Cymbopogon winterianus, ext.

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

09 September 2015 to 30 September 2015

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP study, performed according to the OECD Guideline 402.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2015

Report date:

2015

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

yes

Remarks:

Initially, 1 animal/sex was given a single dose of 2000 mg/kg body weight. Based on the result, an additionalgroup of 8 animals was treated accordingly. This deviation does not compromise the result of the study.

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Citronella oil (Cymbopogon winterianus, ext.)

IUPAC Name:

Citronella oil (Cymbopogon winterianus, ext.)

Constituent 2

Reference substance name:

91771-61-8

Cas Number:

91771-61-8

IUPAC Name:

91771-61-8

Test material form:

other: liquid

Details on test material:

- Name of test material (as cited in study report): Citronella oil (Cymbopogon winterianus, ext.)
- Physical state: liquid (pale yellow)
- Analytical purity: 100%
-Storage conditions: approximately 4 °C in the dark

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Envigo RMS (UK) Limited, Oxon, UK
- Age at study initiation: 8 to 12 weeks
- Weight at study initiation: at least 200 g
- Fasting period before study: overnight fast before dosing and for 3-4 hours after dosing
- Housing: indivudually during dosing and till 24 h post-treatment, in groups up to 4 animals of same sex rest of the experiment, suspended solid-floor polypropylene cages furnished with woodflakes
- Diet: ad libitum, 2014C Teklad Global Rodent diet
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25
- Humidity (%): 30 to 70
- Air changes (per hr): at least 15
- Photoperiod (hrs dark / hrs light): 12

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure, % coverage: 10% of the total body surface area
- Type of wrap if used: semi-occlusive self-adhesive bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): cotton wool moistened with arachis oil BP
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2.26 mL/kg
- Constant volume or concentration used: yes

VEHICLE no vehicle used

Duration of exposure:

24 h

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

not required

Details on study design:

Initially, 2 animals (1 male, 1 female) were given a single dermal application of the test item at a dose level of 2000 mg/kg body weight. Based on the result, an additionalgroup of 8 animals was treated accordingly.
- Duration of observation period following administration: 14 days
- Frequency of clinical observations : 30 min, 1, 2, & 4 h after dosing and then daily for up to 14 days
- Body weight recording: at Day 0 (after dosing), Day 7 and 14
- Morbidity/mortality: twice daily
- Necropsy performed: yes, external examination and opening of the abdominal and thoracic cavities
- Other examinations performed: yes, irritation scoring assigned once per day for the whole observation period

Statistics:

Not applicable

Results and discussion

Preliminary study:

No signs of systemic toxicity observed at any of the two animals treated during the initial test.

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality was detected

Clinical signs:

other: No signs of toxicity observed at any the two animals treated

Gross pathology:

No abnormalities seen

Other findings:

- Other observations: no signs of dermal irritation

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The dermal LD50 of Citronella oil (Cymbopogon winterianus, ext.) was estimated to be higher than 2000 mg/kg bw, under the conditions of this test and hence, the test substance is practically non toxic.

Executive summary:

In an acute dermal toxicity study, performed according to OECD 402, male and female Wistar rats were administered with a single dose of unchanged Citronella oil (Cymbopogon winterianus, ext.), for 24 h kept in place with a semi- occlusive dressing. An initial test was performed with one male and one female animal. The results lead to an additional group of four animals/sex treated with a single same dose of 2000 mg/kg bw, followed by a 14-day observation period. Mortality, clinical signs of toxicity and body weights were recorded. Irritation scorings were given. Necropsy was performed in all animals.

Treatment with the test item did not result in any deaths, clinical signs of toxicity or macroscopical abnormalitites. Transient body weight losses were recorded in two animals, but were deemed acceptable variations for the species tested. The dermal LD50 of the test substance was established to be higher than 2000 mg/kg bw, under the conditions of this test. The test shall not be classified for acute oral toxicity, as set down by the CLP 1272/2008/EC criteria.