Registration Dossier

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 guidelineopen allclose all
Qualifier:
according to
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.
Qualifier:
according to
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
GLP compliance:
yes (incl. certificate)
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
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 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:
No signs of toxicity observed at any the two animals treated
Body weight:
Slight body weight loss was recorded during the 1st week, and decreased body weight gain during the 2nd week, in one male and one female animal. The weight loss was considered to be within acceptable limits for the species.
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.