2-(2-methoxyethoxy)ethanol

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1981

Reliability:

1 (reliable without restriction)

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:

not specified

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

2-(2-methoxyethoxy)ethanol

EC Number:

203-906-6

EC Name:

2-(2-methoxyethoxy)ethanol

Cas Number:

111-77-3

Molecular formula:

C5H12O3

IUPAC Name:

2-(2-methoxyethoxy)ethanol

Details on test material:

- Name of test material (as cited in study report): Diethylene glycol mono methyl ether
- Physical state: liquid
- Analytical purity: >99.5%
- Other: EK Acc #:907229. TEX#:79-1. PM#:1798. HS&HFL La#:79-431

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 close 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

Duration of exposure:

24 hours

Doses:

1260, 2520, 5040, 10080, 20160 mg/kg (based on 10.5, 21, 42, 84, 168mmol/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:

9 404 mg/kg bw

95% CL:

> 6 696 - < 13 212

Clinical signs:

other: At lower doses: anorexia, slight depression, cyanosis, ataxia, soft faeces. At higher doses: salivation, nasal discharge, iritis, significant depression, laboured 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)	10.5	21	42	84	168
Number of rabbits examined/with pathology	5/1	5/1	5/2	5/4	5/5
Thymus -  edema & Haemorrhage	1
Lungs - brown discoloration				2	3
Liver - discoloured- brown & green mottled			2	1
Liver - brown					3
Kidney - discoloured (pale, beefy, red)			1	1
Kidney - texture mushy					1
Kidney - increased vascularity on surface				1
Kidneys - cortex - appears wide		1		1
Kidneys - cortex - appears dark red					1
Kidney - medulla - dark red				1
Stomach - haemorrhage					1
Duodenum - haemorrhage				3	2
Thorax/abdomen -contained dark brown fluid				2	2
All organs pale				1

Based on this pathology data, a no effect level of 21mmol/kg (2520mg/kg) could be established based on the findings at lower levels being random occurences (no kidney effects at next dose and no other thymus findings)

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 -(2 -butoxyethoxy)ethanol. 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: 9404mg/kg