Reaction mass of 2-[2-(benzoyloxy)ethoxy]ethyl benzoate, 1-[2-(benzoyloxy)propoxy]propan-2-yl benzoate, and 2-[2-[2-(benzoyloxy)ethoxy]ethoxy]ethyl benzoate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

16 July 1997 - 30 July 1997

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study was conducted according to EPA, EEC, OECD, 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 798.1100 (Acute Dermal Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

Test guideline 4

Qualifier:

according to guideline

Guideline:

other: Japan Ministry of International Trade and Industry (MITI), Directive, concerning the conduct of acute toxicity studies.

Deviations:

no

GLP compliance:

yes

Limit test:

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:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan UK Ltd, Bicester, Oxon, England.
- Age at study initiation: seven to eight weeks
- Weight at study initiation: 230 to 261g
- Housing: Housed individually in metal cages with wire mesh floors.
- Diet (e.g. ad libitum): Standard laboratory rodent diet (Special Diet Services RM1(E) SQC expanded pellet), available ad libitum
- Water (e.g. ad libitum): Drinking water was made available ad libitum.
- Acclimation period: A minimum of six days.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 to 24.5°C
- Humidity (%): 45 - 63%
- Air changes (per hr): 10 to 15
- Photoperiod (hrs dark / hrs light): 12 hours per 24 hour period.

IN-LIFE DATES: From: 16 July 1997 To: 30 July 1997

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: 50 mm x 50 mm
- % coverage: Approximately 10% of the total body surface area
- Type of wrap if used: porous gauze held in place with a non irritating dressing, further covered by a waterproof dressing.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Skin washed with warm water (30°C to 40°C), then blotted dry with absorbent paper.
- Time after start of exposure:24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bodyweight
- Constant volume or concentration used: no (variable amount depending on bodyweight of test animal)

Duration of exposure:

24 hours

Doses:

Single limit dose of 2000 mg/kg bodyweight

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations for mortality and clinical signs were performed at least twice daily. Body weights were recorded on days 1 (Prior to dosing), 8, and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, macroscopic pathology

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

There were no deaths following a single dermal application of dose of DEGDB to a group of ten rats (five males and five females) at a dosage of 2000 mg/kg bodyweight.

Clinical signs:

other: There were no signs of systemic reaction to treatment observed throughout the study.

Gross pathology:

No abnormalities were recorded at the macroscopic examination on Day 15.

Applicant's summary and conclusion

Interpretation of results:

other:

Remarks:

EU-GHS criteria not met

Conclusions:

The acute lethal dermal dose to rats of DEGDB was demonstrated to be greater than 2000 mg/kg bodyweight.

Executive summary:

An acute dermal toxicity study in rats was performed to determine the toxicity by dermal exposure of the test material DEGDB. The study was conducted according to international test guidelines, and in compliance with GLP.

Ten rats (five males and five females) were exposed to a 2000 mg/kg dose of DEGDB by the dermal route for 24 hours, then observed for 14 days following test material removal.

No rats died during the observation period, and no clinical or pathological signs were observed. On the basis of these results, it was concluded that the acute lethal dermal dose to rats of DEGDB was demonstrated to be greater than 2000 mg/kg bodyweight.