Butane-1,4-diol

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Acceptable, well-documented publication which meets basic scientific principles

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1981

Report date:

1981

Materials and methods

Principles of method if other than guideline:

BASF-internal standard: Estimation of the acute hazard potential via dermal route (determination of the acute dermal LD50 value).

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Butane-1,4-diol

EC Number:

203-786-5

EC Name:

Butane-1,4-diol

Cas Number:

110-63-4

Molecular formula:

C4H10O2

IUPAC Name:

butane-1,4-diol

Details on test material:

- Name of test material (as cited in study report): 1.4-Butanediol
- Physical state: colorless liquid
- Analytical purity: 99.3 %
- Impurities (identity and concentrations): 2-Methylbutandiol 1,4: 0.4%; Methylpentandiol: 0.2%

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River, Sulzfeld/Germany
- Age at study initiation: 12 weeks
- Weight at study initiation: male: 219 g (mean); female: 196 g (mean)
- Housing: 5 animals per cage in V-II-A stainless steel wire mesh cages (supplied by Becker and Co., Castrop-Rauxel/Germany)
- Diet: SSNIFF R, Ssniff Versuchstierdiaeten, Soest/Germany
- Water: Fully demineralized water each workday, ad libitum; tap water on public holidays, ad libitum.
- Acclimation period: Acclimatization in the animal care unit for at least one week


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 26 °C
- Humidity (%): 45 - 75 %
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:

occlusive

Vehicle:

water

Details on dermal exposure:

TEST SITE
- Area of exposure: 50 cm2
- Type of wrap if used: inert foil


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

Duration of exposure:

24 h

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: <15 min, 15 min, 30 min, 1 h, 2 h, 4 h and 5 h after administration of test substance and then once each workday. Check for moribund and dead animals twice each workday and once daily at weekends and on public holidays.
- Frequency of weighing: days 0, 3, 7, 13
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

No mortalities occurred.

Clinical signs:

other: Systemic toxicity: dyspnoea, unsettled behaviour and poor general state within the first 2 h of exposure. Local toxicity: very slight erythema on day 1 after removal of the test substance.

Gross pathology:

No abnormalities observed.

Any other information on results incl. tables

Mean Weight (g):

Dose (mg/kg bw)	day 0		day 3		day 7		day 13
	male	female	male	female	male	female	male	female
2000	219	196	228	199	264	216	314	232

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU