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Toxicological information

Acute Toxicity: dermal

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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:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes (incl. certificate)
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
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 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:
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.
Body weight:
Weekly group mean body weight gain was normal.
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.