Registration Dossier

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-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1974
Report Date:
1974

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
other: Federal Hazardous Substance Act
Deviations:
not specified
Qualifier:
equivalent or similar to
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

Reference
Name:
Unnamed
Type:
Constituent
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 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:
Slight redness in 4 out of 7 animals.
Slight edema in 3 out of 7 animals.
Body weight:
no data
Gross pathology:
no data
Other findings:
no data

Any other information on results incl. tables

Distribution of Mortality:

 Observation Day  1 10  11  12 13  14 
  No. of Animals

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.