Registration Dossier

Toxicological information

Acute Toxicity: inhalation

Currently viewing:

Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
read-across based on grouping of substances (category approach)
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given.
Justification for type of information:
The Glycol ester category covers esters of an aliphatic diol (ethylene glycol (EG), propylene glycol (PG) or 1,3-butyleneglycol (1,3-BG)) and one or two carboxylic fatty acid chains. The fatty acid chains comprise carbon chain lengths ranging from C6 to C18, mainly saturated but also mono unsaturated C16 and C18, branched C18 and epoxidized C18.
 
The available data allows for an accurate hazard and risk assessment of the category and the category concept is applied for the assessment of environmental fate and environmental and human health hazards. Thus, where applicable, environmental and human health effects are predicted from adequate and reliable data for source substance(s) within the group by interpolation to the target substances in the group (read-across approach) applying the group concept in accordance with Annex XI, Item 1.5, of Regulation (EC) No 1907/2006. In particular, for each specific endpoint the source substance(s) structurally closest to the target substance is/are chosen for read-across, with due regard to the requirements of adequacy and reliability of the available data. Structural similarities and similarities in properties and/or activities of the source and target substance are the basis of read-across.
A detailed justification for the grouping of chemicals and read-across is provided in the technical dossier (see IUCLID Section 13).

Data source

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

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Deviations:
yes
Remarks:
duration of exposure 6 h, purity of the test material not specified, only male animals were used.
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
Decanoic acid, mixed diesters with octanoic acid and propylene glycol
EC Number:
271-516-3
EC Name:
Decanoic acid, mixed diesters with octanoic acid and propylene glycol
Cas Number:
68583-51-7

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Blue Spruce Farms, Inc., Altamont, NY, USA
- Age at study initiation: young adults
- Weight at study initiation: 145 - 195 g
- Housing: individually housed in mesh bottom cages
- Diet: ad libitum
- Water: ad libitum

Administration / exposure

Route of administration:
inhalation: aerosol
Type of inhalation exposure:
whole body
Vehicle:
air
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure chamber volume: 75 L
- Method of particle size determination: every 30 min using a Bausch and Lomb particle counter (model 40-1A)

- Each group of rats was placed in a 75 L chamber equipped with an air supply of 10 L per minute. After the test animals became accustomed to the chamber conditions, the material was sprayed into the air supply at a rate calculated to yield the required concentration of 200 ppm.
- The chamber temperature was recorded every 30 min.
- The control group was exposed only to air for the same length of time.
Analytical verification of test atmosphere concentrations:
yes
Remarks:
Particle counts were performed every 30 min using a Bausch and Lomb particle counter (model 40-1A)
Duration of exposure:
6 h
Concentrations:
200 ppm
equal to 2.916 mg/L air (MW = 356.55 g/mol)
No. of animals per sex per dose:
3 (controls), 10 (test substance groups)
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 7 days
- Frequency of observations: daily
- Necropsy of survivors performed: yes
- Other examinations performed: all major tissues and organs were preserved and the lungs and grossly abnormal organs were examined microscopically.

Results and discussion

Effect levelsopen allclose all
Sex:
male
Dose descriptor:
LC50
Effect level:
> 200 ppm
Based on:
test mat.
Exp. duration:
6 h
Sex:
male
Dose descriptor:
LC50
Effect level:
> 2.916 mg/L air (nominal)
Based on:
test mat.
Exp. duration:
6 h
Remarks on result:
other: based on a molecular weight of 356.55 g/mol
Mortality:
No mortality occurred during the study period.
Clinical signs:
other: No clinical signs of toxicity were observed up to the end of the 7-day observation period.
Gross pathology:
Necropsy examination revealed no substance-related findings.

Any other information on results incl. tables

According to the authors, respirable particles of the test material (≤ 5 µm) were produced.

Applicant's summary and conclusion

Interpretation of results:
other: inconclusive
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
CLP: inconclusive
DSD: inconclusive