Registration Dossier

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 guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Qualifier:
according to
Guideline:
EPA OPPTS 870.1200 (Acute Dermal Toxicity)
Qualifier:
according to
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
GLP compliance:
yes (incl. certificate)
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
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 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:
No signs of toxicity, but signs of irritation (reversible).
Body weight:
The body weight development of all male animals was within the expected range.
4 of 5 female animals showed slight weight loss during the first week, but all female animals showed weight gain in the second week of observation. The toxicological relevance of this finding cannot clearly be concluded.
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.