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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to a BASF internal test method, which in principle was similar to the Inhalation Hazard Test as described in Annex V of the OECD TG 403 81981). GLP was not compulsory at the time the study was conducted.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report date:
1981

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Version / remarks:
(1981; Annex V: Inhalation Hazard Test)
Principles of method if other than guideline:
similar to H.F. Smyth et al. (1962) Am. Ind. Hyg. Ass. J. 23 (95-107)
GLP compliance:
no
Remarks:
GLP was not compulsory at the time the study was conducted
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
(R)-1-hydroxy-1-phenylacetone
EC Number:
217-285-4
EC Name:
(R)-1-hydroxy-1-phenylacetone
Cas Number:
1798-60-3
Molecular formula:
C9H10O2
IUPAC Name:
(1R)-1-hydroxy-1-phenylpropan-2-one
Details on test material:
- Name of test material: (-)-Phenylacetylcarbinol
- Physical state: liquid
- Analytical purity: 67.4 %

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Fa. Wiga Versuchstieranstalt, Sulzfeld, Germany
- Age at study initiation: 7 to 10 weeks
- Weight at study initiation: male 180 - 250 g, female 180 - 250 g
- Housing: 3 animals /cage, Becker D III cages
- Diet (e.g. ad libitum): Pellets, Herilan MRH (Eggersmann KG, Rinteln), ad libitum
- Water (e.g. ad libitum): ca. 250 mL/cage
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2°C
- Humidity (%): 55 ± 5 %
- Photoperiod (hrs dark / hrs light): 12 h/12 h

Administration / exposure

Route of administration:
inhalation: vapour
Type of inhalation exposure:
whole body
Vehicle:
air
Details on inhalation exposure:
The product was filled in a glass bottle to a height of 5 cm (fritted glass flask; pore size 90- 150 µm and diameter 30 mm) and the weight was determined.
A stream of 200 L/h compressed air was supplied to the fritted glass flask containing the product, which had been placed in a water bath maintained at 20±1°C by a thermostat.
The mixture of air and test substance generated in this way was passed through a glass distributor to 6 glass tubes in which 3 male and 3 female animals had been placed. The emerging mixtures of vapor and air were exhausted. After 30 minutes, the fritted glass flask was replaced by a new one filled with fresh test substance as described above. This receiver was then used for the whole remaining time of the test.

Analytical verification of test atmosphere concentrations:
no
Remarks:
(test item was determined gravimetrically, therefore at the end of the exposure period the glass flask was reweighted)
Duration of exposure:
7 h
Concentrations:
maximum concentration of 2 tests: 0.25 mg/L (related to 7 hrs exposure time)
No. of animals per sex per dose:
6 per test (in 2 independent tests)
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations for symptoms and mortality: daily
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 0.25 mg/L air
Based on:
test mat.
Exp. duration:
7 h
Remarks on result:
other: no mortality was seen
Mortality:
no mortality observed
Clinical signs:
other: wiping of the mouth
Body weight:
no data
Gross pathology:
no findings

Applicant's summary and conclusion