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Toxicological information

Acute Toxicity: dermal

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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 guidelineopen allclose all
Qualifier:
according to
Guideline:
EPA OTS 798.1100 (Acute Dermal Toxicity)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Deviations:
no
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
Qualifier:
according to
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

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
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
- Analytical purity: Diethylene glycol dibenzoate - 89.9% (w/w)
- Impurities (identity and concentrations):
Diethylene glycol monobenzoate - 5.85% (w/w)
Dipropylene glycol dibenzoate - 1.50% (w/w)
Ethylene glycol dibenzoate - 0.19% (w/w)
Triethylene glycol dibenzoate - 0.15% (w/w)
Unidentified component 1 - 0.10% (w/w)
Unidentified component 2 - 0.10% (w/w)
Unidentified component 3 - 0.54% (w/w)
- Lot/batch No.: 56625030
- Expiration date of the lot/batch: 19 May 1998
- Storage condition of test material: Room temperature.

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals 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:
There were no signs of systemic reaction to treatment observed throughout the study.
Body weight:
A slightly low bodyweight gain was recorded for one female on Day 15. All other rats were considered to have achieved satisfactory bodyweight gains throughout the study.
Gross pathology:
No abnormalities were recorded at the macroscopic examination on Day 15.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information According to Directive 67/548/EEC. Criteria used for interpretation of results: EU
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.