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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:
1988
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: This study was conducted under GLP and according to OECD guideline 402.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report date:
1987

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes
Test type:
fixed dose procedure
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
[(butoxymethylethoxy)methylethoxy]propan-1-ol
EC Number:
259-910-3
EC Name:
[(butoxymethylethoxy)methylethoxy]propan-1-ol
Cas Number:
55934-93-5
Molecular formula:
C13H28O4
IUPAC Name:
[(butoxymethylethoxy)methylethoxy]propan-1-ol
Details on test material:
- Name of test material (as cited in study report): Tripropylene glycol n-butyl ether
- Physical state: Colorless liquid
- Analytical purity: 99%
- Lot/batch No.: May 87
- Stability under test conditions: Estimated to be minimum 2 years under these conditions
- Storage condition of test material: At ambient temperature in the dark

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, Sulzfeld
- Age at study initiation: 9 weeks approximately
- Weight at study initiation: Males: 349 to 398 gms and Females: 241 to 254 gms
- Housing: Rats were individually housed in polycarbonate cages
- Diet (ad libitum): Rats were supplied by standard diet RMH-B, pellet diameter 10 mm from Hope Farms, Woerden, and The Netherlands
- Water (ad libitum): Tap water
- Acclimation period: 6 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19°C to 23°C
- Humidity (%): 65-95%
- Air changes (per hr):
- Photoperiod: 12hrs dark /12 hrs light


IN-LIFE DATES: From: 1987-10-02 to: 1987-10-16

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: Fur from upper-dorso-lateral area of each animal was clipped to expose Approximately 10% of the total body surface area
- % coverage: Approximately 10% of the total body surface area
- Type of wrap if used: Undiluted test substance was evenly spread on surgical gauze (5×5 cm and 5×3.5 cm for males and females respectively) that was fixed to aluminum foil with a drop of Vaseline. Again with a drop of Vaseline this patch was attached to flexible bandage which was applied to clipped area of trunk of each animal and fixed with adhesive tape.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): After 25 hours of exposure, the semi-occlusive bandage was removed and discarded and the remaining test substance on the treated surface was gently removed with tissues moistened with tap water.
- Time after start of exposure: 25 hours


Duration of exposure:
25 hours
Doses:
single dose of 2000 mg/kg bw
No. of animals per sex per dose:
5/sex
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: Cage-side observations were performed on the day of dosing (approximately once every 2 hours) and daily thereafter, with exception weekends and holidays a mortality check was performed at the end of the day.
- Frequency of weighing: Weekly
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levelsopen allclose all
Sex:
male
Dose descriptor:
LD0
Effect level:
> 2 000 mg/kg bw
Sex:
female
Dose descriptor:
LD0
Effect level:
> 2 000 mg/kg bw
Mortality:
No mortalities occurred during exposure and 14 day exposure period.
Clinical signs:
No signs of systemic toxicity were observed during exposure and 14 day observation period.
Body weight:
Weekly group mean body weight gain was normal.
Gross pathology:
Macroscopic examination at necropsy of all animals at the end of the study revealed no test substance related gross abnormalities.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
Based on the results of this the dermal LD0 of TPnB in male and female rats was > 2000 mg/kg.
Executive summary:

One group of Wistar rats comprising 5 males and 5 females was treated with a single dermal dose of TPnB (Tripropylene glycol n-butyl ether) colorless liquid at 2000 mg/kg body weight for 25 hours. Rats were received from Charles River Wiga GmbH, Sulzfeld and kept for acclimation period of 6 days. Rats were supplied by standard diet (ad libitum) RMH-B, pellet diameter 10 mm from Hope Farms, Woerden, and The Netherlands. Rats were provided (ad libitum) with tap water throughout the study period.

Undiluted test substance was evenly spread on surgical gauze (5×5 cm and 5×3.5 cm for males and females respectively) that was fixed to aluminum foil with a drop of Vaseline. Again with a drop of Vaseline this patch was attached to flexible bandage which was applied to clipped area of trunk of each animal and fixed with adhesive tape approximately 10% of the total body surface area.

Monitored for effects included clinical observations, body weights and gross pathology. The treated skin surface of the animals revealed no irritation. In addition, observations regarding changes of treated surface were performed following bandage removal and on 4, 7 and 14. No mortalities occurred during exposure and 14 day exposure period. No signs of systemic toxicity were observed during exposure and 14 day observation period. Weekly group mean body weight gain was normal.

All surviving animals were sacrificed by Co2 asphyxiation and subjected to necropsy. Macroscopic examination at necropsy of all animals at the end of the study revealed no test substance related gross abnormalities.

Based on the results of this the dermal LD0 of TPnB in male and female rats was > 2000 mg/kg.