Dodecan-1-ol, ethoxylated

Skin sensitisation

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:

data from handbook or collection of data

Justification for type of information:

Data is from peer reviewed journal.

Data source

Reference

Reference Type:

publication

Title:

The toxicology and biological properties of test chemical

Author:

D.A.Berberian et al.,

Year:

1965

Bibliographic source:

Toxicology and Applied Pharmacology.; 1965

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: as mentioned below

Principles of method if other than guideline:

The test material was tested as an aqueous solution and as an ingredient of an aerosol contraceptive formulation containing 20% test chemical to determine if sensitization is produced by the test material on group of seven male guinea pigs.

GLP compliance:

no

Type of study:

Draize test

Justification for non-LLNA method:

Currently no LLNA study is available for assessment. The Non-LLNA Draize test has been carried out as an animal test to predict human sensitization for over a decade and is recommended by international test guidelines such as OECD.

Test material

Test material information

Constituent 1

Reference substance name:

Dodecan-1-ol, ethoxylated

EC Number:

500-002-6

EC Name:

Dodecan-1-ol, ethoxylated

Cas Number:

9002-92-0

Molecular formula:

C58H118024

IUPAC Name:

Dodecan-1-ol, ethoxylated

Test material form:

liquid

Details on test material:

- Name of test material (as cited in study report): Dodecan-1-ol, ethoxylated
- Substance type: Organic
- Physical state: liquid

In vivo test system

Test animals

Species:

guinea pig

Strain:

not specified

Sex:

male

Details on test animals and environmental conditions:

Not specified

Study design: in vivo (non-LLNA)

Induction

Route:

intradermal

Vehicle:

other: Distilled water

Concentration / amount:

First group: a series of ten intracutaneous injections of a 0.02% solution
Second group: a series of ten injections of a 0.1% solution of the formulation were given
Third group: sterile distilled water was injected.

Day(s)/duration:

3 weeks

Adequacy of induction:

not specified

Challenge

No.:

#1

Route:

intradermal

Vehicle:

other: Distilled water

Concentration / amount:

0.05 ml

Day(s)/duration:

24 hours

Adequacy of challenge:

not specified

No. of animals per dose:

seven guinea pigs/group

Details on study design:

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 10
- Exposure period: 24 hours
- Test groups: seven guinea pigs/group
- Control group:
- Site: not specified
- Frequency of applications: every other day, three times each week.
- Duration: 3 weeks
- Concentrations: 0.02% and 0.1%

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: after 2 week
- Exposure period: 24 hours
- Test groups: seven guinea pigs/group
- Control group: not specified
- Site: not specified
- Concentrations: 0.05ml
- Evaluation (hr after challenge): after 24 hours

OTHER: Twenty-four hours after each injection, the injection sites were examined and the dimensions and color of the reactions were recorded.

Challenge controls:

not specified

Positive control substance(s):

not specified

Results and discussion

In vivo (non-LLNA)

Results

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

Dose level:

0.05ml

No. with + reactions:

0

Total no. in group:

7

Clinical observations:

Neither the 0.02% solution of test chemical nor a 0.1% solution of the aerosol formulation containing 20% of test chemical produced direct or delayed sensitization reactions.

Remarks on result:

no indication of skin sensitisation

Applicant's summary and conclusion

Interpretation of results:

other: not sensitizing

Conclusions:

Neither the 0.02% solution of test chemical nor a 0.1% solution of the aerosol formulation containing 20% of test chemical produced direct or delayed sensitization reactions in adult male guinea pigs when injected intracutaneously.
Hence the test chemical was considered to be a non-skin sensitizer under the tested conditions.

Executive summary:

The test material was tested as an aqueous solution and as an ingredient of an aerosol contraceptive formulation containing 20% test chemical to determine if sensitization reactions were produced on group of 7 male guinea pigs.

 

To a group of seven male guinea pigs a series of ten intracutaneous injections of a 0.02% solution of test chemical were administered; to a second group a series of ten injections of a 0.1% solution of the formulation were given; and to a third group (control) sterile distilled water was injected.

 

The sensitizing injections were given every other day, three times each week. The volume of the first dose was 0.05 ml and that of the other nine was 0.1 ml. Two weeks after the tenth sensitizing injection, the guinea pigs received a single challenge injection of 0.05 ml of a freshly prepared solution of the material to which they were sensitized. Twenty-four hours after each injection, the injection sites were examined and the dimensions and color of the reactions were recorded.

 

Intracutaneous injections of all the solutions, including the sterile water control, produced a small raised anemic area approximately 7 mm in diameter and 1 mm in height. This reaction was transient and did not last for more than 3 hours.

 

Further neither the 0.02% solution of test chemical nor a 0.1% solution of the aerosol formulation containing 20% of test chemical produced direct or delayed sensitization reactions in adult male guinea pigs when injected intracutaneously. Hence the test chemical was considered to be a non-skin sensitizer under the tested conditions.