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Administrative data

Description of key information

The single oral dosing of rats with 5 mL/kg of the test item caused no mortality or any visible toxic effects. As this dose level did not produce a toxic effect, a complete LD50 study was not performed.

The single dermal dosing of rabbits with 5 mL/kg bw of the test item caused no mortality or any visible toxic effects, except of mild erythema. As this dose level did not produce a toxic effect, a complete LD50 study was not performed.

Key value for chemical safety assessment

Acute toxicity: via oral route

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Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1972-1973
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions
Qualifier:
no guideline followed
Principles of method if other than guideline:
Normal, healthy rats of the Charles River strain, equally divided as to sex and weighing 200 to 300 grams, were used in this study. The animals were fasted for eighteen hours prior to dosing. The test material was fed as received. A rigid stomach tube was employed for the dosing.
Following the administration of the test material the animals were observed for fourteen days for signs of toxicity. Throughout the observation period the animals were housed in raised wire mesh cages in an air conditioned room. They were fed their regular diet of Lab Blox and water ad libitum.
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes
Specific details on test material used for the study:
Name: Hydroxycitronellol
Batch: E. O. A. # 72-128 / 5-25-72
Species:
rat
Strain:
other: Charles River
Sex:
male/female
Details on test animals or test system and environmental conditions:
Normal, healthy rats of the Charles River strain, equally divided as to sex and weighing 200 to 300 grams, were used in this study. The animals were fasted for eighteen hours prior to dosing. The test material was fed as received. A rigid stomach tube was employed for the dosing.
Following the administration of the test material the animals were observed for fourteen days for signs of toxicity. Throughout the observation period the animals were housed in raised wire mesh cages in an air conditioned room. They were fed their regular diet of Lab Blox and water ad libitum.
Route of administration:
oral: gavage
Vehicle:
not specified
Details on oral exposure:
not further specified
Doses:
5000 mg/kg
No. of animals per sex per dose:
5 m / 5 f
Control animals:
not specified
Details on study design:
The animals were fasted for eighteen hours prior to dosing. Following the administration of the test material the animals were observed for fourteen days for signs of toxicity.
Statistics:
not further specified
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 mL/kg bw
Based on:
test mat.
Remarks on result:
not determinable due to absence of adverse toxic effects
Mortality:
The dosing caused no mortality.
Clinical signs:
The dosing caused no adverse effects.
Body weight:
The dosing caused no adverse effects.
Gross pathology:
not further specified
Interpretation of results:
Category 5 based on GHS criteria
Conclusions:
The LD50 was greater as 5 mL/kg bw.
Executive summary:

The single oral dosing of rats with 5 mL/kg of the test item caused no mortality or any visible toxic effects. As this dose level did not produce a toxic effect, a complete LD50 study was not performed.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Acute toxicity: via inhalation route

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Reference
Endpoint:
acute toxicity: inhalation
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Justification for type of information:
Due to animal welfare a further experimental study with exposure of test animals via inhalation is not adequate as valid acute studies with oral and dermal dosing are available. Furthermore, inhalation is not considered to be a relevant pathway for potential human exposure to the test item.
Endpoint conclusion
Endpoint conclusion:
no study available

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:
1972-1973
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions
Qualifier:
no guideline followed
Principles of method if other than guideline:
Four normal, healthy, albino rabbits, weighing 2 to 3. 5 kilo, were used in this study. The animals had been acclimated to laboratory conditions for at least two weeks prior to being placed on test. Prior to placing the animals on test their backs were clipped free of all hair with small animal clippers. The backs were further prepared by making epidermal abrasions every two to three centimeters, longitudinally, over the clipped area of exposure. The abrasions were sufficiently depp so that they penetrated the stratum corneum but not the dermis, so that no bleeding occurred.
The test material, at a level of 5 ml. per kilo, was applied to the clipped intact and abraded skin areas. These areas were covered with a rubber sleeve or dam which fit snuggly around each animal. The animals were then placed in a multiple animal holder and held there for a twenty-four hour period. During this time each test animal was allowed its daily ration of rabbit pellets and water.
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes
Specific details on test material used for the study:
Name: Hydroxycitronellol
Batch: E. O. A. # 72-128 / 5-25-72
Species:
rabbit
Strain:
other: Albino
Sex:
not specified
Details on test animals or test system and environmental conditions:
Four normal, healthy, albino rabbits, weighing 2 to 3. 5 kilo, were used in this study. The animals had been acclimated to laboratory conditions for at least two weeks prior to being placed on test.
Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Duration of exposure:
24
Doses:
5 mL/kg bw
No. of animals per sex per dose:
3
Control animals:
no
Details on study design:
Following the twenty-four hour exposure period the rubber sleeves were removed from the test animals and skin reactions recorded.
Each animal was thoroughly wiped down and returned to its own metabolism cage to be observed for a fourteen day period.
Statistics:
not further specified
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 mL/kg bw
Based on:
test mat.
Remarks on result:
not determinable due to absence of adverse toxic effects
Mortality:
No deaths occurred at a level of 5 ml. per kilo.
Clinical signs:
All the animals showed a mild erythema on both the intact and abraded areas.
Body weight:
The dosing caused no adverse effects.
Gross pathology:
not further specified
Interpretation of results:
Category 5 based on GHS criteria
Conclusions:
The LD50 was greater as 5 mL/kg bw.
Executive summary:

The single dermal dosing of rabbits with 5 mL/kg bw of the test item caused no mortality or any visible toxic effects, except of mild erythema. As this dose level did not produce a toxic effect, a complete LD50 study was not performed.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Additional information

Justification for classification or non-classification

The single oral dosing of rats with 5 mL/kg of the test item caused no mortality or any visible toxic effects. As this dose level did not produce a toxic effect, a complete LD50 study was not performed.

The single dermal dosing of rabbits with 5 mL/kg bw of the test item caused no mortality or any visible toxic effects, except of mild erythema. As this dose level did not produce a toxic effect, a complete LD50 study was not performed.