Extract obtained from powder of Theobroma cacao (Malvaceae) by co-extraction with ethanol and propylene glycol

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Well-conducted study, available as unpublished report, minor restrictions in design and reporting, but otherwise adequate for assessment. Proof of the identity of the substance used in a study is the responsibility of the data owner of the study (internal company reference code 15537).

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1982

Report date:

1982

Materials and methods

Principles of method if other than guideline:

The test substance was administered at dose level 2000 mg/kg bw to the clipped skin of 10 rabbits (5 non-abraded, 5 abraded) for 24 hr under occlusive conditions. At 24 hours, patches were removed and the site washed. Animals were observed for 14 days for signs of mortality, toxicity and pharmacological effects. Gross pathology was performed on animals which died during the study

GLP compliance:

no

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Propane-1,2-diol

EC Number:

200-338-0

EC Name:

Propane-1,2-diol

Cas Number:

57-55-6

Molecular formula:

C3H8O2

IUPAC Name:

propylene glycol

Test animals

Species:

rabbit

Strain:

other: albino

Sex:

not specified

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Ace Animals
- Weight at study initiation: 2.1-2.7 kg
- Housing: 2/cage in suspended wire mesh cages
- Diet: fresh Purina Rabbit Chow (Diet #53-21), ad libitum
- Water: ad libitum
- Acclimation period: at least 1 week


ENVIRONMENTAL CONDITIONS
- Temperature (°C):
- Humidity (%):
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light):

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: ca. 10% of the body surface
- % coverage: 100
- Type of wrap if used: gauze patch; the torso was further wrapped with plastic which was secured with tape


REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 24 hr

Duration of exposure:

24 hr

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

10/dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: animals were observed daily for 14 days for mortality, toxicity and pharmacological effects. Body weights were recorded pretest and at termination in the survivors.
- Necropsy of survivors performed: no
- Other examinations performed: the test sites were scored for dermal irritation on days 1, 7 and 14 using the numerical Draize scale.

Results and discussion

Effect levels

Sex:

not specified

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

There were no mortalities.

Clinical signs:

other: Lethargy, diarrhea, few feces and/or ptosis were noted in isolated instanses.

Other findings:

Dermal responses, generally slight on day 1, were minimal on day 7 and absent on day 14.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Executive summary:

the LC50 is >2000mg/kg bw in an acute dermal toxicity in rabbit.