Dimethyl glutarate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

January 09 to March 02, 1987

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study according to OECD Guideline 404 under GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1987

Report date:

1987

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Reaction mass of dimethyl adipate and dimethyl glutarate and dimethyl succinate

EC Number:

906-170-0

IUPAC Name:

Reaction mass of dimethyl adipate and dimethyl glutarate and dimethyl succinate

Test material form:

other: liquid

Details on test material:

See information in the field "Confidential details on test material"

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: L'Abbaye de Bellefontaine, F-49122 Begrolles en Mauges, France
- Weight at study initiation: 2.5 ± 0.1 kg
- Housing: Individually in polystyrene cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ±3 °C
- Humidity (%): 50 ± 20
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit):0.5 ml

Duration of treatment / exposure:

4 hours

Observation period:

1h, 24h, 48 h, and 72 h after exposure termination;

Number of animals:

3 animals

Details on study design:

TEST SITE
- Area of exposure: right flank
- coverage: 6 cm²
- Type of wrap if used: gauze patch held in place with semi-occlusive dressing

SCORING SYSTEM:
Erythema score: 0-4
Edema score: 0-4

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Remarks:

of 3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Remarks:

of 3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Remarks:

of 3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Results 4

Irritation parameter:

edema score

Basis:

animal #1

Remarks:

of 3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Results 5

Irritation parameter:

edema score

Basis:

animal #2

Remarks:

of 3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Remarks:

of 3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: OECD GHS

Conclusions:

Under the conditions of this assay, the test article has no skin irritating potential.

Executive summary:

DBE has been tested for skin irritation on 3 New Zealand White rabbits according to OECD guideline n° 404 and EU guideline n° B.4 (Draize Method) in compliance with Good Laboratory Practice. The rabbits received a dermal dose of 0.5 ml of DBE on a gauze on intact and abraded skin sites under an semiocclusive dressing for a period of 24 hours. Scores for erythema and oedema were measured 1, 24, 48 and 72 hours after patch removal and primary cutaneous index was calculated (maximum possible index =12)

No sign of dermal irritation (score = 0 for erythema and oedema) was observed for intact skin site of the 3 rabbits at any reading time. Primary Irritation Index was = 0.0. No other signs of intoxication were observed.

Based on these results DBE is not classified irritating to skin according to the criteria of the Directive 67/548/CEE and according to EU Regulation 1272/2008 (CLP).