2-[2-(dimethylamino)ethoxy]ethanol

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Unspecified to 1986-08-25

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study report without statement of guideline used for study or certification of following GLP; however, the methodology provided was equivalent to OECD 402.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

Report date:

1986

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

yes

Remarks:

Clinical observations were made before dose (0 days) and at 7 and 14 days instead of daily.

Principles of method if other than guideline:

N/A

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

2-[2-(dimethylamino)ethoxy]ethanol

EC Number:

216-940-1

EC Name:

2-[2-(dimethylamino)ethoxy]ethanol

Cas Number:

1704-62-7

Molecular formula:

C6H15NO2

IUPAC Name:

2-[2-(dimethylamino)ethoxy]ethan-1-ol

Constituent 2

Reference substance name:

DMEE

IUPAC Name:

DMEE

Details on test material:

- Name of test material (as cited in study report): DMEE (Dimethylaminoethoxyethanol)
- Molecular formula: (CH3)2NCH2CH2OCH2CH2OH
- Substance type: Pure active substance
- Physical state: liquid (amber, non-viscous)
- Analytical purity: 97.6
- Stability under test conditions: Stable for years as both undiluted test material and diluted in water.

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: between 2.0 and 3.0 kg

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: Trunk
- % coverage: N/A
- Type of wrap if used: Vetrap Bandaging Tape wrapped over the impervious sheeting of the intact, clipped skin

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Excess fluid removed to diminish ingestion
- Time after start of exposure: 24 hrs

Duration of exposure:

24 hrs

Doses:

Males: 0.50, 1.00, 1.41, and 2.00 mL/kg (the last dose was inferred by reviewer from lower doses and LD50; first number is erased in study's table).
Females: 0.50, 1.00, 2.00 (this dose inferred by reviewer from other doses and LD50; first number is erased in study's table), and 4.00 mL/kg.

No. of animals per sex per dose:

5 males and 5 females were included on each level for the LD50 calculation.

Control animals:

yes, concurrent no treatment

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: weighing at 0 days (before dose), 7 days and 14 days (just prior to sacrifice).
- Necropsy of survivors performed: yes

Statistics:

Moving average method (Thompson, 1947 (reference in OECD 402); Weil, 1983).

Results and discussion

Preliminary study:

N/A

Effect levels

Effect levels 1

Sex:

male

Dose descriptor:

LD50

Effect level:

1.74 mL/kg bw

Based on:

test mat.

95% CL:

1.5 - 2.01

Remarks on result:

other: Using the density for DMEE of 0.95 g/mL to convert to mg/kg bw resulted in a LD50 value of 1663 mg/kg bw.

Effect levels 2

Sex:

female

Dose descriptor:

LD50

Effect level:

2.14 mL/kg bw

Based on:

test mat.

95% CL:

1.45 - 3.17

Remarks on result:

other: Using the density for DMEE of 0.95 g/mL to convert to mg/kg bw resulted in a LD50 value of 2033 mg/kg bw.

Mortality:

Time of death ranged from 1 to 4 days.
- Males: 4/5 of the 2.00 mL/kg group died, 0/5 of the 1.41 mL/kg group, 0/5 of the 1.00 mL/kg group, 0/5 of the 0.50 group.
- Females: 5/5 of the 4.00 mL/kg group, 2/5 of the 2.00 mL/kg group.

Clinical signs:

other: Local dermal effects included: erythema, edema, necrosis, ecchymosis, fissuring, ulceration, desquamation and scabs. Dermal reactions persisted through 14 days. Salvation, sluggishness, unsteady gait, red discharge (from nose and mouth), tremors (in 2) an

Gross pathology:

Gross pathology findings included red and mottled lungs, red tracheas, a few discolored livers and kidneys, and subcutaneous edema.

Other findings:

N/A

Any other information on results incl. tables

The author of the study concluded that DMEE was moderately toxic following its administration by single dermal application. The criteria used for interpretation of results is listed above under "Any other information on materials and methods incl. tables".

Applicant's summary and conclusion

Conclusions:

The LD50 for percutaneous exposure to male rabbits was 1.74 mL/kg (1663 mg/kg bw) and to female rabbits was 2.14 mL/kg (2033 mg/kg bw). Severe skin irritation was apparent on each rabbit through death or sacrifice at 14 days.