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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:
March-July 1987
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study according to OECD guideline 402
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

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
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Identity: Dowanol-DPnB (n-butoxypropoxypropanol or
dipropylene glycol normal-butyl ether).
CAS # 29911-28-2
Batch No.: XZ 95411.00
Purity: More than 95%
Appearance: Clear liquid.
Administered as: Undiluted liquid.
Vapor pressure: Not reported.
Specific Gravity: 0.91 g/ml.
Solubility: 5% in water.
Stability: Stable up to 200°C.

Dipropylene glycol n-butyl ether (DPnB) is a mixture of 4
possible isomers with the major isomers being
1-(1-n-butoxy-2-propoxy)-2-propanol and
2-(1-n-butoxy-2-propoxy)-1-propanol.

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River GmbH
- Age at study initiation: about 8 weeks
- Weight at study initiation: Males: 308-356 g, Females: 211-225 g
- Fasting period before study: none
- Housing: individually housed 7 days prior to testing
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum):ad libitum
- Acclimation period: 7 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-21
- Humidity (%): 30-70
- Air changes (per hr): n/a
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: To: n/a

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
A group of 5 male and 5 female Wistar rats (~7 weeks old) was treated with a single dose of 2,000 mg/kg dipropylene glycol n-butyl ether applied topically to the intact skin under occlusion for a period of 24 hours. 
Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
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 pure 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 frequently for toxicity and morbidity.  Thereafter, subjects were checked once daily 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.
Statistics:
none

Results and discussion

Preliminary study:
n/a
Effect levels
Sex:
male/female
Dose descriptor:
LD0
Effect level:
> 2 000 mg/kg bw
Mortality:
No deaths occurred over the course of the study. 
Clinical signs:
No clinical signs of toxicity or skin irritation occurred over the course of the study. 
Body weight:
n/a
Gross pathology:
No test material related gross abnormalties were identified.
Other findings:
none

Any other information on results incl. tables

The dermal LD50 for dipropylene glycol n-butyl ether is greater than 2,000 mg/kg for male and female Wistar rats.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
The substance is not classified for acute dermal toxicity according to EU criteria as the LD50 is greater than 2 000 mg/kg bw.
Executive summary:

A group of 5 male and 5 female Wistar rats (~7 weeks old) was treated with a single dose of 2,000 mg/kg dipropylene glycol n-butyl ether applied topically to the 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 pure 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 frequently for toxicity and morbidity.  Thereafter, subjects were checked once daily
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 dipropylene glycol n-butyl ether is greater than 2,000 mg/kg for male and female Wistar rats.