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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1994
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline GLP study with full report available

Data source

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

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
, use of guinea pigs
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no

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): 2-butoxyethanol
- Physical state: liquid
- Analytical purity: 99.8%, analysis by GC/FID
- Lot/batch No.: 9792
- Stability under test conditions: Samples analysed at start and finish of study and found to be identical.

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: 5-7 weeks
- Weight at study initiation: males: 309-405g. Females: 310-375
- Fasting period before study: overnight
- Housing: individual, stainless steel mesh cages
- Diet (ad libitum): Agway Prolab animal diet RMH3000
- Water (ad libitum: tap (Monroe County water authority.
- Acclimation period: 5 days

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

IN-LIFE DATES: From: 1/3/94

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 10%, 20%, 40%. Measured to be 42.5%, 18.2% and 10.1% (wt/vol) mean
- Amount of vehicle (if gavage): 1.5 - 2.0ml
- Purity: distilled

MAXIMUM DOSE VOLUME APPLIED: 2.03ml
Doses:
500, 1000, 2000mg/kg nominal
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: 3 times on day of dosing, daily thereafter.
- frequency of weighing: days 0, 7, 14
- Necropsy of survivors performed: yes (and on those dying early.)
- Other examinations performed: clinical signs, body weight, gross pathology.
Statistics:
Mean and standard deviation

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD50
Effect level:
1 414 mg/kg bw
95% CL:
> 1 020 - < 1 961
Sex:
male/female
Dose descriptor:
LD0
Effect level:
500 mg/kg bw
Mortality:
Low dose: none
Mid dose: 1 out of 5 of each sex (deaths by day 3)
High dose: 3/5 males, all females (deaths within 1 day)
Clinical signs:
other: Low dose: Slight weakness on day of dosing only. Mid dose: moderate to severe weakness on day of dosing and prior to death. Male that died on day 3 showed severe weakness, gasping and red nasal discharge. All animals that survived appeared normal follo
Gross pathology:
Minor to moderate diffuse necrosis and minimal to minor haemorrhage in the gastric mucosa. Minimal to minor accumulation of mucoid contents in the duodenum.
Other findings:
no other significant findings reported.

Applicant's summary and conclusion

Interpretation of results:
harmful
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Substance is a gastrointestinal irritant, as evidenced by sialorrhea, staining of face with food and saliva and treatment related changes to the gastric mucosa. All abnormal clinical signs were either transient or noted prior to death. Substance shows an LD50 of 1414mg/kg
Executive summary:

A GLP guideline acute oral acute single dose toxicity study was performed in male and female guinea pigs and established an LD50 of 1414mg/kg across the two sexes. Those animals that did not die fully recovered from any adverse clinical effects within 6 days, even at the highest dose tested of 2000mg/kg. It was concluded that the substance is a gastrointestinal irritant, as evidenced by sialorrhea, staining of face with food and saliva and treatment related changes to the gastric mucosa but there was no evidence of any adverse effects on the red blood cells, suggesting that the species is resistant to such effects. Based on the results of this study, this substance would be classified 'harmful' for acute toxicity in accordance with the current EU guidelines GHS regulation, although this is not a preferred species for testing. Under the EH GHS classification regulation, it would be classified category 4.

Synopsis

Oral LD50 (guinea pig) = 1414mg/kg

Oral single dose NOAEC (guinea pig) = 500mg/kg