not completely recover during the post-exposure four week observation period.

Applicant's summary and conclusion

Conclusions:
In a subacute inhalation study, Wistar rats were exposed, nose-only, to the test substance at a concentration of 94 mg/m3, five hours a day,at six days within 14 days. A NOAEC could not be established as inflammation of the larynx was observed immediately following treatment and at the end of the observation period.
Executive summary:

In a subacute inhalation study, Wistar rats were exposed, nose-only, to the test substance at a concentration of 94 mg/m3, five hours a day,at six days within 14 days. All dosed animals showed a moderate to high grade subacute or chronic laryngitis, immediately after exposure, and after the four week recovery period. During the recovery period, the laryngitis appeared milder but the presence of foreign body giant cells indicated an incomplete elimination of the test compound. It was not possible to determine the nature of the residues responsible for the chronic laryngitis. Immediately after treatment all test animals exhibited moderate inflammation in certain parts of the larynx, which did not completely recover during the post-exposure four four week observation period.