Registration Dossier

Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
april 1976-april 1977
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to Guideline study with acceptable restrictions.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
Toxicology Division Procedural Guide, US Army Environmental Hygiene Agency (USAEHA), 1972
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): Ethyl centralite- Physical state: pulverized white powder- Lot/batch No.: 1123

Test animals

Species:
rat
Sex:
male

Administration / exposure

Route of administration:
inhalation
Duration of exposure:
8 h
Remarks on duration:
single exposure
Concentrations:
nominal concentration - 0.4, 198 mg/L
No. of animals per sex per dose:
6 males
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days- Body weight: pre-exposure day, post-exposure day 1, 3 ,7, 11- Necropsy of survivors performed: yes- Other examinations performed: body weight,organ-to-body weight ratios weights, histopathology

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LC50
Effect level:
> 198 mg/L air (nominal)
Based on:
test mat.
Exp. duration:
8 h

Any other information on results incl. tables

TEMPERATURE 23°C

Results: Rats exposed to a nominal concentration of 0.4 mg/L for 8 hours showed no toxic signs during exposures and for 14 days thereafter. Body weight gain and organ-to-body weight ratios of the exposed rats compared to the control rats were not significantly different. No exposure related histopathologic changes were noted in tissues and organs.

Interpretation: Compound has a low volatility and should present no acute inhalation hazard from single short term exposure.

TEMPERATURE 50°C

Results: No discernible loss of test material from dispersion tube was found. Rate showed no toxic signs during exposure and 14 days thereafter. Body weight gain and the organ-to-body weight ratios of liver, kidney, lung, spleen and testes from exposed rats compared to the control rats were not significantly different. No exposure related histopathological changes were noted in tissues and organs.

Interpretation: Compound has a low volatility and should present no hazard at room temperature due to the inhalation of ethyl centralite vapors.

TEMPERATURE 100°C

Results: Compound melted and vaporized from dispersion tube into exposure chamber, all compound had been dispersed in 80 minutes at a concentration 198 mg/L. Rats showed no toxic signs during exposure and 14 days thereafter. Body weight gain and the organ-to-body weight ratios of the exposed rats compared to the control rats were not significantly different. No exposure related histopathological changes were noted in tissues and organs.

Interpretation: Vapor presents no acute inhalation hazard from single short term exposure.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated informationCriteria used for interpretation of results: EU
Conclusions:
Acute vapor inhalation exposures of rats resulted experimentally in no deleterious effect. These results show that ethyl centralite has a low volatility and should present no hazard due to inhalation ot its vapors at room temperature. Also, if vapors are present, acute inhalation from a single exposure presemts no hazard.