2-(benzylmethylamino)ethyl acetoacetate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

February 8th 2011 - February 23rd 2011

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2011

Report date:

2011

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1200 (Acute Dermal Toxicity)

Test guideline 3

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2-(benzylmethylamino)ethyl acetoacetate

EC Number:

259-197-9

EC Name:

2-(benzylmethylamino)ethyl acetoacetate

Cas Number:

54527-65-0

Molecular formula:

C14H19NO3

IUPAC Name:

2-[benzyl(methyl)amino]ethyl 3-oxobutanoate

Details on test material:

- Name of test material (as cited in study report): 2-(N-benzyl-N-methylamino)ethyl acetoacetate
- Physical state: Liquid
- Composition of test material, percentage of components: 96.5%
- Lot/batch No.: 112/2010
- Expiration date of the lot/batch: December 2011
- Stability under test conditions: stable
- Storage condition of test material: at room temperature, protected from light

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River, 97633 Sulzfeld, Germany
- Age at study initiation: Males: 8-9 weeks old; Females: 14 weeks old
- Weight at study initiation: Males: 238-260 g; Females: 214-230 g.
- Fasting period before study:
- Housing:
- Diet (e.g. ad libitum):
- Water (e.g. ad libitum): sulphur acidified to a pH of about 2.8
- Acclimation period:

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3°C
- Humidity (%): 55 +/- 10%
- Air changes (per hr): 10 x / hour
- Photoperiod (hrs dark / hrs light): 12 hours light, 12 hours dark

IN-LIFE DATES: From: To:

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: about 10% of total body surface
- % coverage: not lss than 10%
- Type of wrap if used: dressing (gauze-dressing and not-irritating tape fixed with additional dressing.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): aqua at injectionem
- Time after start of exposure: 24 hours
- Observation period: 14 days

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/Kg

No VEHICLE

Duration of exposure:

24 hours

Doses:

2000 mg/Kg bw

No. of animals per sex per dose:

5 males and 5 females

Control animals:

no

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality

Clinical signs:

other: No signs of toxicity, but signs of irritation (reversible).

Gross pathology:

3 animals showed red spots in the lungs, which are considered to be not test item related.
No specific gross pathological changes were recorded for any other animal.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

2 (N-Benzyl-N-methylamino) ethyl acetoacetate has no obligatory labelling requirement for toxicity and is unclassified.