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The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
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:
publication
Title:
Development and Validation of an Alternative Dermal Sensitization Test: The Mouse Ear Swelling Test (MEST)
Author:
Gad SC, Dunn BJ, Dobbs DW, Reilly C, Walsh RD
Year:
1986
Bibliographic source:
Toxicology and Applied Pharmacology 84: 93-114

Materials and methods

Principles of method if other than guideline:
Mouse ear swelling test
GLP compliance:
not specified
Type of study:
mouse ear swelling test
Justification for non-LLNA method:
Existing study.

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

In vivo test system

Test animals

Species:
mouse
Strain:
CF-1
Sex:
female

Study design: in vivo (non-LLNA)

Induction
Route:
epicutaneous, open
Vehicle:
other: Ethanol 95%
Concentration / amount:
50%
Challenge
No.:
#1
Route:
epicutaneous, open
Vehicle:
other: Ethanol 95%
Concentration / amount:
50%
No. of animals per dose:
10-15 (control 5-10)
Details on study design:
On the first day of the study the animals abdomens were clipped and tape stripped and two intradermal injections totaling 0.05 ml of Freund's Complete Adjuvant were administered.
A 50% solution in 95% ETOH, 100 μl, was applied to the shaved area on the first day and the following 3 days, with the skin being tape stripped before each application.
After a 7 day nontreatment period, a topical application of 20 μl of a 50% solution in 95% ETOH, was made to the left ear of the mouse while the right ear received 20 μl of the vehicle alone.
The ear thickness was measured 24 and 48 h after the challenge application.

Results and discussion

In vivo (non-LLNA)

Results
Reading:
1st reading
Group:
test chemical
Dose level:
50%
No. with + reactions:
2
Total no. in group:
10
Clinical observations:
The percentage swelling was reported as 114%, with a value of 100% indicating no swelling.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
According to the results of MEST in mice the substance is not to be classified with only 20% of sensitised animals and the swelling is below the threshold of 20% (here: 14%)
Executive summary:

According to the results of MEST in mice the substance is not to be classified with only 20% of sensitised animals and the swelling is below the threshold of 20% (here: 14%)