Dioctyl carbonate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1999-09-22 to 1999-10-07

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1999

Report date:

1999

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

February 1987

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

January 1997

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

Test animals:
- Source: Tierzucht Schönwalde GmbH, D-16352 Schönwalde, Germany
- Weight at study initiation: 206 - 240 g
- Fasting period before study: no
- Housing: transparent polycarbonate cages (macrolone type ID, floor area 810 sq. cm) with two or three in each cage, males and females separated. The cages were cleaned and the bedding changed at least twice a week.
- Diet: pelleted complete rodent diet "Altrornin 1314" from Altromin GmbH, D-32791 Lage, Lippe, was available ad libitum
- Water: domestic quality drinking water acidified with hydrochloric acid to pH 2.5 in order to prevent microbial growth
- Acclimation period: 7 days

Environmental conditions:
- Temperature: 21 +/- 3 °C
- Humidity: 55 % +/-15 %
- Air changes: 10 tirnes per hour
- Photoperiod: 12 hours light and 12 hours darkness, light from 6 am to 6 pm

In-life dates:From 1999-09-22 to 1999-10-07

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

Test site:
- Area of exposure: 5 x 6 cm
- Type of wrap if used: 4-layer gauze pack fixed with Micropore tap

Removal of test substance after 24 h:
- Washing: lukewarm water
- Time after start of exposure: 24 h

Test material:
- Amount applied: 5000 mg/kg bw

Vehicle: none

Duration of exposure:

24 h

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

5 males/5 females per dose

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observation: 1, 3 and 6 hours after dosing and thereafter daily for a period of 14 consecutive days; weighing: on day 0, 7 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs

Statistics:

NA

Results and discussion

Preliminary study:

Prior to the main study a pilot study was performed using one male rat given 2000 mg/kg bw and one female rat given 5000 mglkg bw. Very slight signs of toxicity were observed in these rats. On the basis of the results of the pilot study it was decided to carry out the main study with one group consisting of five male and five female rats given a dose of 5000 mg/kg bw.

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

Neither male nor female rats died at this dose level nor did they show marked signs of toxicity during the study period.

Clinical signs:

other: Male: One hour after the application all animals showed piloerection. All further observations after 3 and 6 hours and from day 1 until the end ofthe observation period revealed no abnormalities. Female: One hour after the application all animals showed

Gross pathology:

The post martern inspection revealed no abnormalities.

Other findings:

None

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information