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Diss Factsheets

Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2009-04-16 to 2009-07-24
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
2009
Report date:
2009
Reference Type:
other: position paper
Title:
Unnamed
Year:
2012
Report date:
2012

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.1300 (Acute inhalation toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
traditional method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
(3E)-dec-3-en-2-one
Cas Number:
18402-84-1
Molecular formula:
C10H18O
IUPAC Name:
(3E)-dec-3-en-2-one
Details on test material:
- CAS: 18402-84-1
- Purity: 98.57% to 99.11% w/w
- Batch No.: Lot KB 147-36-1
- Physical state: liquid
- Colour: Colorless to pale yellow
- Storage conditions: room temperature

Test animals

Species:
rat
Strain:
not specified
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Received from Ace Animals, Inc., Boyertown, PA on March 31 and April 28, 2009.
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 9-11 weeks
- Weight at study initiation: 267 - 346 g (males) and 210 - 248 (females)
- Housing: The animals were singly housed in suspended stainless steel caging with mesh floors which conform to the size recommendations in the most recent Guide for the Care and Use of Laboratory Animals DHEW (NIH). Litter paper was placed beneath the cage and was changed at least three times per week.
- Diet (e.g. ad libitum): Purina Rodent Chow #5012
- Water (e.g. ad libitum): Tap water was supplied ad-libitum by an automatic water dispensing system except during exposure.
- Acclimation period: 13 - 20 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-23
- Humidity (%): 50-67
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Route of administration:
inhalation
Type of inhalation exposure:
nose only
Vehicle:
air
Mass median aerodynamic diameter (MMAD):
>= 2.6 - <= 3 µm
Geometric standard deviation (GSD):
>= 1.85 - <= 1.87
Remark on MMAD/GSD:
An eight-stage Andersen cascade impactor was used to assess the particle size distribution of the test atmosphere. Samples were withdrawn
from the breathing zone of the animals at two intervals during each exposure. The filter paper collection stages were weighed before and after sampling to determine the mass collected upon each stage. The aerodynamic mass median diameter and geometric standard deviation were determined graphically using two-cycle logarithmic probit axes.
Details on inhalation exposure:
The exposure chamber, air supply and equipment used to measure particle size distribution, airflow and chamber concentration were the same as used during the pre-test trials and are described below.
- Nose-Only Exposure Chamber: A nose-only inhalation chamber with an internal volume of approximately 6.7 liters (Mini-Nose Only Inhalation Chamber, ADG Developments LTD) was used for exposure. Animals were individually housed in polycarbonate holding tubes which seal to the chamber with an "0" ring during exposure. The base unit terminates the chamber with a 0.5-inch diameter tube for discharged air.
- Air Supply: Filtered air was supplied by an air compressor (JUN-AIR, Model #6-15) to the spray atomization nozzle. Additional compressed mixing air, supplied from a compressed air tank (Airgas), was introduced into the chamber to help uniformly distribute the test atmosphere by creating a vortex at the chamber inlet. Compressed airflow was measured with a Mass Flowmeter (Omega, Model #FMA-5613). Chamber airflow was monitored throughout the exposure period and recorded periodically.
- Ambient Conditions: The temperature and relative humidity within the chamber as well as the room were monitored continuously during each exposure. In-chamber measurements were made with a Humidity-Temperature Indicator (Taylor, Model #5502) and room conditions were measured with a Temperature-Humidity Monitor (Dickson, Model #TH550). Temperature and humidity values were recorded every 15 minutes for the first hour of exposure and every 30 minutes thereafter.
- Atmosphere Generation: The test atmosphere was generated using a1/4 inch JCO atomizer (Spraying Systems Co.), FC3 fluid cap (Robert Miller Associates) and 70SS air cap (Spraying Systems Co.). The test substance was metered to the atomization nozzle through size 13 or 14 Viton tubing, using a peristaltic pump (Master Flex, Model #7520-35).
- Chamber Concentration Measurements: Gravimetric samples were withdrawn at 6 intervals from the breathing zone of the animals during each exposure. Samples were collected using 25 mm glass fiber filters (GF/B Whatman) in a filter holder attached by 1/4, inch tygon tubing to a vacuum pump (Reliance Electric, Model #G557X). Filter papers were weighed before and after collection to determine the mass collected. This value was divided by the total volume of air sampled to determine the chamber concentration. Sample airflows were measured using a Flowmeter (Omega, Model #FMA-5610).
- Exposure Period: For each exposure level, the animals were exposed to the targeted chamber concentration for at least 4 hours. At each level, the exposure period was extended beyond 4 hours to allow the chamber to reach equilibrium (T99). At the end of each exposure period, the generation was tenninated and the chamber was operated for a further 15 minutes with clean air. At the end of this period the animals were removed from the exposure tube. Prior to being returned to their cages, excess test substance was removed from the fur of each animal.
Analytical verification of test atmosphere concentrations:
yes
Duration of exposure:
>= 4 h
Remarks on duration:
At each level, the exposure period was extended beyond 4 hours to allow the chamber to reach equilibrium (T99). At the end of each exposure period, the generation was terminated and the chamber was operated for a further 15 minutes with clean air.
Concentrations:
0.52, 2.04 mg/L
No. of animals per sex per dose:
5 Males and 5 Females (2.04 mg/L)
5 Males (0.52 mg/L)
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: All animals were observed for mortality during each exposure period. All animals were observed for mortality during each exposure period. The animals were examined for signs of gross toxicity, and behavioral changes upon removal from the exposure chamber and at least once daily thereafter for up to 14 days or until death occurred. Observations included gross evaluation of skin and fur, eyes and mucous membranes, respiratory, circulatory, autonomic
and central nervous systems, somatomotor activity and behavior pattern. Particular attention was directed to observation of tremors, convulsions, salivation, diarrhea, and coma. Individual body weights of the animals were recorded prior to test substance exposure (initial) and again on Days 7 and 14 (termination) or after death.
- Necropsy of survivors performed: Surviving rats were euthanized via C02 inhalation on Day 14. Gross necropsies were performed on all decedents and euthanized animals. Tissues and organs of the thoracic and abdominal cavities were examined.

Results and discussion

Effect levelsopen allclose all
Key result
Sex:
male
Dose descriptor:
LC50
Effect level:
> 0.52 - < 2.04 mg/L air
Based on:
test mat.
Exp. duration:
4 h
Key result
Sex:
female
Dose descriptor:
LC50
Effect level:
> 2.04 mg/L air
Based on:
test mat.
Exp. duration:
4 h
Mortality:
At the 0.52 mg/L dose level one animal (male) died within one day of exposure to the test atmosphere. Prior to death, this animal was hypoactive and exhibited irregular respiration and moist rales.
At 2.04 mg/L one male died following exposure to the test atmosphere. There were no clinical signs observed for this animal prior to death. Two males died within two days of exposure to the test atmosphere. Prior to death these animals were hypoactive and exhibited abnormal respiration, nasal discharge, facial staining, hunched posture, reduced fecal volume and were cold to touch.
Clinical signs:
other: 0.52 mg/L exposure level: Clinical signs exhibited for the surviving animals included irregular respiration, rales, hunched posture, hypoactivity, reduced fecal volume, facial and/or ano-genital staining. However, these animals recovered by Day 7 gaining
Body weight:
At 0.52 mg/L survival animals gained weight.
At 2.04 mg/L three animals lost weight by Day 7, all animals gained body weight over the 14-day observation period.
Gross pathology:
At 0.52 mg/L gross necropsy of the decedent revealed extremely red lungs. No gross abnormalities were noted for any of the necropsied animals at the conclusion of the 14-day observation period.
At 2.04 mg/L gross necropsy of the decedent revealed edema and discoloration of the lungs, discoloration of the liver, gas distended yellow intestines and/or rigor mortis. No gross abnormalities were noted for the euthanized animals when necropsied at the conclusion of the 14-day observation period.

Any other information on results incl. tables

Table 1: Mortality data

Dose (mg/L)

Males

Females

Combined

0.52

1/5

-*

1/5

2.04

3/5

0/5

3/5

* Based on the results of the 2.04 mg!L exposure level, only five males were tested at the 0.5 mg/L level.

Table 2: Clinical observations

Observation

0.52 mg/L

2.04 mg/L

Males*

Males*

Females

Rales

4/4

2/2

3/5

Irregular respiration

4/4

2/2

5/5

Hypoactivity

3/4

2/2

5/5

Reduced faecal volume

2/4

2/2

5/5

Ano-genital staining

2/4

0/2

0/5

Facial staining

2/4

2/2

4/5

Oral/nasal discharge (red)

0/4

0/2

3/5

* Data from surviving animals only are recorded, since intercurrent deaths occurred within 2 hours of the end of exposure.

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
Based on the results from an acute inhalation toxicity test conducted in accordance with OECD test guideline 403, it can be concluded that the acute inhalation LC50 is between 0.52 mg/L and 2.04 mg/L in male rats and is greater than 2.04 mg/L in female rats. According to CLP Regulation 1272/2008 classification as Acute Tox. 4, H332 is warranted.
Executive summary:

In an acute inhalation toxicity study (OECD 403, GLP) groups of young adult male and female rats were exposed by inhalation route to (3E)-dec-3-en-2-one for 4 hours nose only at concentrations of 0.52 and 2.04 mg/L. Animals were observed for 14 days. At the 0.52 mg/L exposure level five males were exposed. One animal died and clinical signs exhibited for the surviving animals included irregular respiration, rales, hunched posture, hypoactivity, reduced fecal volume, facial and/or ano-genital staining. However, these animals recovered by Day 7 gaining body weight and appearing active and healthy for the remainder of the 14-day observation period. Gross necropsy of the decedent revealed extremely red lungs. No gross abnormalities were noted for any of the necropsied animals at the conclusion of the 14-day observation period.

At the 2.04 mg/L exposure level five males and five females were exposed. One male died following exposure to the test atmosphere. Two males died within two days of exposure to the test atmosphere. Following exposure, clinical signs for the surviving animals included hypoactivity, hunched posture, abnormal respiration, reduced fecal volume, nasal and oral discharge and/or facial staining. However, these animals recovered by Day 10 and appeared active and healthy for the remainder of the study. Although three animals lost weight by Day 7, all animals gained body weight over the 14-day observation period. Gross necropsy of the decedent revealed edema and discoloration of the lungs, discoloration of the liver, gas distended yellow intestines and/or rigor mortis. No gross abnormalities were noted for the euthanized animals when necropsied at the conclusion of the 14-day observation period.

Under the conditions of this study, the acute·inhalation LC50 of the test substance is between 0.52 mg/L and 2.04 mg/L in male rats and is greater than 2.04 mg/L in female rats.