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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:
1994
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study with full report available

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report date:
1994

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
, use of guinea pig as test species
Qualifier:
according to guideline
Guideline:
other: US DoT CFR title 49, section 173.132
Deviations:
yes
Remarks:
, use of guinea pig as test species
GLP compliance:
yes (incl. QA statement)
Test type:
fixed dose procedure
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
2-butoxyethanol
EC Number:
203-905-0
EC Name:
2-butoxyethanol
Cas Number:
111-76-2
Molecular formula:
C6H14O2
IUPAC Name:
2-butoxyethanol
Details on test material:
- Name of test material (as cited in study report): Ethylene glycol monobutyl ether
- Physical state: colourless liquid
- Analytical purity: 99.8% (analysis by GC/FID). Confirmed GCMS against library spectra.
- Purity test date: February 1994
- Lot/batch No.: 9792
- Stability under test conditions: Analytical purity determined to be unaltered at start and end of study

Test animals

Species:
guinea pig
Strain:
Hartley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Laboratories, Kingston, NY
- Age at study initiation: males 5-6 weeks, females 6-7 weeks
- Weight at study initiation: Males 380-454g, females 366-407g
- Fasting period before study: no
- Housing: individually in stainless steel mesh cages
- Diet (e.g. ad libitum): Agway Prolab animal diet (RMH 3000) ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: 2 weeks

ENVIRONMENTAL CONDITIONS
- Temperature (°F): 69-72
- Humidity (%): 57-59%
- Photoperiod (hrs dark / hrs light): 12/12hrs

IN-LIFE DATES: From: 1 March 1994 To: 15 March 1994

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: Dorsal skin, prepared using electric clippers.
- Type of wrap if used: fibre pad under an occlusive wrap (not specified)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes
- Time after start of exposure: 24 hours
Duration of exposure:
24 hours
Doses:
2000mg/kg only
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations 1, 2, 3-4 hours after application then daily. Body weight on days 0, 7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: observations of skin, fur, faeces, eyes, mucous membranes, respiratory, circulatory, autonomic and central nervous systems, sonatomotor activity and behaviour.
Statistics:
no statistical analysis required on results.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD0
Effect level:
> 2 000 mg/kg bw
Mortality:
None.
Clinical signs:
None
Body weight:
Appeared normal
Gross pathology:
No treatment related changes noted.
Other findings:
none

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
There was no evidence of toxicity associated with the percutaneous exposure of guinea pigs to 2-butoxyethanol at a dose of 2000mg/kg.
Executive summary:

A guideline GLP acute dermal toxicity study was conducted in male and female guinea pigs who were adminstered a single topical dose of 2 -butoxyethanol for 24 hours under occluded conditions of exposure. No clinical signs of toxicity were seen during a 14 day observation period. All animals gained weight and no signs of organ toxicity were noted at necropsy.

Synopsis

LD0 (dermal, guinea pig) > 2000mg/kg

NOAEC (dermal , guinea pig) >2000mg/kg