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Diss Factsheets

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
July 1971
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 401 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:
1971
Report date:
1971

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
no
Remarks:
pre-GLP
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
Lime Oil
IUPAC Name:
Lime Oil
Details on test material:
- Name of test material (as cited in study report): Lime oil
- Physical state: Liquid
- Lot/batch No.: Confidential information

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: no data
- Age at study initiation: no data
- Weight at study initiation: 150 to 300 grams
- Fasting period before study: overnight
- Housing: individually
- Diet: commercial diet ad libitum
- Water: ad libitum

ENVIRONMENTAL CONDITIONS: no data

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 50% (w/v or v/v)
Doses:
5 ml/kg = 4.367 g/kg bw
No. of animals per sex per dose:
10 animals/dose
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: toxic signs and mortality were recorded immediately following dosing and once daily thereafter for 14 days.
- Necropsy of survivors performed: yes
Statistics:
The LD50 value was calculated according to Horn's method (Horn, H. J., Biometrics, 12, 311-322, 1956)

Results and discussion

Preliminary study:
Not relevant
Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 4 367 mg/kg bw
Remarks on result:
other: (5 ml/kg bw)
Mortality:
No mortality observed
Clinical signs:
Bloody crust nose, salivation, lacrimation, and depression
Body weight:
No data available
Gross pathology:
At termination, one animal had enlarged right kidney; one had pale kidneys.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The oral LD50 value of lime oil in rats was established as exceeding 4.367 g/kg bw (5.0 ml/kg bw), under the conditions of this study. The substance therefore does not need to be classified according to the classification criteria outlined in Annex VI of 67/548/EEC (DSD) and Annex I of 1272/2008/EC (CLP).
Executive summary:

A single 5 ml/kg bw (4.367 g/kg bw) dose of lime oil was administered orally to 10 rats. The test was conducted according to methods similar to OECD 401 and was performed pre-GLP. Toxic signs and mortality were recorded immediately following dosing and once daily thereafter for 14 days. Necropsy was performed on survivors.

No mortality was observed. Toxic signs included bloody crust nose, salivation, lacrimation, and depression. At termination, one animal had enlarged right kidney; one had pale kidneys. The oral LD50 value of lime oil in rats was established as exceeding 4.367 g/kg bw (5.0 ml/kg bw), under the conditions of this study. The substance therefore does not have to be classified according to the classification criteria outlined in Annex VI of 67/548/EEC (DSD) and Annex I of 1272/2008/EC (CLP).