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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:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
Data is from HSDB database.

Data source

Reference
Reference Type:
other: Authoritative database.
Title:
Determination of Acute oral toxicity.
Author:
U.S. National Library of Medicine, National Institutes of Health, Health & Human Services
Year:
2017
Bibliographic source:
HSDB, U.S. National Library of Medicine, National Institutes of Health, Health & Human Services, 2017

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: as mentioned below
Principles of method if other than guideline:
Acute oral toxicity in rats was perfromed using 2-Butoxyethanol.
GLP compliance:
not specified
Test type:
other: not specified
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Details on test material:
- Name of test material (as cited in study report):2-Butoxyethanol (Ethylene glycol monobutyl ether)
- Molecular formula: C6H14O2
- Molecular weight: 118.175 g/mol
- Substance type: Organic
- Physical state: Liquid
Specific details on test material used for the study:
- Name of test material (as cited in study report):2-Butoxyethanol (Ethylene glycol monobutyl ether)
- Molecular formula: C6H14O2
- Molecular weight: 118.175 g/mol
- Substance type: Organic
- Physical state: Liquid

Test animals

Species:
rat
Strain:
Wistar
Sex:
male

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
not specified
Details on oral exposure:
Not specified
Doses:
670, 1310, 2560 and 5000 mg/kg
No. of animals per sex per dose:
10 male rats in 4 group
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs and gross pathology was observed

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
1 590 mg/kg bw
Based on:
test mat.
95% CL:
> 1 110 - < 2 270
Remarks on result:
other: 50 % mortality was observed
Mortality:
Mortality was observed in 3 rats at the 1310 mg/kg dose level, 8 rats at the 2560 mg/kg dose level and all rats at the 5000 mg/kg dose level.
Clinical signs:
Piloerection and lethargy was observed for 1310, 2560 mg/kg, flaccidity at the 2560 mg/kg and ataxia at the 5000 mg/kg concentrations.
Body weight:
No data available
Gross pathology:
Dark liver and kidney was observed in 3 rats, and enlarged kidney in 4 rats at the 1310 mg/kg dose level along with red intestine in 1, blood in the bladder in all rats at the 2560 mg/kg dose level blood in the bladder in all rats at the 5000 mg/kg dose level.

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
The LD 50 value for acute oral toxicity for 2-Butoxyethanol (111-76-2) was considered to be 1,590 mg/kg for rats.
Executive summary:

Acute oral toxicity to albino rats (wistar strain) was observed for 2-Butoxyethanol (111-76-2) in 4 groups of 10 male albino rats. The test concentration of 670, 1310, 2560 and 5000 mg/kg was used in 4 groups of 10 male albino rats. Mortality was observed in 3 rats at the 1310 mg/kg dose level, 8 rats at the 2560 mg/kg dose level and all rats at the 5000 mg/kg dose level. Piloerection and lethargy was observed for 1310, 2560 mg/kg,flaccidity at the 2560 mg/kg and ataxia at the 5000 mg/kg concentrations. Dark liver and kidney was observed in 3 rats, and enlarged kidney in 4 rats at the 1310 mg/kg dose level along with red intestine in 1, blood in the bladder in all rats at the 2560 mg/kg dose level blood in the bladder in all rats at the 5000 mg/kg dose level.

On the basis of these observation, the LD 50 value for acute oral toxicity for 2-Butoxyethanol (111-76-2) was considered to be 1,590 mg/kg for rats.Based on the value, 2-Butoxyethanol (111-76-2) was considered to be toxic to rats and can be classified in "acute category 4" as per the CLP regulations.