[No public or meaningful name is available]

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:

test procedure in accordance with national standard methods with acceptable restrictions

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:

Prior to introduction of GLP

Type of study:

not specified

Justification for non-LLNA method:

Adequate existing data that allow a conclusion on the sensitizing potential of the substance were available

Test material

Test material information

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

In vivo test system

Test animals

Species:

guinea pig

Sex:

male

Details on test animals and environmental conditions:

Test animals Species: guinea pig
Strain: 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 spinach 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

Route:

intradermal

Vehicle:

physiological saline

Concentration / amount:

first induction 0.05 mL, thereafter 0.1 mL of a 0.1% suspension

Day(s)/duration:

10 days

Challenge

No.:

#1

Route:

intradermal

Vehicle:

physiological saline

Concentration / amount:

0.05 mL of 0.1% suspension 14 days after the last induction

Day(s)/duration:

1

Details on study design:

Induction
Route: intradermal
Vehicle: physiological saline
Concentration / amount: 0.1 % suspension of test material

Challenge
Route: intradermal
Vehicle: physiological saline
Concentration / amount: 0.1 % suspension of test material

Procedure
−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 initial injection was given slightly below the sensitization 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.

Results and discussion

In vivo (non-LLNA)

Results

Reading:

1st reading

Dose level:

0.05 mL of 0.1% suspension

Remarks on result:

no indication of skin sensitisation

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 color 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 sensitizing 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:

GHS criteria not met

Conclusions:

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

Executive summary:

A mixture of the substance 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).

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.

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