Cinnamomum cassia, ext.

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

May 1972

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study was conducted according to a method similar to OECD 402, but was performed pre-GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1972

Report date:

1972

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

no

Remarks:

pre-GLP

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Cinnamomum cassia, ext.

EC Number:

284-635-0

EC Name:

Cinnamomum cassia, ext.

Cas Number:

84961-46-6

IUPAC Name:

(2E)-3-(2-methoxyphenyl)prop-2-enal; (2E)-3-phenylprop-2-en-1-yl acetate; (2E)-3-phenylprop-2-enal

Constituent 2

Reference substance name:

RIFM-72-4-79C

IUPAC Name:

RIFM-72-4-79C

Details on test material:

- Name of test material (as cited in study report): RIFM-72-4-79C, Cassia Oil
- Physical state: liquid (clear yellow)

Test animals

Species:

rabbit

Strain:

not specified

Sex:

not specified

Details on test animals or test system and environmental conditions:

No data

Administration / exposure

Type of coverage:

not specified

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.16, 0.316, 0.63, 1.26 and 2.5 ml/kg
- Constant volume or concentration used: yes

Duration of exposure:

Single application

Doses:

168, 332, 600, 1323 and 2625 mg/kg (assuming density of 1.05 g/ml)

No. of animals per sex per dose:

2 animals per dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days

Statistics:

Mortality data were evaluated according to the Thompson Moving Average Method (Carrol S. Weil, Biometrics Vol.8 No.3 pp. 249-263, September 1952))

Results and discussion

Preliminary study:

Not applicable

Effect levels

Sex:

not specified

Dose descriptor:

LD50

Effect level:

332 mg/kg bw

Based on:

test mat.

95% CL:

221 - 504

Remarks on result:

other: One out of two animals died on day 6

Mortality:

At lowest dosage level, no animals died. At second dosage level, 332 mg/kg bw, one animal died on day 6. At dosage level 662 mg/kg one animal died on day 1 and one on day 3. At the two highest dosage levels all animals died on day 1.

Clinical signs:

other: No data

Gross pathology:

No data

Applicant's summary and conclusion

Interpretation of results:

Category 3 based on GHS criteria

Remarks:

in accordance with the criteria outlined in Annex I of the CLP Regulation (1272/2008/EC)

Conclusions:

Under the conditions of this study, an LD50 of 332 mg/kg bw/day was determined for Cassia oil. Therefore, this substance is considered toxic in contact with skin and should be classified as such according to the criteria outlined in Annex I of CLP (Acute Tox. 3 / H311).

Executive summary:

Ten albino rabbits were tested for acute dermal toxicity, according to a method similar to OECD 402. Five doses of Cassia oil were tested (168, 332, 600, 1323, 2625 mg/kg bw) using 2 animals per dose.

At the lowest dose no animals died. At the dose of 0.332 mg/kg bw 1 of two animals died and at the higher doses all animals died. The LD50 for Cassia oil was determined to be 332 mg/kg bw under the conditions of this study.