Orange, sweet, ext.

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1973

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

Test was conducted according to methods similar to OECD guideline 402 (limit test) and was performed pre-GLP. A concise description of the protocol is available and a table with results is included.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1973

Report date:

1973

Materials and methods

Test guideline

Test guideline 1

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: Federal Hazardous Substance Act (FHSA)

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Orange, sweet, ext.

EC Number:

232-433-8

EC Name:

Orange, sweet, ext.

Cas Number:

8028-48-6

Molecular formula:

This reference substance is a UVCB of the NCS type. It is a complex mixture of compounds and therefore molecular formula, molcular weight, and structural formula cannot be given.

IUPAC Name:

Essential oil of orange obtained from the peel of Citrus sinensis (Rutaceae) by expression and/or distillation, including cold pressed, distilled, terpenes and essence qualities

Constituent 2

Reference substance name:

Oil orange calif. cold pressed

IUPAC Name:

Oil orange calif. cold pressed

Constituent 3

Reference substance name:

Orange oil

IUPAC Name:

Orange oil

Details on test material:

- Name of test material (as cited in study report): Oil orange calif. cold pressed (orange oil)- Physical state: Liquid- Purity: No data- Lot/batch No.: Confidential information

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: approx. 2 kg
- Housing: 2/cage
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum

ENVIRONMENTAL CONDITIONS
Temperature controlled room

Administration / exposure

Type of coverage:

occlusive

Vehicle:

not specified

Details on dermal exposure:

TEST SITE
- Area of exposure: Adbominal area (skin was abraded)
- Type of wrap if used: 2 single layers of gauze and impervious material

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

Duration of exposure:

24 hours

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

10 rabbits (female)

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Daily
- Necropsy of survivors performed: no
- Other examinations performed: clinical signs and skin irritation

Statistics:

Not relevant

Results and discussion

Preliminary study:

Not relevant

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: Moderate redness was noted in 10 out of 10 animals, slight edema in 3/10 and moderate edema in 5/10 animals

Mortality:

No mortality observed

Clinical signs:

other: No effects observed

Gross pathology:

Not performed

Other findings:

Skin irritation: moderate redness was noted in 10 out of 10 animals, slight edema in 3/10 and moderate edema in 5/10 animals

Applicant's summary and conclusion

Interpretation of results:

other:

Remarks:

CLP criteria not met

Conclusions:

Under the conditions of this study, dermal application of orange oil did not induce any mortality at a dose of 5000 mg/kg. Therefore, a LD50 of >5000 mg/kg was established and the substance does not need to be classified for acute dermal toxicity according to the criteria outlined in Annex I of 1272/2008/EC (CLP) and Annex VI of 67/548/EEC (DSD).

Executive summary:

A single dose of 5000 mg/kg orange oil was applied dermally to the abraded abdominal skin of 10 female New Zealand White rabbits. Skin was covered with 2 single layers of gauze and wrapped with impervious material for 24 hours. After 24 hours the wrapping was removed and the rabbits were cleansed. The rabbits were observed for 14 days thereafter for mortality and symptomatology (skin irritation).

Under the conditions of this study, dermal application of orange oil did not induce any mortality or clinical signs at a dose of 5000 mg/kg. Skin irritation was observed, as moderate redness was noted in 10 out of 10 animals, slight edema in 3/10 and moderate edema in 5/10 animals. In conclusion, a LD50 of >5000 mg/kg was established and the substance does not need to be classified for acute dermal toxicity according to the criteria outlined in Annex I of 1272/2008/EC (CLP) and Annex VI of 67/548/EEC (DSD).