Registration Dossier

Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
1978
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: limited report, non-GLP, not all parameters investigated, exposure duration only 1 hour. The information in the report is limited to the information in the summary.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report Date:
1978

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: FHSLA, CFR, Title 21, para. 191.10
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid: viscous

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: not indicated
- Weight at study initiation: males: 235-291 g; females 225 -292 g
- Fasting period before study: NA
- Housing: group
- Diet: ad libitum
- Water: ad libitum:
- Acclimation period: not indicated

ENVIRONMENTAL CONDITIONS: no information available

Administration / exposure

Route of administration:
inhalation
Type of inhalation exposure:
not specified
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION: no data available
The substance was vapourized according to the report. However in view of the low vapour pressure of both the test substance and the diluent oil (very viscous formulation), it seems more likely that an aerosol was generated

TEST ATMOSPHERE (if not tabulated): no data
Analytical verification of test atmosphere concentrations:
no
Duration of exposure:
ca. 1 h
Concentrations:
7.6 mg/L (calculation based on concentration)
No. of animals per sex per dose:
5 males + 5 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily for clinical signs and mortality; frequency of weighing not indicated (only starting weight reported)
- Necropsy of survivors performed: no
- Other examinations performed: clinical signs
Statistics:
NA

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 7.6 mg/L air (nominal)
Based on:
act. ingr.
Exp. duration:
1 h
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 19 mg/L air (nominal)
Based on:
test mat.
Exp. duration:
1 h
Mortality:
none
Clinical signs:
other: none reported
Body weight:
no data
Gross pathology:
not performed

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The LC50 for the test substance is > 7.6 mg/L
Executive summary:

Rats (5/sex) were exposed to the test substance at 7.6 mg/L by inhalation during 1 hour. No mortality or clinical signs were observed during the 14 day observation period. It is therefore concluded that the LC50 is >7.6 mg/L