Registration Dossier
Registration Dossier
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EC number: 203-905-0 | CAS number: 111-76-2
Acute Toxicity: dermal
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:
- 1 994
- 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
- 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
Constituent 1
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:
- other: None
- 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
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