2-methoxyethanol

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Full study report available with detailed information on study. Not to GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1981

Report date:

1981

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

2-methoxyethanol

EC Number:

203-713-7

EC Name:

2-methoxyethanol

Cas Number:

109-86-4

Molecular formula:

C3H8O2

IUPAC Name:

2-methoxyethanol

Details on test material:

- Name of test material (as cited in study report): ethylene glycol monomethyl ether
- Physical state: liquid
- Analytical purity: >99.5%, confirmed by GC analysis
- Source: Texas Eastman
- Lot/batch No.: EK Acc#:902381. TEX#:56-22. PM#:45. HS&HFL lab#:79-414

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Dutchland Laboratory animals Inc, Denver, PA
- Age and weight at study initiation: no data
- Housing: metal cages
- Diet (e.g. ad libitum): Purina lab chow, ad libitum
- Water: ad libitum
- Acclimation period: 3 weeks


ENVIRONMENTAL CONDITIONS
- no data

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: dorsal
- % coverage: 3.5x4 inch area.
- Type of wrap if used: Pad in sloce contact with skin occluded with dental dam wrap. Substance injected under dam into pad then dam edges sealed with adhesive tape.


REMOVAL OF TEST SUBSTANCE
- Washing (if done): Wiped with cotton wool. No washing.
- Time after start of exposure: 24 hours


TEST MATERIAL
- Amount(s) applied (volume or weight with unit):
- Concentration (if solution):
- Constant volume or concentration used: yes/no
- For solids, paste formed: yes/no


VEHICLE
- Amount(s) applied (volume or weight with unit):
- Concentration (if solution):
- Lot/batch no. (if required):
- Purity:

Duration of exposure:

24 hours

Doses:

395, 798, 1596, 3192, 6384, 12768 mg/kg (based on 5.2, 10.5, 21, 42, 84, 168 mmol/kg)

No. of animals per sex per dose:

5

Control animals:

other: no but other substances tested in same study acted as reference 'controls'

Details on study design:

- Duration of observation period following administration: 14 days.
- Frequency of observations and weighing: Twice per day for mortality, once per day for abnormal signs. Body weights recorded before treatment and on days 7 & 14 (end of study).
- Necropsy of survivors performed: yes as well as animals that died.
- Other examinations performed: clinical signs, body weight,organ weights, gross pathology

Statistics:

LD50 calculated using the method of Thompson and Weil (Biometrics 8, 51-4 (1952))

Results and discussion

Effect levels

Sex:

male

Dose descriptor:

LD50

Effect level:

3 930 mg/kg bw

95% CL:

> 2 979 - < 5 138

Clinical signs:

other: At lower doses: anorexia, slight depression, cyanosis, ataxia, soft faeces. At higher doses: salivation, nasal discharge, iritis, significant depression, llaboured breathing, prostration.

Gross pathology:

See table below

Other findings:

- Potential target organs: see table below

Any other information on results incl. tables

Summary of gross pathology:

Dose (mmol/kg)	5.2	10.5	21	42	84	168
Number of rabbits examined/with pathology	5/1	5/1	5/0	5/1	5/5	5/5
Lungs - red mottled, pale area						1
Lungs - firm consolidated area				1
Liver - irregular shape					1
Liver - dark areas						2
Liver - margin dark					1
Liver - mottled, dark red				1	1	1
Kidneys - outer surface vascular	1			1		1
Kidneys - outer surface pitted					1
Kidneys - outer surface haemorrhagic					1
Kidney - pelvis pale, wide cortex			1		2	1
Kidney - pelvis pale, wide medulla						1
Kidney - pelvis pale		1
Intestines - large and small, dark brown						2
Intestines - large and small, vascular					1

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Executive summary:

In a single 24 hour exposure dermal toxicity study, male NZ white rabbits were exposed to 2 -methoxyethanol. The LD50 value is shown below. Sub-lethal effects included at lower doses anorexia, slight depression, cyanosis, ataxia, soft faeces, and at higher doses salivation, nasal discharge, iritis, significant depression, llaboured breathing, and prostration.. Based on the results of this study, this substance would not be classified for acute toxicity in accordance with the current EU guidelines.

Results synopsis

LD50: 3930mg/kg