Registration Dossier

Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1972-1973
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

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

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
not specified

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

Test animals

Species:
rabbit
Strain:
other: albino
Details on test animals or test system and environmental conditions:
Four normal, healthy, albino rabbits, weighing 2 - 3.5 kg, 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 cm, longitudinally, over the clipped area of exposure.
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.
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.

Test system

Type of coverage:
occlusive
Preparation of test site:
other: intact and abraded skin
Vehicle:
not specified
Controls:
not specified
Amount / concentration applied:
5 mL/kg
Duration of treatment / exposure:
24 h
Observation period:
up to 14 days
Number of animals:
4
Details on study design:
Single application of 5 mL/kg onto intact and abraded skin, occlusive dressing over 24 hrs, readings at patch removal

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
not specified
Irritation parameter:
edema score
Basis:
mean
Time point:
24 h
Score:
0
Max. score:
4
Irritation parameter:
other: eschar score
Basis:
mean
Time point:
24 h
Score:
0
Max. score:
4

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
In this study with rabbits, the dermal occlusive application of 5 mL test item/kg bw over 24 hours onto intact and abraded skin caused only very mild erythema.
Executive summary:

In this study with rabbits, the dermal occlusive application of 5 mL test item/kg bw over 24 hours onto intact and abraded skin caused only very mild erythema.