Registration Dossier

Administrative data

Description of key information

A mixture of hexadecyl acetate 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. Hexadecyl acetate produced no sensitising effects in the guinea pig.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
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
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
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.
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
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.
Reading:
1st reading
Dose level:
0.05 mL of 0.1% suspension
Remarks on result:
no indication of skin sensitisation

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.

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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the information available the substance does not need to be classified for sensitization according to EC Regulation 1272/2008 (CLP).