Dimethyl 3-oxoglutarate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2001

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Report date:

2001

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

yes

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Dimethyl 3-oxoglutarate

EC Number:

217-385-8

EC Name:

Dimethyl 3-oxoglutarate

Cas Number:

1830-54-2

Molecular formula:

C7H10O5

IUPAC Name:

dimethyl 3-oxoglutarate

Details on test material:

- Name of test material (as cited in study report): LZ409
- Molecular formula (if other than submission substance):
- Molecular weight (if other than submission substance):
- Smiles notation (if other than submission substance):
- InChl (if other than submission substance):
- Structural formula attached as image file (if other than submission substance):
- Substance type: organic
- Physical state: light yellow liquid
- Analytical purity:
- Impurities (identity and concentrations):
- Composition of test material, percentage of components:
- Isomers composition:
- Purity test date:
- Lot/batch No.:
- Expiration date of the lot/batch:
- Radiochemical purity (if radiolabelling):
- Specific activity (if radiolabelling):
- Locations of the label (if radiolabelling):
- Expiration date of radiochemical substance (if radiolabelling):
- Stability under test conditions: stable
- Storage condition of test material: room temperature
- Other: stored in dark

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source:
- Age at study initiation: 9 weeks old
- Weight at study initiation: 197-273 g
- Fasting period before study:
- Housing: individually in cages (stainless steel grid tops, and solid bottoms with wood shavings)
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-22
- Humidity (%): 56 (mean)
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 h/12 h

IN-LIFE DATES: From: To:

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: ca. 2 % of total body surface
- % coverage:
- Type of wrap if used: gauze patch secured with Micropore semi-occlusive tape and a trip of non-irritating occlusive tape wound round the trunk.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with distilled water
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg; ca. 91 mg/cm2.
- Concentration (if solution): pure substance
- Constant volume or concentration used: yes
- For solids, paste formed: no

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

Duration of exposure:

24 hours

Doses:

2000 mg/kg

No. of animals per sex per dose:

5 male / 5 female

Control animals:

no

Details on study design:

- Duration of observation period following administration: 15 days
- Frequency of observations and weighing: Day 1, Day 8, Day 15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Statistics:

No formal statistical analysis was conducted.

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:

All the animals were examined for reaction to treatment. The onset, intensity and duration of any sings were recorded.
The clinical observations were conducted frequently on the day of dosing and daily thereafter until necropsy on the Day 15.

Clinical sings were limited to red discharge from the eyes and nose only on the day of dosing (Day 1).

Body weight:

Body weight gain was considered to have been satisfactory.

Gross pathology:

Apart from brown staining on the skin of one male animal there were no findings noted at necropsy.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Not classified as acute dermal toxic substance according to EU legislation.