2-ethylhexyl chloroformate

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

secondary literature

Data source

Reference

Reference 1

Reference Type:

review article or handbook

Title:

RIFM Database, Synopis Report, 2-Ethyl-1-hexanol

Year:

2020

Reference 2

Reference Type:

publication

Title:

RIFM fragrance ingredient safety assessment, 2-ethyl-1-hexanol, CAS registry number 104-76-7

Author:

Api A.M. et al.

Year:

2016

Bibliographic source:

Food and Chemical Toxicology, 97, S147-S156

Materials and methods

Type of sensitisation studied:

skin

Study type:

study with volunteers

Principles of method if other than guideline:

Human skin sensitization test using the maximization method of Kligman (ref.2)

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

2-ethylhexan-1-ol

EC Number:

203-234-3

EC Name:

2-ethylhexan-1-ol

Cas Number:

104-76-7

Molecular formula:

C8H18O

IUPAC Name:

2-ethylhexan-1-ol

Details on test material:

- Name of test material (as cited in study report): 2 ethyl hexanol
- no further information on test substance

Method

Type of population:

other: healthy adult volunteers

Subjects:

29 volunteers completed the study

Controls:

not required

Route of administration:

dermal

Details on study design:

Test materials were applied under occlusion to the same site on the volar forearms of all subjects for 5 alternate day 48 hour periods. Patch sites were pre-tested for 24 hours with 5% aqueous sodium lauryl sulfate (SLS) under occlusion for the initial patch only. Following a 10-14 day rest period, challenge patches of all materials were applied under occlusion to fresh sites for 48 hours. Challenge applications were preceded by 30 minute applications of 5% aqueous SLS under occlusion on the left side of the back whereas the test materials were applied without SLS treatment on the right side. Additional SLS controls were placed on the left and petrolatum on the right and labeled site 5. Vehicle was petrolatum.

Results and discussion

Results of examinations:

2-Ethylhexanol did not produce any reactions that were considered irritant or allergic in the 29 human subjects tested. Under the conditions of the test used, 2-ethanol was not sensitizing.
Dose: 4% showed no effects.

Applicant's summary and conclusion

Conclusions:

2-Ethylhexanol did not produce any reactions that were considered irritant or allergic in the 29 human subjects tested. Under the conditions of the test used, 2-ethanol was not sensitizing.

Executive summary:

A human maximization study was conducted on 29 healthy subjects. Test materials were applied under occlusion to the same site on the volar forearms of all subjects for 5 alternate day 48 hour periods. Patch sites were pre-tested for 24 hours with 5% aqueous sodium lauryl sulfate (SLS) under occlusion for the initial patch only. Following a 10-14 day rest period, challenge patches of all materials were applied under occlusion to fresh sites for 48 hours. Challenge applications were preceded by 30 minute applications of 5% aqueous SLS under occlusion on the left side of the back whereas the test materials were applied without SLS treatment on the right side. Additional SLS controls were placed on the left and petrolatum on the right and labeled site 5. Vehicle was petrolatum. Dose of 4% showed no effects.