Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1987
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Report does not specify about GLP but equivalent to OECD guideline no 401 and sufficient data is available for the interpretation of study results.
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study

Data source

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

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Principles of method if other than guideline:
not applicable
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
2-hexyloxyethanol
EC Number:
203-951-1
EC Name:
2-hexyloxyethanol
Cas Number:
112-25-4
Molecular formula:
C6H13OCH2CH2OH
IUPAC Name:
2-hexyloxyethanol
Details on test material:
- Name of test material (as cited in study report): Hexyl CELLOSOLVE (Ethylene glycol monohexyl ether)
- Physical state: Clear, non-viscous liquid
- Lot/batch No.: S074565

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Not specified in the report
- Age at study initiation: Not specified in the report
- Weight at study initiation: 200-300 g
- Fasting period before study: Overnight
- Housing: Not specified in the report
- Diet ( ad libitum): Not specified in the report
- Water ( ad libitum): Not specified in the report
- Acclimation period: Not specified in the report


ENVIRONMENTAL CONDITIONS
- Temperature (°C): Not specified in the report
- Humidity (%): Not specified in the report
- Air changes (per hr): Not specified in the report
- Photoperiod (hrs dark / hrs light): Not specified in the report

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
Sprague-Dawley albino rats, weighing between 200 and 300 g, receive the test material by stomach intubation with a ball-end stainless steel needle. The sample is injected through the needle by means of a syringe and doses are varied by adjusting the volume of the test material or its dilution. The rats are fasted overnight before dosing. Five males and 5 females are included on each level used for the LD50 calculations.

Doses:
For male rats: 2.00 ml/kg, 1.41 ml/kg, 1.00 ml/kg and 0.50 ml/kg
For female rats: 4.0 ml/kg, 2.0 ml/kg, 1.0 ml/kg, 0.71 ml/kg, 0.50 ml/kg and 0.25 ml/kg
No. of animals per sex per dose:
5/sex/dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Weekly
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weights and gross pathology
Statistics:
LD50's and the estimated LD50 slopes are calculated by the moving average method (Thompson, 1947; Weil, 1983) and are based on a 14-day observation period.

Results and discussion

Preliminary study:
none
Effect levelsopen allclose all
Sex:
male
Dose descriptor:
LD50
Effect level:
1.67 mL/kg bw
95% CL:
1.43 - 1.96
Remarks on result:
other: 1484 mg/kg
Sex:
female
Dose descriptor:
LD50
Effect level:
0.83 mL/kg bw
95% CL:
0.71 - 0.97
Remarks on result:
other: 738 mg/kg
Mortality:
For male rats: 2.00 ml/kg (5/5), 1.41 ml/kg (0/5), 1.00 ml/kg (5/0) and 0.50 ml/kg (0/3)
For female rats: 4.0 ml/kg (3/3), 2.0 ml/kg (3/3), 1.0 ml/kg (5/5), 0.71 ml/kg (0/0), 0.50 ml/kg (0/0) and 0.25 ml/kg (0/0)
Clinical signs:
other: Signs of toxicity included sluggishness, lacrimation, drooping eyelids, piloerection, labored breathing, red perinasal discharge (in 2) and prostration. Deaths occurred at 3 hours to 3 days. Survivors recovered at one to 3 days.
Gross pathology:
At necropsy, there were mottled and red lungs, red or liquid-filled stomachs, urinary bladders with red fluid and one liver nodule.
Other findings:
None

Any other information on results incl. tables

none

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
Based on the results of this study acute oral LD50 for male and female rats receiving peroral doses of Hexyl CELLOSOLVE is 1.67 ml/kg (1484 mg/kg) and 0.83 ml/kg (738 mg/kgbw ) respectively.
Executive summary:

Ethylene glycol monohexyl ether was evaluated for acute oral test in rats. Sprague-Dawley albino rats, weighing between 200 and 300 g, received the Hexyl CELLOSOLVE (Ethylene glycol monohexyl ether) by stomach intubation with a ball-end stainless steel needle. The sample was injected through the needle by means of a syringe and doses are varied by adjusting the volume of the test material or its dilution. The rats were fasted overnight before dosing. Five males and 5 females are included on each level used for the LD50 calculations.

Signs of toxicity included sluggishness, lacrimation, drooping eyelids, piloerection, labored breathing, red perinasal discharge (in 2) and prostration. Deaths occurred at 3 hours to 3 days. Survivors recovered at one to 3 days. All survive animals gained body weights during 14 days of observation period. At necropsy, there were mottled and red lungs, red or liquid-filled stomachs, urinary bladders with red fluid and one liver nodule.

 

Based on the results of this study acute oral LD50 for male and female rats receiving peroral doses of Hexyl CELLOSOLVE is 1.67 ml/kg (1484 mg/kg) and 0.83 ml/kg (738 mg/kg bw) respectively.