2,6-dimethylheptan-2-ol

Skin sensitisation

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

Test material information

Constituent 1

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)

Results

Results 1

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

Results 2

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.