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Administrative data

Description of key information

Acute oral toxicity: LD50 > 4.367 g/kg bw (5 ml/kg bw) (standard acute method, limit test; similar to OECD 401)
Acute dermal toxicity: LD50 > 4.367 g/kg bw (5 ml/kg bw) (standard acute method, limit test; similar to OECD 402)

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
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.
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
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
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)
Preliminary study:
Not relevant
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.
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).

Endpoint conclusion
Dose descriptor:
LD50
Value:
4 367 mg/kg bw

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
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 402 (limit test) and was performed pre-GLP. A concise description of the protocol is available and results are reported clearly.
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
no
Remarks:
pre-GLP
Test type:
standard acute method
Limit test:
yes
Species:
rabbit
Strain:
New Zealand White
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: 2.5 to 3.0 kg.
- Housing: individually
- Diet: commercial diet ad libitum
- Water: ad libitum

ENVIRONMENTAL CONDITIONS: no data
Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: approx. 240 cm2
- % coverage: about 10% of body surface
- Type of wrap if used: the test material was delivered under a rubber sleeve by using a hypodermic syringe; then the sleeve was covered with Webril padding. The rabbit was fitted with a collar to prevent the removal of the wrappings.

REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: after 24 hours later the binders were removed

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 5 ml/kg = 4.367 g/kg bw
Duration of exposure:
24 hours
Doses:
5 ml/kg = 4.367 g/kg bw
No. of animals per sex per dose:
6 animals/dose
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily for 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, dermal reactions
Statistics:
Not relevant
Preliminary study:
Not relevant
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 4 367 mg/kg bw
Based on:
test mat.
Remarks on result:
other: 5.0 ml/kg
Mortality:
1 out of 6 rabbits died on day 3
Clinical signs:
No toxic signs observed
Body weight:
No data available
Gross pathology:
The one rabbit that died showed hemorrhagic lungs. There was no tissue damage observed in rabbits killed at the termination of the study.
Other findings:
Dermal reactions:
Edema*: 1-4 (3/6)
Erythema*: 1-4 (6/6)
Discoloration: + (4/6)
Scaling: + (5/6)
Necrosis: + (5/6)
Eschar Formation: + (5/6)

* = According to Draize's scoring method
+ = Presence
Numbers in parentheses indicate number of animals that showed reactions
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The dermal LD50 value of lime oil in rabbits was established as exceeding 4.367 g/kg body weight (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 dermally to 6 male/female New Zealand White rabbits. The test was conducted according to methods similar to OECD 402 (limit test) and was performed pre-GLP. The animals were observed for 14 days. One animal out of 6 died on day 3. No symptoms were noted. Dermal reactions, characterized by erythema and edema of varied degrees, were produced by lime oil. Other dermal reactions such as discoloration, scaling, necrosis, and eschar formation also occurred in most of the animals. The one rabbit that died showed hemorrhagic lungs. There was no tissue damage observed in rabbits killed at the termination of the study. The dermal LD50 value of lime oil in rabbits 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).

Endpoint conclusion
Dose descriptor:
LD50
Value:
4 367 mg/kg bw

Additional information

Acute oral toxicity was tested in a standard acute limit test, in which a single dose of lime oil (5 ml/kg bw = 4.367 g/kg bw) was administered orally to 10 rats. No mortality was observed. The animals were observed up to 14 days after application. The oral LD50 was established to be > 4.367 g/kg bw (5.0 ml/kg bw).

Acute dermal toxicity was also tested in a standard acute limit test, in which 6 male/female New Zealand White rabbits were exposed to a single dose of lime oil (5.0 ml/kg bw = 4.367 g/kg bw) dermally. One animal out of 6 died on day 3. The animals were observed up to 14 days after application. The dermal LD50 was established to be > 4.367 g/kg bw (5.0 ml/kg bw).

Justification for classification or non-classification

Based on the available information, lime oil has been shown to be of low acute toxicity when applied via the oral and dermal route. Therefore, the substance lime oil does not need to be classified for acute toxicity according to the criteria outlined in Annex I of 1272/2008/EC (CLP/EU-GHS) and Annex VI of 67/548/EEC.