Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1.11. - 15.11.1990
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: old guidelines followed, no GLP documentation available
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report date:
1991

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
3 instead of 5 males/females / dose group
GLP compliance:
yes
Remarks:
statement of compliance
Test type:
acute toxic class method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Reaction mass of [trans-1,1,4,4-Tetramethoxy-2-butene + cis-1,1,4,4-Tetramethoxy-2-butene]
EC Number:
900-110-7
Cas Number:
5370-08-1
Molecular formula:
C8H16O4
IUPAC Name:
Reaction mass of [trans-1,1,4,4-Tetramethoxy-2-butene + cis-1,1,4,4-Tetramethoxy-2-butene]
Details on test material:
- Name of test material (as cited in study report): C4-diacetal
- Physical state:
- Analytical purity: 97.1%
- Storage condition of test material: at room temperature; protected from humidity

Test animals

Species:
rat
Strain:
other: Fü-Albino outbred stock Ibm:RORO (SPF)
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
arachis oil
Doses:
200, 400, 800 mg/kg bw
No. of animals per sex per dose:
Dose groups: 3
Control group: 5
Control animals:
yes

Results and discussion

Effect levelsopen allclose all
Sex:
female
Dose descriptor:
LD50
Effect level:
>= 200 - <= 400 mg/kg bw
Based on:
test mat.
Sex:
male
Dose descriptor:
LD50
Effect level:
>= 400 - <= 800 mg/kg bw
Based on:
test mat.

Any other information on results incl. tables

Table 1

Mortalities 14 days after single dosing

--------------------------------------------

Dose level

mg / kg ........ Males ....... Females

0                     0/5                     0/5

200                   0/3                     1/3

400                   1/3                     2/3

800                   2/3                     3/3

--------------------------------------------

Applicant's summary and conclusion

Interpretation of results:
moderately toxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
LD50 p.0. in the female rat between 200 and 400 mg/kg body weight. The toxicity in the male rat seems to somewhat
lower and the approx. LD50 has to be situated between 400 and 800 mg/kg body weight.
Executive summary:

Assessed with this method Ro 94-0101/000 is moderately toxic,

having an approx. LD50 p.0. in the female rat between 200 and 400

mg/kg body weight. The toxicity in the male rat seems to somewhat

lower and the approx. LD50 has to be situated between 400 and 800

mg/kg body weight. Clinical signs observed during the first four

hours after treatment were trace to marked sedation, and increased

salivation and heavy breathing at the highest dose level. Where

deaths occurred, the animals died overnight.

All surviving animals regained control behaviour within 24h and

showed it during the rest of the 14-day observation period. No

signs of gross pathological changes were found by necropsy at the

end of the observation period, with the exeption of one male in

the highest dose group (no. 13), where a part of the stomach was

grown together with the diaphragm.

Categories Display