Reaction mass of 1,2-Diacetoxy-3-butene and 1,2-Dihydroxy-3-butene, monoacetate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study conducted under GLP conditions.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1996

Report date:

1996

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

yes (incl. QA statement)

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

3-Butene-1,2-diol, diacetate

IUPAC Name:

3-Butene-1,2-diol, diacetate

Constituent 2

Reference substance name:

1,2-diacetoxybut-3-ene

EC Number:

421-720-5

EC Name:

1,2-diacetoxybut-3-ene

Cas Number:

18085-02-4

Molecular formula:

C8 H12 O4

IUPAC Name:

1,2-diacetoxybut-3-ene

Details on test material:

- Name of test material (as cited in study report): 3,4-DIACETOXY-1-BUTENE, SYNONYM: DIACETOXYBUTENE

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Crl:CD(SD)BR VAF plus; Charles River Kingston (Stone Ridge, NY)
- Age at study initiation: male rats were 6-7 weeks of age; female rats were 7-8 weeks of age
- Weight at study initiation: male rats weighed 162 to 191 grams; female rats weighed 161 to 170 grams
- Fasting period before study: overnight before single dose gavage
- Housing: rats were singly housed in suspended, stainless-steel, wire mesh cages. Cages and racks were washed once a week. Absorbent paper, used to collect excreta, was changed at least three times a week.
- Diet (e.g. ad libitum): Certified Rodent Diet (Purina Rodent Chow #5002, pellets) was available ad libitum
- Water (e.g. ad libitum): Water was available ad libitum through an automatic watering system
- Acclimation period: 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 54-60
- Air changes (per hr): no details
- Photoperiod (hrs dark / hrs light): photoperiod of 12 hours light from 6 a.m. to 6 p.m.

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Type of wrap if used: A single dose of the test substance was placed in contact with the skin using a fiber pad and an occlusive wrap to hold the test material in place for 24 hours.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): running water
- Time after start of exposure: 24h

TEST MATERIAL
- Constant volume or concentration used: yes

Duration of exposure:

24h

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: days 0, 7, 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Statistics:

No statistical procedures were required during the study. No dose/mortality curve was
constructed since graphs become statistically useful only with the use of large numbers of
animals and dose groups .

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Remarks on result:

other: limit test - single dose did not cause mortalities

Mortality:

No mortalities occured.

Clinical signs:

other: No abnormal clinical signs were observed.

Gross pathology:

No treatment-related changes were observed at necropsy, an d no tissue was collected for microscopic examination.