2-hexyloxyethanol

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1987

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: This study was not conducted in accordance with GLP but sufficient data is available for the interpretation of study results.

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

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 402 (Acute Dermal Toxicity)

Principles of method if other than guideline:

not applicable

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

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:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

Not specified in the report

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: Clipped intact skin of the trunk
- Type of wrap if used: Vetrap bandaging tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): not specified
- Time after start of exposure: 24 hours

Duration of exposure:

24 hours

Doses:

4 ml/kg, 2 ml/kg, 1 ml/kg and 0.5 ml/kg

No. of animals per sex per dose:

5/sex

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals observed daily and body weights taken weekly
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight and gross pathology

Statistics:

Means and standard deviations of animal body weights were calculated for descriptive purposes.

Results and discussion

Preliminary study:

none

Effect levels

Effect levels 1

Sex:

male

Dose descriptor:

LD50

Effect level:

0.81 mL/kg bw

95% CL:

0.59 - 1.12

Remarks on result:

other: calculated (757.35 mg/kg)

Effect levels 2

Sex:

female

Dose descriptor:

LD50

Effect level:

0.93 mL/kg bw

95% CL:

0.63 - 1.38

Remarks on result:

other: calculated (869.55 mg/kg)

Mortality:

Male: 4 ml/kg 5/5 , 2 ml/kg 5/5 , 1 ml/kg 4/5 and 0.5 ml/kg 0/5
Female: 4 ml/kg 5/5 , 2 ml/kg 5/5 , 1 ml/kg 3/5 and 0.5 ml/kg 0/5
Time to death ranged from one to 3 days. Survivors recovered at 2 to 4 days.

Clinical signs:

other: Local dermal effects included erythema, edema, ecchymosis, necrosis, desquamation, scabs and ulceration. A comatose appearance, red perinasal discharge, sluggishness and an unsteady gait were among the signs of toxicity observed.

Gross pathology:

Gross pathologic findings included mottled and pink to red lungs, red thymuses, a few red tracheas and dorsal alopecia.

Other findings:

None

Any other information on results incl. tables

none

Applicant's summary and conclusion

Interpretation of results:

Category 3 based on GHS criteria

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

By the percutaneous route, the LD50 for male rabbits was 0.81 ml/kg (calculated 757.35 mg/kg). The LD50 for females was 0.93 ml/kg (calculated 869.55 mg/kg)

Executive summary:

Ethylene glycol mono hexyl ether was evaluated for acute dermal test in rabbits. New Zealand White rabbits, weighing between 2.0 and 3.0 kg, were subjected to 24 hours of contact with the test material which was retained under impervious sheeting on the clipped, intact skin of the trunk. As necessary for larger doses, gauze was wrapped around the trunk over the sample to prevent leakage. Vetrap Bandaging Tape was wrapped over the impervious sheeting and the animal was returned to its cage for the contact period. Doses were varied by adjusting the volume or weight of the test material. Solids dosed as powders and were moistened with a sufficient amount of water or other suitable vehicle to form a paste. After the contact period, excess fluid was removed to diminish ingestion. Observations for skin reaction are made at one hour, 7 days and 14 days after the contact period. Five male and 5 females were included on each level used for the LD50 calculation.

By the percutaneous route, the LD50 for male rabbits was 0.81 ml/kg. The D50 for females was 0.93 ml/kg. Local dermal effects included erythema, edema, ecchymosis, necrosis, desquamation, scabs and ulceration.

 

A comatose appearance, red perinasal discharge, sluggishness and an unsteady gait were among the signs of toxicity observed. Time to death ranged from one to 3 days. Survivors recovered at 2 to 4 days. Gross pathologic findings included mottled and pink to red lungs, red thymuses, a few red tracheas and dorsal alopecia.

 

By the percutaneous route, the LD50 for male rabbits was 0.81 ml/kg (calculated 757.35 mg/kg). The LD50 for females was 0.93 ml/kg (calculated 869.55 mg/kg)