Hexadecyl lactate

Endpoint summary

Description of key information

Although the study was not performed according to presently available test mehods, the total lack of response makes it possible to take a reliable conclusion with respect to sensitizing potential of the test substance.

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:

1958

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: study done in pre-GLP period but sufficient detail reported

Qualifier:

no guideline followed

Principles of method if other than guideline:

The method used was based on scientifically accepted method.

GLP compliance:

no

Type of study:

intracutaneous test

Justification for non-LLNA method:

The alternative method used was based on scientifically accepted method and was performed before the LLNA requirement.

Species:

guinea pig

Strain:

not specified

Sex:

male

Details on test animals and environmental conditions:

the text animals were normal and healthy and were feed with rabbit pellets supplemented with spinach and kale through out the course of the experiment.

Route:

intradermal

Vehicle:

other: physiological saline

Concentration / amount:

0.1% / 0.05 - 0.1 ml

Day(s)/duration:

10 injections each every other day

Adequacy of induction:

not specified

Route:

intradermal

Vehicle:

other: physiological saline

Concentration / amount:

0.1% / 0.5 ml

Day(s)/duration:

Two weeks after the final test injection

Adequacy of challenge:

not specified

No. of animals per dose:

8

Details on study design:

Reaction readings were made 24 h after each injection.

Positive control substance(s):

no

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

Dose level:

0.1 %

No. with + reactions:

22

Total no. in group:

70

Clinical observations:

Not specified

Reading:

rechallenge

Hours after challenge:

24

Group:

test chemical

Dose level:

0.1%

No. with + reactions:

0

Total no. in group:

7

Clinical observations:

Not specified

Interpretation of results:

not sensitising

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test material is not sensitizing.

Executive summary:

Alhough a small raised area was observed with a slight increase in color when compared to surrounding area, but the retest reading value was less than the average for each reading. Thus, the substance can be said not to have produced sensitization.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

CERAPHYL® 28 with hexadecyl lactate as main constituent was not a sensitizer to guinea pig skin. Eight healthy male guinea pigs were treated using intracutaneous injections of 0.1% CERAPHYL® 28 in physiological saline every other day for a total of ten injections. The first injection was 0.05 ml and the remaining injections were 0.1 ml. Two weeks following the tenth injection, all animals were challenged with 0.05 ml of freshly prepared solution of CERAPHYL® 41 slightly below their sensitizing area . On the challenge injection, none of the test animals exhibited reactions higher than the average of the original scores. Although the test method is not equivalent to the method described in international guidelines, the total lack of response indicates that the test material is not sensitizing. In addition, comparable studies with other long-chain akyl lactates show that these are not sensitizing.

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

The test material was not classified since it did not induce sensitization. However, due to lack of data, no decision can be made regarding respiration sensitisation.