Oxydipropyl dibenzoate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation / corrosion, other

Remarks:

in vivo study performed

Type of information:

experimental study

Adequacy of study:

key study

Study period:

17 July 1997 - 20 July 1997

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1998

Report date:

1998

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EPA OTS 798.4470 (Acute Dermal Irritation)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 4

Qualifier:

according to guideline

Guideline:

other: Japanese Ministry of Agriculture Forestry and Fisheries Requirements for Safety Evaluation of Agricultural Chemicals and Testing Guidelines for Toxicology Studies, Acute Dermal Irritation Study 59 NohSan No. 4200 Agricultural Production Bureau Jan 28 1985

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Benzoflex 9-88

IUPAC Name:

Benzoflex 9-88

Constituent 2

Reference substance name:

Oxydipropyl dibenzoate

EC Number:

248-258-5

EC Name:

Oxydipropyl dibenzoate

Cas Number:

27138-31-4

Molecular formula:

C20H22O5

IUPAC Name:

oxydipropyl dibenzoate

Details on test material:

- Name of test material (as cited in study report): Benzoflex 9-88 (Dipropylene glycol dibenzoate DPGDB)
- Physical state: Clear colourless liquid
- Storage condition of test material: Room temperature

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Interfauna (UK) Ltd., Huntingdon, Cambridgeshire, England
- Age at study initiation: 10 to 12 weeks.
- Weight at study initiation: 2.4 to 2.8 kg
- Housing: Individually housed in metal cages with perforated floors
- Diet: access to SDS Stanrab (P) SQC Rabbit diet (ad libitum)
- Water (e.g. ad libitum): access to mains drinking water (ad libitum)
- Acclimation period: 14 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 15.5 to 21.5°C
- Humidity (%): 57 to 74%
- Air changes (per hr): 19
- Photoperiod: 12 hrs dark / 12 hrs light

- Air changes (per hr): approximately 19 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours artificial light per 24 hour period


IN-LIFE DATES: From: 17 July 1997 To: 20 July 1997

Test system

Type of coverage:

semiocclusive

Preparation of test site:

other: Hair removed with electric clippers

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

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

Duration of treatment / exposure:

4 hours

Observation period:

72 hours

Number of animals:

6 males

Details on study design:

TEST SITE
- Area of exposure: 25 x 25 mm
- Type of wrap if used: Semi-occlusive gauze pad.


REMOVAL OF TEST SUBSTANCE
- Washing (if done): Treatment site washed with physiological saline.
- Time after start of exposure: 4 hours


SCORING SYSTEM: Consistent with the scoring system described in OECD test guideline 404.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: All time points (1, 24, 48 and 72 hours after exposure)

Score:

0

Max. score:

0

Reversibility:

other: not applicable

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: All time points (1, 24, 48 and 72 hours after exposure)

Score:

0

Max. score:

0

Reversibility:

other: Not applicable

Irritant / corrosive response data:

No dermal reaction to treatment was observed in any animal throughout the study

Other effects:

There were no signs of toxicity or ill health in any rabbit during the observation period.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

A single semi-occlusive application of DPGDB to intact rabbit skin for four hours elicited no dermal reaction..

Executive summary:

A study was performed to assess the skin irritation potential of DPGDB to the rabbit. The study was conducted in accordance with OECD, EC, US EPA and Japanese test guidelines, and in compliance with GLP.

Approximately 0.5 mL of the test substance was applied under a semi-occlusive gauze pad to 6 rabbits;  after a period of 4 hours the application site was washed with physiological saline. The animals were then observed for a period of 72 hours.

No dermal reactions were observed following this single semi-occlusive application of DPGDB to intact rabbit skin for four hours.

There were no signs of toxicity or ill health in any of the rabbits during the observation period.

Therefore DPGDB is not irritating to the skin and is not considered to be a primary skin irritant.