Dimethyl 3-oxoglutarate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1980

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Non-GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1980

Report date:

1980

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: DOT

GLP compliance:

no

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): P 5110
- 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: clear 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: dark glass bottle

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Morton Commercial Rabbits, Personage Farm, Stansted, Essex
- Age at study initiation:
- Weight at study initiation: 3.00-3.49 kg
- Housing: Caged individually in grid floor cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): not controlled, but recorded twice daily (except that lower limit of 12 °C was automatically imposed)
- Humidity (%): not controlled, but recorded twice daily
- Air changes (per hr): fan controlled air circulation was provided
- Photoperiod (hrs dark / hrs light): light between 06.00-20.00 hours.

IN-LIFE DATES: From: To:

Test system

Type of coverage:

occlusive

Preparation of test site:

other: left side of the clipped area was left intact, the right side was abraded

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml 1 intact and 1 abraded side
- Concentration (if solution): -

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

Duration of treatment / exposure:

4 hours

Observation period:

0 h, 4h 24h, 48 h, 72 h

Number of animals:

6 female

Details on study design:

TEST SITE
- Area of exposure: 6 cm2
- % coverage: full
- Type of wrap if used: gauze, cotton wool (1 g), adhesive strip.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): warm water
- Time after start of exposure: 4 hours

SCORING SYSTEM:
The sum of 4, 24 and 48 hour values for erythema and oedema on intact and abraded skin (72 scores) was divided by 36 to give the primary irritation index of the test article. The test article was classified as follows:

Primary irritation index: 0; Classification of irritancy: Non-irritant;
> 0 to 2 ; Mild irritant
> 2 to 5; Moderate irritant
> 5 Severe irritant

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

animal 1-6

Time point:

other: 4, 24, 48, 72 h

Score:

0

Max. score:

72

Results 2

Irritation parameter:

edema score

Basis:

mean

Remarks:

animal 1-3

Time point:

other: 4, 24, 48, 72 h

Score:

0

Max. score:

72

Results 3

Irritation parameter:

edema score

Basis:

animal #5

Time point:

other: 4 h

Score:

1

Max. score:

72

Results 4

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

other: 4, 24, 48 h

Score:

0.1

Irritant / corrosive response data:

Very slight oedema noted at the 4 hour observation in 1 of the 6 animals was the only skin reaction recorded.
A primary irritation index of 0.1 was calculated.

The substance did not produce a corrosive response as defined by the Code of Federal Regulations, Title 49, Part 173, 1976.

Applicant's summary and conclusion

Interpretation of results:

slightly irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Slightly irritating.
Classification is not needed for skin irritation according to EU legislation.