Registration Dossier

Administrative data

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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1973
Report date:
1973

Materials and methods

Test guideline
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

Test material

Constituent 1
Chemical structure
Reference substance name:
3,7-dimethyloctane-1,7-diol
EC Number:
203-517-1
EC Name:
3,7-dimethyloctane-1,7-diol
Cas Number:
107-74-4
Molecular formula:
C10H22O2
IUPAC Name:
3,7-dimethyloctane-1,7-diol
Test material form:
liquid
Specific details on test material used for the study:
Name: Hydroxycitronellol
Batch: E. O. A. # 72-128 / 5-25-72

Test animals

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.

Administration / exposure

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

Results and discussion

Effect levels
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

Applicant's summary and conclusion

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.