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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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
Study period:
1981
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Well performed and reported study similar to current OECD guideline.

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)
Deviations:
no
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
But-3-en-3-olide
EC Number:
211-617-1
EC Name:
But-3-en-3-olide
Cas Number:
674-82-8
Molecular formula:
C4H4O2
IUPAC Name:
4-methylideneoxetan-2-one
Constituent 2
Reference substance name:
Diketene
IUPAC Name:
Diketene
Details on test material:
no data

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
Origine: IFFA CREDO, Apres une periode d`adaption d`une semaine a l`animalerie, les animeaux sont stabules par groupe de 5.
soit dans les cages en Makrolon comportant une litiere de sciure de bois sterilisee et depoussieree, en dehors des periodes d`inhalation
soit dans les cages grillagees en acier inoxydable situees dans un meme plan pendant les seances d`inhalation
Aliment: Souriffarat (en dehors de la periode d`inhalation)
Abreuvement: Eau ad libitum (en dehors de la periode d`inhalation)
Environment (Animalerie): Renouvellement d`air: 8 par heure, Temperature: 22 +- 1,5 °C, Hygrometrie: 55 % +- 15 %, Eclairment: 12/24 ( par minuterie)

Administration / exposure

Route of administration:
inhalation: aerosol
Type of inhalation exposure:
whole body
Vehicle:
air
Details on inhalation exposure:
Les animeaux sont exposes au produit aerosolise a une concentration connue dans l`air et pendant un temps determine. On utilise la technologie avec un perfuser pour doser le diketene, un debimetre a flotteur pour determine la quantite d`air correspondant et un seche-cheveaux pour evaporer diketene condense.
Analytical verification of test atmosphere concentrations:
not specified
Duration of exposure:
4 h
Concentrations:
0.452 g/ccm, 0.677 g/ccm, 0.787 g(ccm, 0.847 g/ccm, 1.142 g/ccm, 1,700 g/ccm
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
14 d observation period

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LC50
Effect level:
940 mg/m³ air
Based on:
test mat.
Exp. duration:
4 h
Sex:
female
Dose descriptor:
LC50
Effect level:
1 008 mg/m³ air
Based on:
test mat.
Exp. duration:
4 h
Sex:
male
Dose descriptor:
LC50
Effect level:
820 mg/m³ air
Based on:
test mat.
Exp. duration:
4 h
Mortality:
at 0.452 g/ccm, 0.677 g/ccm, 0.787 g(ccm, 0.847 g/ccm, 1.142 g/ccm, 1,700 g/ccm: 0 %, 0 %, 40 %, 60 %, 100 %, 100 % male dead after 14 d and 0 %, 0 %, 20 %, 0 %, 60 %, 100 % female dead after 14 d
Clinical signs:
other: Detresse respiratoire, Fermeture de la fente palpebrale, Dyspnee - larmoiements - rhinorrhee et leger epistaxis
Body weight:
150 - 200g
Gross pathology:
Il apparait qu`un oedeme aigu hemorragique du poumon soit responsable de la mort des animeaux. La frquence de cette alteration est fonction de la dose administree. Li s`y associe une congestion hepatique, ceci est classique dans l`oedeme aigu pulmonaire qui entaine une defaillance du coeur droit.

Applicant's summary and conclusion

Interpretation of results:
Toxicity Category II
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The LC50 (4h) of Diketene for rats was derived at 940 ppm corresponding to 0.94 mg/L , for male rats at 820 ppm corresponding to 0.82 mg/L and for female rats at 1008 mg/L corresponding to 1.01 mg/L
Executive summary:

The LC50 of Diketene was determined in an acute inhalation study. Groups of male and female rats were exposed to atmospheres of 0.452 g/ccm, 0.677 g/ccm, 0.787 g(ccm, 0.847 g/ccm, 1.142 g/ccm, 1,700 g/ccm for 4 hours. The LC50 (4h) of Diketene for rats was derived at 940 ppm corresponding to 0.94 mg/L , for male rats at 820 ppm corresponding to 0.82 mg/L and for female rats at 1008 mg/L corresponding to 1.01 mg/L