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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:
weight of evidence
Study period:
1969
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
documentation insufficient for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1969
Report date:
1969

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Draize Technique
GLP compliance:
no
Remarks:
Study pre-dates introduction of GLP guidelines
Type of study:
Draize test
Justification for non-LLNA method:
LLNA not available at the time of testing.

Test material

Constituent 1
Chemical structure
Reference substance name:
2,6-dimethylheptan-2-ol
EC Number:
236-244-1
EC Name:
2,6-dimethylheptan-2-ol
Cas Number:
13254-34-7
Molecular formula:
C9H20O
IUPAC Name:
2,6-dimethylheptan-2-ol
impurity 1
Reference substance name:
Unknown impurities
Molecular formula:
not applicable
IUPAC Name:
Unknown impurities
Test material form:
liquid
Specific details on test material used for the study:
Giv 2-2356 Dimetol (2,6-Dimethylheptan-2-ol)

In vivo test system

Test animals

Species:
human
Sex:
male/female

Study design: in vivo (non-LLNA)

Details on study design:
2% solution by weight in dimethyl phthalate

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
2%
No. with + reactions:
0
Total no. in group:
53
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
2%
No. with + reactions:
0
Total no. in group:
53
Remarks on result:
no indication of skin sensitisation

Any other information on results incl. tables

Fifty three subject, 35 female and 18 male, of representative age groups concluded a full sensitization and challenge test study in accordance with the described Draize repeated insult technique. There were no reactions manifested by any one of these subjects in the challenge test to any one of the eight prepatations in the challenge test and there were no significant reactions of either an irritative or allergenic character by any of the individuals in response to any of these preparation during the sensitization phase of the study.

Minor adhesive tape reactions were recorded but not repeated during the challenge tests.

It is therefore concluded that the eight preparations studied in this investigation are not primary irritants in the concentrations employed and that in these concentrations they were not allergenic to any of the 53 subjects who completed the full study.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Fifty three subject, 35 female and 18 male, of representative age groups concluded a full sensitization and challenge test study in accordance with the described Draize repeated insult technique. There were no reactions manifested by any one of these subjects in the challenge test to any one of the eight prepatations in the challenge test and there were no significant reactions of either an irritative or allergenic character by any of the individuals in response to any of these preparation during the sensitization phase of the study.
Minor adhesive tape reactions were recorded but not repeated during the challenge tests.
It is therefore concluded that the eight preparations studied in this investigation are not primary irritants in the concentrations employed and that in these concentrations they were not allergenic to any of the 53 subjects who completed the full study.