Reaction mass of oxydiethylene dibenzoate and oxydipropyl dibenzoate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

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:

other: The study was conducted according to OECD, EC, EPA, and Japanese test guidelines, and in compliance with GLP.

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 2-45

IUPAC Name:

Benzoflex 2-45

Constituent 2

Reference substance name:

Oxydiethylene dibenzoate

EC Number:

204-407-6

EC Name:

Oxydiethylene dibenzoate

Cas Number:

120-55-8

Molecular formula:

C18H18O5

IUPAC Name:

2-[2-(benzoyloxy)ethoxy]ethyl benzoate

Details on test material:

- Name of test material (as cited in study report): Benzoflex 2-45 (Diethylene glycol dibenzoate DEGDB)
- 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, Cambrigeshire, England
- Age at study initiation: 11 to 13 weeks
- Weight at study initiation: 2.5 to 3.1 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 - 74%
- 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): Approximately 0.5 mL

Duration of treatment / exposure:

4 hours

Observation period:

72 hours

Number of animals:

Six males
(Note that the "animal management " section of the report states that 3 animals were used, however the results section lists data from 6 animals).

Details on study design:

TEST SITE
- Area of exposure: 25 mm 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:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

other: Not applicable

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

other: Not applicable

Remarks on result:

no indication of irritation

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:

other:

Remarks:

EU-GHS criteria not met

Conclusions:

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

Executive summary:

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

No dermal reactions were observed following a single semi-occlusive application of DEGDB to intact rabbit skin for four hours. DEGDB is not irritant to the skin.

DEGDB is not considered to be a primary skin irritant