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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2004-12-06 to 2004-12-20
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2004
Report date:
2004

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
adopted 24 Feb, 1987
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Version / remarks:
Directive 92/69
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.1200 (Acute Dermal Toxicity)
Version / remarks:
EPA 712-C-98-192, August, 1998
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Bis(2-ethylhexyl) carbonate
EC Number:
238-925-9
EC Name:
Bis(2-ethylhexyl) carbonate
Cas Number:
14858-73-2
Molecular formula:
C17H34O3
IUPAC Name:
bis(2-ethylhexyl) carbonate
Test material form:
other: liquid

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Age at study initiation: no data
- Weight at study initiation: male 233 - 245 g, female 203 - 237 g
- Fasting period before study: none
- Housing: Macrolon cages on Altromin saw fiber bedding
- Diet: ad libitum, Altromin 1324 maintenance diet for rats and mice, totally-pathogen-free (TPF)
- Water: ad libitum, tap water (drinking water, municipal residue control, microbioI. controlled periodically)
- Acclimation period: Adequate acclimatization period


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 55 ± 10
- Air changes (per hr): l0
- Photoperiod (hrs dark / hrs light): Artificial light, sequence being 12 hours light, 12 hours dark

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: 10% of the total body surface, approximately 24 hours before the test, fur was removed from the dorsal area of the trunk by clipping.
- Type of wrap if used: The test item was applied to the patch first, and then applied to the skin. Test item was held in contact with the skin with a gauze-dressing and nonirritating tape and was fixed with an additional dressing in a suitable manner.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no washing mentioned
- Time after start of exposure: patch removal after 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw
- Concentration (if solution): applied undiluted

VEHICLE
- no vehicle used
Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
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:
-- The animals were weighed prior to application and once a week thereafter.
-- A careful clinical examination was made at least twice a day on the day of dosing and once a day thereafter. Cageside observations included changes in the skin and fur, eyes and mucous membranes. Also respiratory, circulatory, autonomic and central nervous systems and somatomotor activity and behaviour pattern were examined. Particular attention was directed to observations of tremor, convulsions, salivation, diarrhoea, lethargy, sleep and coma.
- Necropsy of survivors performed: yes
Statistics:
no

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Remarks on result:
other: approx. 100 % a.i; no animal died
Mortality:
0/10
Clinical signs:
other: No clinical signs of toxicity were observed throughout the observation period. The skin at the application site showed no changes.
Gross pathology:
Beside acute injection of blood vessels in the abdominal region, which is due to the euthanasia injection no special gross pathological changes were found in any animals.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: other: CLP, EU GHS (Regulation (EC) No 1272/2008)
Conclusions:
On the basis of the results obtained after a single dermal administration in rats, the dermal LD50 of Bis(2-ethylhexyl) carbonate was determined to be > 2000 mg/kg bw. No significant clinical signs, changes in body weight or gross patological findings were observed.
Executive summary:

In an acute dermal toxicity study performed as limit test according to the guidelines OECD 402, adopted 24 Feb. 1987, Directive 92/69 EU Method B.3 (Acute Toxicity (Dermal)) and OPPTS 870.1200, EPA 712-C-98-192, August 1998, 5 female and 5 male young adult Wistar rats were dermally exposed to Bis(2-ethylhexyl) carbonate (99 - 100 % a.i.) for 24 hours to 10% of body surface area at a dose of 2000 mg/kg bw. Animals then were observed for 14 days.

Dermal LD50 Males and Females >  2000 mg/kg bw

No mortality occured in this limit test.

No clinical signs of toxicity were observed throughout the observation period.

The skin at the application site showed no changes.

Weight gain of all animals was within the expected range.

No test substance related gross pathological changes were found in any animals.