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Diss Factsheets

Toxicological information

Acute Toxicity: inhalation

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Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
disregarded due to major methodological deficiencies
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: Non-GLP study for Epoxide 8 which has different exposure route concern comparing with the target material. Exposure concentrations were not measured. Limited documentation. Thus the study is used for read-across to avoid duplicate tests.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1968
Report date:
1968

Materials and methods

Principles of method if other than guideline:
The test material was sprayed undiluted for fifteen seconds into an inhalation chamber containing four rabbits and ten rats. The chamber was sealed and flushed with air under reduced pressure for one hour. This procedure was repeated three times daily for
two days for the test material.
Necropsies were performed on each group of animals the morning following the last treatment. Blood and tissues were taken for examination.
GLP compliance:
no
Test type:
fixed concentration procedure

Test material

Constituent 1
Reference substance name:
Epoxide 8
IUPAC Name:
Epoxide 8
Details on test material:
No data

Test animals

Species:
rat
Strain:
CD-1
Details on test animals or test system and environmental conditions:
Ten (10) Charles River CD Rats and four (4) New Zealand Albino Rabbits.

Administration / exposure

Route of administration:
inhalation
Type of inhalation exposure:
whole body
Vehicle:
air
Details on inhalation exposure:
The test material was sprayed undiluted for fifteen seconds into an inhalation chamber containing four rabbits and ten rats. The chamber was sealed and flushed with air under reduced pressure for one hour. This procedure was repeated three times daily for two days for the test material.
Analytical verification of test atmosphere concentrations:
no
No. of animals per sex per dose:
10 rats and 4 rabbits

Results and discussion

Effect levels
Remarks on result:
other: No changes were found which related to the test treatment
Mortality:
No deaths
Clinical signs:
other: No symptoms noted
Body weight:
Average body weights were normal
Gross pathology:
No lesions were noted grossly in either species exposed to Epoxide No.8.
Other findings:
Microscopic examination of tissues showed no unusual changes except myocarditis in all four rabbits. The myocarditis was considered unrelated to test treatment since the population of rabbits being used had a higher than normal incidence of myocarditis.
Average blood values and organ/body weight-ratios were normal.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Epoxide No. 8 does not pose any apparent inhalation problem since it has a low toxicity and vapour pressure.
Executive summary:

The test material was sprayed undiluted for fiftheen seconds into an inhalation chamber containing four rabbits and ten rats. The chamber was sealed and flushed with air under reduced pressure for one hour. This procedure was repeated three times daily for two days for the test. material. Necropsies were performed on each group of animals the morning following the last treatment. Blood and tissues were taken for examination.

No lesions were noted grossly in either species exposed to Epoxide No.8. Microscopic examination of tissues showed no unusual changes except myocarditis in all four rabbits. The myocarditis was considered unrelated to test treatment since the population of rabbits being used had a higher than normal incidence of myocarditis. Average blood values and organ/body weight-ratios were normal.

Epoxide No. 8 does not pose any apparent inhalation problem since it has a low toxicity and vapour pressure.