Mandarin orange, ext.

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1974

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Test was conducted according to methods similar to OECD 401 (limit test) and was performed pre-GLP. A concise description of the protocol is available and results are acceptable as basic data.

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1974

Report date:

1974

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

other: Federal Hazardous Substance Act

Deviations:

not specified

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

not specified

Principles of method if other than guideline:

not applicable

GLP compliance:

no

Remarks:

pre-GLP

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Mandarin oil

IUPAC Name:

Mandarin oil

Details on test material:

- Name of test material (as cited in study report): Mandarin italian oil
- Lot/batch No.: confidential

Test animals

Species:

rabbit

Strain:

not specified

Sex:

not specified

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 2.0 - 3.0 kg (in general)
- Housing: 2 per cage in suspended wire mesh cages. Bedding was placed beneath the cages.
- Diet: Fresh Purina Rabbit Chow (Diet #53-21) ad libitum
- Water: ad libitum
- Acclimation period: at least one week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): controlled

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: abdomen
- % coverage: 10%
- Type of wrap if used: gauze patch, torsi wrapped with plastic and secured with tape.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): test site was wiped.
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied: 5000 mg/kg bw

Duration of exposure:

24 hours

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

7 animals/dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: The test sites were scored for dermal irritation at 24 hours post dose and on Days 7 and 14 using numerical Draize scale.
- Frequency of observations and weighing: The animals were observed daily for 14 days for mortality, toxicity and pharmacological effects.

- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: clinical signs were described. Body weights were recorded pretest and at termination in the survivors. all animals were examined for gross pathology.

Statistics:

The LD50 and 95% confidence intervals were calculated (if possible).

Results and discussion

Preliminary study:

No animals died at the initial dose of 5.0 g/kg bw.

Effect levels

Sex:

not specified

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

0/7

Clinical signs:

other: Slight redness in 4 out of 7 animals. Slight edema in 3 out of 7 animals.

Gross pathology:

no data

Other findings:

no data

Any other information on results incl. tables

Distribution of Mortality:

Observation Day	1	2	3	4	5	6	7	8	9	10	11	12	13	14
No. of Animals	0	0	0	0	0	0	0	0	0	0	0	0	0	0

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The dermal LD50 in rabbits was > 5000 mg/kg bw under the conditions of this test. The substance does not have to be classified according to the EU classification criteria outlined in 67/548/EEC and 1282/2008/EC.

Executive summary:

An acute dermal toxicity study was conducted with Mandarin oil. A single 24 -hour application of the test material (5000 mg/kg bw) was applied to the clipped abdominal skin of 7 rabbits weighing 2.0 -3.0 kg. The animals were wrapped with a gauze patch and plastic, secured with tape. Following exposure, the binders were removed and daily observations made for mortality, toxicity and pharmacological effects for a period of 14 days. No animals died during the course of the study. The acute dermal LD50 for the test material as indicated by the data in this stuy is > 5000 mg/kg bw when applied to the skin of albino rabbits. Based on these results and according to the EU criteria outlined in 1272/2008/EC and 67/458/EEC, Mandarin oil does not need to be classified as acute toxic to the skin.