2-Butene, 1,1,4,4-tetramethoxy-

Acute Toxicity: oral

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-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

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

Test material information

Constituent 1

Reference substance name:

(2E)-1,1,4,4-tetramethoxybut-2-ene; (2Z)-1,1,4,4-tetramethoxybut-2-ene

EC Number:

900-110-7

Cas Number:

5370-08-1

Molecular formula:

C8H16O4

IUPAC Name:

(2E)-1,1,4,4-tetramethoxybut-2-ene; (2Z)-1,1,4,4-tetramethoxybut-2-ene

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 levels

Effect levels 1

Sex:

female

Dose descriptor:

LD50

Effect level:

>= 200 - <= 400 mg/kg bw

Based on:

test mat.

Effect levels 2

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.