Hexadecyl acetate

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

19 October 1956 to 27 December 1956

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Meets generally accepted scientific standards, well documented and acceptable for assessment.

Cross-reference

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1956

Report date:

1956

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

Intracutaneous injection of test material in physiological saline on alternate days to a total of ten injections in each of eight male guinea pigs.

GLP compliance:

no

Remarks:

investigation took place prior to introduction of GLP

Type of study:

intracutaneous test

Test material

Test material information

Constituent 1

Reference substance name:

Hexadecyl acetate

EC Number:

211-103-7

EC Name:

Hexadecyl acetate

Cas Number:

629-70-9

Molecular formula:

C18H36O2

IUPAC Name:

hexadecyl acetate

Details on test material:

- Name of test material (as cited in study report): Acetulan
- Analytical purity: Declared by owner of study report to contain 90 % test item and to be equivalent to the substance described elsewhere in this dossier
- Lot/batch No.: 107

In vivo test system

Test animals

Species:

guinea pig

Strain:

other: White

Sex:

male

Details on test animals and environmental conditions:

- Eight, normal, healthy, white male guinea pigs, each weighing 300 to 400 g, were used for the experiment.
- Animals were maintained on a regular diet of rabbit pellets supplemented with spinich and kale throughout the experiment.
- As much hair as possible was removed from the sides and back of each guinea pig with electric clippers.

Study design: in vivo (non-LLNA)

Induction

Induction 1

Route:

intradermal

Vehicle:

physiological saline

Induction 2

Concentration / amount:

0.1 % suspension of test material

Challenge

Challenge 1

Route:

intradermal

Vehicle:

physiological saline

Challenge 2

Concentration / amount:

0.1 % suspension of test material

No. of animals per dose:

Eight

Details on study design:

- The test material was made up as a 0.1 % suspension in physiological saline and injected using a 0.25 mL syringe with a 0.5 inch 26 gauge needle.
- Injections were made every other day until a total of ten had taken place.
- The first injection was 0.05 mL while the remaining injections were all 0.1 mL.
- An area consisting of 3-4 cm2 was used for the site of the injection. However, the inital injection was given slightly below the sensitisation area.
- Two weeks after the final injection, a test injection of 0.05 mL of a freshly prepared suspension was administered.
- Reaction readings were made 24 hours after the initial and final 0.05 mL injections.

Positive control substance(s):

no

Results and discussion

Positive control results:

Not applicable

In vivo (non-LLNA)

Results

Results 1

Reading:

1st reading

Clinical observations:

Small raised areas

Remarks on result:

other: Reading: 1st reading. Clinical observations: Small raised areas.

Results 2

Reading:

rechallenge

Clinical observations:

No effects greater than initial injection

Remarks on result:

other: Reading: rechallenge. Clinical observations: No effects greater than initial injection.

Any other information on results incl. tables

- Twenty four hours after the initial injection, small raised areas were observed.

- These areas showed a slight increase in colour when compared to the surrounding area.

- The swellings were approximately 4-5 mm in diameter and 3-4 mm in height.

- Fourteen days after the last sensitising injection was given, 0.05 mL of a new 0.1 % suspension showed no greater effects than did the initial injection.

Applicant's summary and conclusion

Interpretation of results:

not sensitising

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test material produced no sensitising effects in the guinea pig.

Executive summary:

METHOD

A mixture declared to contain 90 % of test item was prepared as a 0.1 % suspension in physiological saline and administered to eight male guinea pigs by intracutaneous injection (initial injection of 0.05 mL in physiological saline followed by injections of 0.1 mL to a total of ten).

RESULTS

Twenty four hours after the initial injection, small raised areas were observed. These areas showed a slight increase in colour when compared to the surrounding area and the swellings were approximately 4-5 mm in diameter and 3-4 mm in height.

Fourteen days after the last sensitising injection was given, 0.05 mL of a new 0.1 % suspension showed no greater effects than did the initial injection.

CONCLUSION

The test material produced no sensitising effects in the guinea pig.