1-butoxypropan-2-ol

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1987

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP-study according to OECD guideline

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1987

Report date:

1987

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

1-butoxypropan-2-ol

EC Number:

225-878-4

EC Name:

1-butoxypropan-2-ol

Cas Number:

5131-66-8

Molecular formula:

C7H16O2

IUPAC Name:

1-butoxypropan-2-ol

Details on test material:

Identity: Dowanol-PnB (1-butoxy-2-hydroxypropane or
propylene glycol normal-butyl ether). CAS # 29387-86-8
(also 5131-66-8)

Batch No.: XZ 95410.00
Purity: "More than 98%"
Supplied as: Not reported.
Appearance: Clear liquid.
Administered as: Undiluted liquid.
Specific Gravity: 0.88 g/ml.
Solubility: 6% in water.
Stability: Stable up to 200°C.

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Wiga GmbH
- Age at study initiation: 8-9 weeks
- Weight at study initiation: 343 to 416 g (males) & 207 to 269 g (females)
- Fasting period before study: Animals were fasted overnight prior to dosing and were not allowed food until 5.5 hr after dosing.
- Housing: polycarbonate cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-21°C
- Humidity (%): 50-70%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: no vehicle; test material was tested indiluted

Details on oral exposure:

substance dosed undiluted via oral gavage

Doses:

1800, 2400, 3200 mg/kg body weight

No. of animals per sex per dose:

5

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: Subjects were observed for mortality and signs of toxicity several times on the day of dosing (Day 0) and on weekdays thereafter for up to 14 additional days.
- Frequency of observations and weighing: Body weights were recorded immediately prior to dosing, weekly thereafter, and at death.
- Necropsy of survivors performed: Non-survivors were necropsied as soon as possible and surviving animals were subjected to necropsy on day 14.
- Other examinations performed: clinical signs, body weight

Results and discussion

Preliminary study:

To establish an appropriate dose range four groups of animals, each comprising 1 male and 1 female, were dosed with an oral dose of the test substance at 1000, 1800, 3200 and 5600 mg/kg body weight, respectively. Mortalities occurred in the 3200 and 5600 mg/kg dose group (both animals). Major signs of toxicity were lethargy, hyperpnoea and dacryorrhoea. The observation period was 7 days.

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LD50

Effect level:

3 300 mg/kg bw

Based on:

test mat.

95% CL:

2 800 - 4 500

Effect levels 2

Sex:

male

Dose descriptor:

LD50

Effect level:

5 500 mg/kg bw

Based on:

test mat.

Remarks on result:

other: no confidence limits

Effect levels 3

Sex:

female

Dose descriptor:

LD50

Effect level:

2 700 mg/kg bw

Based on:

test mat.

95% CL:

2 400 - 3 600

Mortality:

1800 mg/kg: 0/10
2400 mg/kg: 1/10
3200 mg/kg: 5/10

Clinical signs:

other: Signs of toxicity were lethargy, comatose, hypopnoea, gasping respiration amd rough coat. For surviving animals these signs were reversible within 2 days.

Gross pathology:

Maroscopic examination of animals at necropsy revealed haemorrhage of the stomach, bloody or yellow content of the small intestines, haemorrhage of the small intestines, bloody content of the bladder, hyperaemia of the bladder.

Other findings:

none

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Oral LD50 of 3300 mg/kg: no EU classification for acute oral toxicity.

Executive summary:

Three groups of Wistar rats (5/sex/dose level) received
single oral doses of 1800, 2400, or 3200 mg/kg propylene
glycol n-butyl ether (PnB), administered undiluted using a
stainless steel stomach cannula attached to a syringe. 

No rats died from a dose of 1800 mg/kg PnB.  One female died
after a dose of 2400 mg/kg.  Four females and one male died
at 3200 mg/kg.  The calculated oral LD50 for males alone was
5500 mg/kg (no 95% confidence limits), for females alone was
2700 mg/kg (95% CL: 2400 - 3600 mg/kg), and for both sexes
combined was 3300 (95% CL: 2800 - 4500 mg/kg).

All deaths occurred within one day of dosing.  Adverse signs
included weight loss, lethargy, coma, hypopnea, gasping, and
dacryorrhea.  Surviving rats showed no adverse signs by day
2.  At necropsy, surviving rats showed no grossly observable
lesions.  Rats dying from treatment exhibited hemorrhage of
the stomach and small intestine, bloody content of the small
intestine and bladder, yellow liquid within the small
intestine, and hyperemia of the bladder.