Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: non guideline study, no GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report Date:
1978

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Principles of method if other than guideline:
Method: other: BASF-Test
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
IUCLID4 Test substance: as prescribed by 1.1 - 1.4

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
CMC (carboxymethyl cellulose)
Remarks:
0.5% aqueous carboxymethyl cellulose preparation v/v
Doses:
4640, 6810, and 10000
No. of animals per sex per dose:
5
Control animals:
no

Results and discussion

Effect levels
Dose descriptor:
LD50
Effect level:
ca. 4 600 mg/kg bw
Clinical signs:
Staggering; signs of paresis; narcotic-like state with absence of pain reflex and corneal reflex
Other findings:
Animals that died:
heart: acute dilatation; acute passive hyperemia;
stomach: malacia of the mucosa
intestines: atonic and diarrheal contents
liver: peripheral clay-colored acinar pattern (degeneration) in some cases
thorax: hydrothorax sporadically

Sacrificed animals:
Stomach: adhesions of the stomach to the peritoneum; mucosa of the forestomach thickened

Applicant's summary and conclusion

Conclusions:
Based on the available data, the acute oral LD50 was determined to be 4600 mg/kg bw.
Executive summary:

After a single oral dose administered to rats the calculated LD50 value of 3,4-dihydropyran was 4600 mg/kg bw.