2-(1-methylethoxy)ethyl acetate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

12 Sept - 26 Sept 2012

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2012

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

adopted 24 February 1987

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Version / remarks:

2008

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

The Department of Health of the Government of the United Kingdom

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2-(1-methylethoxy)ethyl acetate

EC Number:

242-901-3

EC Name:

2-(1-methylethoxy)ethyl acetate

Cas Number:

19234-20-9

Molecular formula:

C7H14O3

IUPAC Name:

2-(propan-2-yloxy)ethyl acetate

Test material form:

liquid

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 57033
- Expiration date of the lot/batch: 25 November 2014

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature in the dark.

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Laboratories UK Ltd., Oxon, UK (strain: RccHanTM:WIST)
- Age at study initiation: 8 - 12 weeks
- Weight at study initiation: range of 200 - 300 g
- Housing: in suspended solid-floor polypropylene cages furnished with woodflakes, individual housing during exposure and in in groups of 5 per sex the rest of the study
- Diet: 2014C Teklad Global Rodent diet, ad libitum
- Water: ad libitum
- Acclimation period: st least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 -25°C
- Humidity (%): 30 - 70%
- Air changes (per hr): at least 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: at the back and flanks of the animals
- % coverage: 10
- Type of wrap if used: surgical gauze, secured with self-adhesive tape

REMOVAL OF TEST SUBSTANCE
- Washing: the exposed area and the surrounding hair was wipped with cotton wool moistened with distilled water
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2.13 mL/kg

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations were made 0.5, 1, 2 and 4 hours after dosing and subsequently every day, body weights were determined on day of dosing and on days 7 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, other: scoring for dermal irritation once daily for fourteen days

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No animal died during the study.

Clinical signs:

other: No signs of systemic toxicity could be observed.

Gross pathology:

No abnormalities were noted at necropsy.

Other findings:

- Other observations: There were no signs of dermal irritation.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

CLP: not classified
DSD: not classified