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Diss Factsheets

Administrative data

acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 21st of October to 6th of November 2014
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Well documented GLP study performed according to OECD Guideline 403 and US EPA OPPTS Guidelien 870.1300.

Data source

Reference Type:
study report
Report date:

Materials and methods

Test guidelineopen allclose all
according to guideline
OECD Guideline 403 (Acute Inhalation Toxicity)
according to guideline
EPA OPPTS 870.1300 (Acute inhalation toxicity)
GLP compliance:
yes (incl. QA statement)
Test type:
standard acute method
Limit test:

Test material

Constituent 1
Chemical structure
Reference substance name:
EC Number:
EC Name:
Cas Number:
Molecular formula:
Details on test material:
- Name of test material (as cited in study report): JEFFSOL glycerine carbonate
- Substance type: Light yellow liquid
- Physical state: Liquid
- Analytical purity: 96.6%
- Composition of test material, percentage of components: 1.7% glycerine, 96.6% glycerine carbonate, total carbonate 98.3% and water content 0.04%
- Purity test date: 31-12-2013
- Lot/batch No.: BLW0008870
- Expiration date of the lot/batch: 20 November 2014
- Storage condition of test material: at room temperature, away from direct sunlight

Test animals

Details on test animals or test system and environmental conditions:
- Source: Charles River Laboratories, Raleigh, NC
- Age at study initiation: approximately 9 weeks old
- Weight at study initiation: males: 313 to 322 g; females: 190 to 239 g
- Fasting period before study: during acclimation to the nose-only restraint
- Housing: upon arrival in individually in suspended wire-mesh cages; on the day of exposure: nose-only exposure holding tubes in the exposure room and returned to their home cages after exposure
- Diet (e.g. ad libitum): ad libitum except during acclimation to the nose-only restraint and during exposure periods
- Water (e.g. ad libitum): ad libitum except during acclimation to the nose-only restraint and during exposure periods
- Acclimation period: minimum of 5 days

- Temperature (°C): +/- 22 ± 3°C (21.3 to 22.4°C in this study)
- Humidity (%): 50% ± 20% relative humidity (31.8 to 52.4% in this study)
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
inhalation: aerosol
Type of inhalation exposure:
nose only
other: dry, breathing quality, in-house, compressed air
Details on inhalation exposure:
- Exposure apparatus: 6-jet collison nebulizer (nose-only exposure system with synthetic rubber grommets in exposure ports to engage the animal holding tubes)
- Exposure chamber volume: 7.9 L
- Method of holding animals in test chamber: animals were restrained in nose-only holding tubes
- Source and rate of air: Dry, breathing quality, in-house, compressed air at a controlled pressure was supplied to the nebulizer using a regulator to effect atomization of the test substance. The resulting aerosol was delivered to the nose-only exposure system through 22-mm respiratory tubing. A tee fitting was placed in-line prior to the nose-only exposure system where supply/dilution air was added as needed, and mixed with the concentrated test substance aerosol atmosphere to achieve the desired exposure concentration. Supply/dilution air from the in-house supply air system was controlled using a rotameter-type flowmeter. Exposure system airflows: Nebulizer airflow: 29.3-30.3 LPM, supply/dilution airflow: 0-6.5 LPM, total airflow: 29.3-36.8 LPM
- Method of particle size determination: aerosol particle size measurements: Two aerosol particle size measurements were conducted during the exposure using a 7-stage cascade impactor. Pre-weighed 25 mm glass-fiber filters were used as the collection substrates. Samples were collected at 1.8 L/min for 0.25 minutes. The filters were re-weighed and the particle size was calculated based on the impactor stage cut-offs. The aerosol size was expressed as the mass median aerodynamic diameter and the geometric standard deviation.
- Treatment of exhaust air: Exhaust atmosphere was filtered using a Solberg filter prior to entering the facility exhaust system, which consisted of charcoal-and HEPA-filtration.
- Temperature, humidity, pressure in air chamber: Exposure atmosphere environmental conditions were recorded at approximately 60-minute intervals during the exposures. A temperature and relative humidity transmitter probe and display unit was used to monitor temperature and percent relative humidity. Actual mean daily temperature ranged from 70.4°F to 72.4°F (21.3°C to 22.4°C) and mean daily relative humidity ranged from 38.1% to 52.4% during the study. Air handling units were set to provide a minimum of 10 fresh air changes per hour, 100% fresh air.

- Brief description of method used for the determination of the actual exposure concentration: Actual exposure concentrations were determined approximately every 30-45 minutes using standard gravimetric methods. Samples were collected on pre-weighed, 25-mm glass-fiber filters held in an open-faced filter holder positioned in the animal exposure port (i.e., in the breathing zone of the animal) of the nose-only exposure system. A measured volume of the exposure atmosphere was pulled through the filter to quantitatively collect aerosol particles. Following sample collection, the filters were re-weighed and the concentration calculated as the filter weight difference divided by the sample volume. Samples were collected at a flowrate of approximately 33-35 mL/minute for 10 minutes.
- Samples taken from breathing zone: yes

TEST ATMOSPHERE (if not tabulated)
- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.): Mean MMAD: 2.4 µm; Mean GSD: 1.92 determined at a test dose concentration of 2 mg/L
Analytical verification of test atmosphere concentrations:
however standard gravimetric methods are used to determine the actual exposure concentration
Duration of exposure:
4 h
Range-finding exposure: 5.4 mg/L
Definitive study: 5.6 mg/L
No. of animals per sex per dose:
Range-finding exposure: 1 rat/sex
Definitive study: 5 animals/sex
Control animals:
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Mortality: Each animal was observed for mortality at the approximate midpoint of exposure and twice daily thereafter for 14 days (once in the morning and once in the afternoon, except on the day of scheduled necropsy).
Clinical observations: Each animal was observed immediately following exposure on study day 0, once 1-2 hours following exposure, and once daily thereafter during 14 days for clinical signs of toxicity. Observations were recorded at approximately the same time each day and included, but were not limited to: changes in the skin and fur, eyes and mucous membranes and also changes to the respiratory, circulatory, autonomic and central nervous system, somatomotor activity and behavior pattern.
Body weights: Body weights were obtained prior to exposure on study day 0 and on post-exposure days 1, 3, 7, and 14.
- Necropsy of survivors performed: yes, animals at the scheduled necropsy were euthanized by isoflurane anesthesia followed by exsanguination. The major organ systems of the cranial, thoracic, and abdominal cavities were examined for all animals. No tissue or organs were retained and the carcasses were discarded after necropsy.

Results and discussion

Effect levels
Dose descriptor:
Effect level:
> 5.6 mg/L air
Based on:
test mat.
Exp. duration:
4 h
None of the animals died during exposure or during the 14-day post-exposure observation period.
Clinical signs:
other: There were no significant clinical observations noted immediately following exposure or at the 1-2 hour post-exposure. During the 14-day post-exposure period, dried red material on the dorsal neck was observed for 2 females and swollen facial area was obs
Body weight:
Four males and 2 females lost weight from study 0 to 1. All animals surpassed their initial (study day 0) body weight by study day 14 and were considered normal.
Gross pathology:
At scheduled necropsy, the only macroscopic finding noted was clear fluid contents in the uterus for 1 female. There were no other macroscopic findings for animals at the scheduled necropsy.

Any other information on results incl. tables

Nominal concentration data:

Group: 5.6 mg/L

Test substance used: 39.7 g

Generation time: 242 minutes

Nominal concentration: 5.2 mg/L

Actual exposure concentrations:

Group: 5.6 mg/L

Target concentration: 5 mg/L

Mean concentration: 5.6 mg/L

Standard deviation 0.53

N: 8

Aerosol particle size measurements:

Group: 2 mg/L

Mean MMAD (microns): 2.4

Mean GSD: 1.92

N: 2

Applicant's summary and conclusion

Interpretation of results:
not classified
Migrated information Criteria used for interpretation of results: EU
Based on the results of this study, the LC50 of JEFFSOL glycerine carbonate was > 5.6 mg/L when male and female Crl:CD(SD) albino rats were exposed to an aerosol of the substance as a single, 4-hour, nose-only exposure.