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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1972
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: 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 results are reported clearly.

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)
Deviations:
yes
Remarks:
7 day observation period
GLP compliance:
no
Remarks:
pre-GLP
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
Lemongrass oil
IUPAC Name:
Lemongrass oil
Details on test material:
- Name of test material (as cited in study report): Lemongrass E.I.
- Physical state: Liquid
- Lot/batch No.: Confidential
- Other: Test material received from RIFM on January 21, 1972

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
not specified
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 1.9 - 2.3 kg

ENVIRONMENTAL CONDITIONS
No information available

IN-LIFE DATES: No information available

Administration / exposure

Type of coverage:
occlusive
Vehicle:
not specified
Details on dermal exposure:
TEST SITE
- Area of exposure: abdominal area (skin was abraded)
- Type of wrap if used: binders of rubber dam, gauze and adhesive tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw

VEHICLE
No information available
Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
10 rabbits
Control animals:
no
Details on study design:
- Duration of observation period following administration: 7 days
- Frequency of observations and weighing: daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, and skin irritation
Statistics:
not relevant

Results and discussion

Preliminary study:
not relevant
Effect levels
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: Mortality was observed in 1 animal
Mortality:
1/10
Clinical signs:
No effects observed
Body weight:
No significant changes in body weights were observed
Gross pathology:
No abnormalities were noted at necropsy
Other findings:
Skin irritation: Moderate erythema was noted in 7/10 animals, moderate signs of edema in 9/10 and moderate atonia in 2/10 animals

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Dermal application of Lemongrass oil in 10 New Zealand White rabbits at a dose of 2000 mg/kg body weight resulted in 1 death animal. Therefore, the LD50 was established exceeding 2000 mg/kg and Lemongrass oil does not need to be classified for acute dermal toxicity according to the criteria outlined in Annex I of 1272/2008/EC (CLP), under the conditions of this study.
Executive summary:

A single dose of 2000 mg/kg Lemongrass oil was applied dermally to the abraded abdominal skin of 10 New Zealand White rabbits. The treated skin site was covered with binders of rubber dam, gauze and adhesive tape for 24 hours. After 24 hours, the wrapping was removed and the rabbits were observed for mortality and toxicity for a period of 7 days.

Under the conditions of this study, dermal application of Lemongrass oil caused a mortality of 1/10 in New Zealand White rabbits at a dose of 2000 mg/kg body weight. Signs of skin irritation were observed as moderate erythema in 7/10 animals, moderate signs of edema in 9/10 and moderate atonia in 2/10 animals. In conclusion, the LD50 was established to be exceeding 2000 mg/kg and Lemongrass oil does not need to be classified for acute dermal toxicity according to the criteria outlined in Annex I of 1272/2008/EC (CLP), under the conditions of this study.

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