1-butoxypropan-2-ol

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

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 402 (Acute Dermal Toxicity)

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

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: ca. 8 weeks
- Weight at study initiation: ca. 217 g (females) and 327 g (males)
- Fasting period before study: none
- Housing: individually housed in 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 (%): 30-70%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

other: Test material was tested undiluted.

Details on dermal exposure:

TEST SITE
- Area of exposure: upper dorso-lateral area
- % coverage: 10
- Type of wrap if used: surgical gauze fixed to aluminium foil

REMOVAL OF TEST SUBSTANCE
- Washing (if done): After removal of the semi-occlusive bandage the remaining test substance was on the treated surface was gently removed with tissues moistened with tap-water.
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): dose volume was calculated based on the specific gravity of 0.88 g/ml
- Concentration (if solution): undiluted
- Constant volume or concentration used: constant concentration

VEHICLE
no vehicle used

Duration of exposure:

24 hours

Doses:

2000 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: 14 days
- Frequency of observations and weighing: On the day of treatment (day 0), animals were observed for toxicity and morbidity approximately every two hours.  Subjects were checked once daily thereafter except for weekends and holidays.  Individual body weights were recorded on test days 0, 7, and 14.  The treated areas of skin were examined on test days 4, 7, and 14 for signs of irritation.
- 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 deaths

Clinical signs:

other: No signs of systemic toxicity were observed during exposure and the following 14-day observation period. The treated skin surface of the animals showed no abnormalities.

Gross pathology:

Macroscopic examination of all animals at the end of the study revealed no test substance related gross abnormalities.

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:

The acute dermal LD50 for PnB is >2000 mg/kg bodyweight: no EU classification for acute dermal toxicity.

Executive summary:

A group of 5 male and 5 female Wistar rats was treated with a single application of 2,000 mg/kg propylene glycol n-butyl ether applied topically to the clipped, intact skin under
occlusion for a period of 24 hours.  Subjects were observed for clinical signs of toxicity and mortality during the
application period and for a period of 14 days after removal of the test material.  The skin of the rats at the site of
application was also evaluated for signs of irritation over the course of the study.  The undiluted test material was
applied at a single dose of 2,000 mg/kg to approximately 10% of the total body surface area of skin (clipped,
non-abraded) of the rats.  The test material was applied to gauze patches, which were then affixed to the clipped area
of the skin and covered with foil and wrapped with a bandage around the torso.  The test material was held in contact
with the skin for a period of 24 hours whereupon it was removed and the treated area was washed with water to remove remaining test material.  On the day of treatment (day 0), animals were observed for toxicity and morbidity
approximately every two hours.  Subjects were checked once daily thereafter except for weekends and holidays. 
Individual body weights were recorded on test days 0, 7, and 14.  The treated areas of skin were examined on test days 4, 7, and 14 for signs of irritation. Animals were sacrificed on day 14 and subjected to gross necropsy.

No deaths, clinical signs of toxicity, or skin irritation occurred over the course of the study.  The dermal LD50 for
propylene glycol n-butyl ether is greater than 2,000 mg/kg for male and female Wistar rats.