Methyl (3aR,4R,7aR)-2-methyl-4-(1S,2R,3-triacetoxypropyl)-3a,7a-dihydro-4H-pyrano[3,4-d]oxazole-6-carboxylate

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation

Adequacy of study:

other information

Data source

Reference

Reference Type:

other: Body responsible for the test

Title:

Unnamed

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Annex V

GLP compliance:

yes

In vivo test system

Test animals

Species:

other: Albino guinea pigs

Study design: in vivo (non-LLNA)

Induction

Concentration / amount:

Concentration of test material and vehicle used at induction:
Intradmal induction - 5%w/v in achachis oil

- 5% w/v in a mixture of freund's
complete adjuvant plus arachis oil

Topical induction - 50% w/w in arachis oil

Concentration of test material and vehicle used for each challenge:
50 and 25% in arachis oil.

Challenge

Concentration / amount:

Concentration of test material and vehicle used at induction:
Intradmal induction - 5%w/v in achachis oil

- 5% w/v in a mixture of freund's
complete adjuvant plus arachis oil

Topical induction - 50% w/w in arachis oil

Concentration of test material and vehicle used for each challenge:
50 and 25% in arachis oil.

No. of animals per dose:

Number of animals in test group: 20
Number of animals in negative control group: 10

Results and discussion

Any other information on results incl. tables

Maximum concentration not causing irritating effects in preliminary test: 5 %

Signs of irritation during induction:
Topical induction - 5,10,25 and 50% gave a score of 1
(scattered mild redness) at the one hour reading and 50%
also gave a score of 1 at the 24 hour reading.


50% topical challenge gave a score of 1 at one hour.

Evidence of sensitisation of each challenge concentration:
2/20 animals showed evidence of sensitisation

Applicant's summary and conclusion

Interpretation of results:

other: not classified