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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

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Diss Factsheets

Toxicological information

Acute Toxicity: inhalation

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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: Comparable to guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report date:
1988

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Deviations:
yes
Remarks:
not specified
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Reference substance name:
PMDETA
IUPAC Name:
PMDETA
Test material form:
other: vapour
Details on test material:
PMDETA (Lot# 6872641)
Obtained from: BASF Corporation, Chemicals Division
Purity confirmed by GC-MS and infrared spectroscopy: 99.1%
Physical State: Liquid
Boiling Point: 203.5"C @ 760 mm Hg
Vapor Pressure: 0.422 mm Hg @ 2S°C
Dow Registry: 0034-8505

Test animals

Species:
rat
Strain:
Fischer 344
Sex:
male/female
Details on test animals or test system and environmental conditions:
Animals obtained from: Charles River Breeding Laboratories, Inc., Kingston, NY
Age of animals: 6 weeks
Animal housing: 2 per cage
Acclimation: 1 week prior to exposure
Assignment to exposure group: done by computer randomisation program
Water and Purina Certified Rodent Chow (Ralston Purina Co., St. Louis, MO) were available ad libitum except during exposure.

Administration / exposure

Route of administration:
inhalation: vapour
Type of inhalation exposure:
whole body
Vehicle:
air
Details on inhalation exposure:
Vapors of PMDETA were generated using a glass J-tube method described by Miller, et al., (1980).
Chamber air flow, temperature and relative humidity were recorded at approximately half hour intervals during the 6 hour exposure period.
Sampling for analytical verification of test atmosphere concentrations was conducted near the breathing zone of the animals.
Analytical verification of test atmosphere concentrations:
yes
Remarks:
gas chromatography (Varian 1400, Palo Alto, CA) using a flame ionization detector
Duration of exposure:
6 h
Concentrations:
69, 164, 230 or 366 ppm; corresponding nominal concentrations 54, 152, 195 and 380 ppm
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
Duration of observation period following exposure: 14 days
Frequency of observations: daily during exposure and observation
Frequency of weighing: days 2, 4, 8, 11 and 15.
Necropsy of survivors performed: yes
Other examinations performed: clinical signs - changes in fur, eyes, mucous membranes and respiration; behavior pattern and nervous system
activityassessed by specific observation for tremors, convulsions, salivation, lacrimation, and diarrhea, as well as lethargy and other signs of
altered central nervous system function; body weight measurements
Statistics:
Means and standard deviations of animal body weight, chamber temperature, relative humidity, and air flow were calculated for descriptive
purposes.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LC50
Effect level:
290 ppm
Based on:
test mat.
Exp. duration:
6 h
Remarks on result:
other: 290 ppm = 2055.5 mg/m3
Mortality:
Rats exposed to 366 ppm PMDETA died immediately following exposure or were found dead on test day 2.
All rats exposed to 69, 164 and 230 ppm PMDETA survived the two-week post-exposure period.
Clinical signs:
other: Concentration dependent in-life observations of eye squint, corneal cloudiness, labored breathing and porphyrin staining of the external nares and eyes indicative of eye and nasal irritation. No skin irritation observed.
Body weight:
Mean body weights were decreased from pre-exposure values in all three groups during the first week post-exposure. By the end of the post- exposure period mean body weights were approximately equal to or greater than pre-exposure weights.
Gross pathology:
Residual evidence of eye irritation was the only treatment-related change identified upon gross pathologic examination.

Applicant's summary and conclusion