Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Acceptable, well-documented study report equivalent or similar to OECD guideline (403): GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report date:
1986

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
Alkenes, C6-11 (branched), hydroformylation products, distn. residues, heavy cracked fraction
Molecular formula:
CnH2n+2O2. n=24-33
IUPAC Name:
Alkenes, C6-11 (branched), hydroformylation products, distn. residues, heavy cracked fraction
Details on test material:
- Name of test material (as cited in study report): MRD-85-606
- Physical state: liquid

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female

Administration / exposure

Route of administration:
inhalation: aerosol
Type of inhalation exposure:
whole body
Vehicle:
other: unchanged (no vehicle)
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: glass chamber
- Exposure chamber volume: 1 cubic meter
- Method of holding animals in test chamber: individual cage
- Source and rate of air: room air, 250 lpm
- Method of conditioning air:
- System of generating particulates/aerosols: atomizer, 30 psi back pressure
- Method of particle size determination:
- Treatment of exhaust air:
- Temperature, humidity, pressure in air chamber:


TEST ATMOSPHERE
- Brief description of analytical method used: nominal basis: weighing the vessel containing the test material before and after the exposure and dividing the net loss in test material weight by the total volume of air passing through the chamber during the exposure. Actual basis: gravimetrically by drawing a known volume of chamber air through a pre-weighed glass-fiber filter. The filter was then re-weighed and the aerosol concentration calculated by dividing filter weight gain by the sample volume.
Analytical verification of test atmosphere concentrations:
yes
Remarks:
gravimetric samples
Duration of exposure:
ca. 4 h
Concentrations:
0 or 2.41 mg/ liter (SD 0.75)
No. of animals per sex per dose:
5/sex/group
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days, every 15 minutes for the first hour of exposure and at hourly intervals thereafter (up to 4 hours). Once removed from the chamber, daily observations were made for 14 days.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology
Statistics:
Means and standard deviations were calculated. Means for the two groups were compared by a two sample t-test. A standard F-test was used to determine if the variance of the groups was equal. If the variances were equal, testing was based on the t-test. If the variances were unequal, the Smith-Satterthwaite Correction for unequal variances was used.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 2.04 mg/L air (analytical)
Exp. duration:
4 h
Remarks on result:
other: All animals survived
Mortality:
0%
Clinical signs:
other: During the 14 day post exposure, incidences of material on the fur, hair loss, soft stool, and eye and nasal irritation were observed in the first 6 days. After the sixth day post-exposure, all animals of both sexes appeared normal.
Body weight:
No effect.
Gross pathology:
Three males and 5 females appeared free of any microscopic abnormalities. A dilated renal pelvis in the kidney of one male and reddened cervical lymph nodes and an absent right testicle in another male was observed.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The LC50 for the registered substance is > 2.04 mg/l.
Executive summary:

A group of rats, five per sex, were exposed for 4 hours to a liquid droplet aerosol of the registered substance at a gravimetrically determined mean concentration of 2.04 mg/l. A second comparable group of rats served as an unexposed control. Following the exposure, all animals were observed daily for 14 days. All animals survived the treatment. During the 14 day post exposure, incidences of material on the fur, hair loss, soft stool, and eye and nasal irritation were observed in the first 6 days. After the sixth day post-exposure, all animals of both sexes appeared normal. Based on these results, the 4 hours LC50 is > 2.04 mg/l.