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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Study meets generally accepted scientific principles as a modification of a standard Draize test procedure, selection of test concentrations based on preliminary irritation tests both for intradermal injection and topical application, suffcient description of test protocol; minor restrictions: only qualitative test result presented in a table, no data on sensitisation scores for the test group or individual test animals; limited number of 10 test animals, no replicate study; study acceptable as supporting information

Data source

Reference
Reference Type:
publication
Title:
The sensitization potential of some perfume ingredients tested using a modified Draize procedure
Author:
Sharp DW
Year:
1978
Bibliographic source:
Toxicology 9: 261-271

Materials and methods

Principles of method if other than guideline:
Draize test with modified protocol for induction
GLP compliance:
no
Type of study:
Draize test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Purity: commercial batch

In vivo test system

Test animals

Species:
guinea pig
Strain:
Hartley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: inbred from own colony
- Weight at study initiation: 350 g
- Housing: in pairs
- Diet: ad libitum
- Water: ad libitum

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
no data
Concentration / amount:
Intradermal injection challenge concentration (ICC): 0.25 %
Topical application challenge concentration (ACC): 20 %
Challengeopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
no data
Concentration / amount:
Intradermal injection challenge concentration (ICC): 0.25 %
Topical application challenge concentration (ACC): 20 %
No. of animals per dose:
10
Details on study design:
- Induction treatment:
0.1 ml aliquots of the test substance at 2.5 times the injection challenge concentration were administered on one occasion as 4 intradermal injections at 4 sites which overlie the 2 auxiliary and 2 inguinal lymph nodes. Induction time was 14 days.

- Challenge treatment:
Intradermal injection in one flank and topical application on the other flank by spreading 0.1 ml of the test substance onto the shaved flank in a small circular area which was not covered.

- Scoring of reactions:
24 hrs later
Apparent sensitization reactions were confirmed 7 days later by a second challenge.
In the absence of sensitisation reactions at first challenge, the induction and challenge procedures were repeated, but htis time a confirmatory challenge with controls was included.

- Controls:
At each challenge 4 previously untreated animals of the same sex and similar weight to the test animals were treated intradermally and topically on opposite flanks with 0.1 ml aliquots of test substance at the ICC and ACC, respectively.

- Scoring:
Injection reaction: total score based on size, erythema and oedema.
Positive reaction: total score of individual reaction significantly greater than the total average score for control reactions.
Application reaction: 0 to +++ scale
Positive reaction: (a) scoring >= + and (b) no erythema reactions in controls
Positive control substance(s):
yes
Remarks:
other test substances that yielded positive test results

Results and discussion

Any other information on results incl. tables

Negative (no details of test results reported).

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
Acetophenone was assessed as non-sensitiser in a modified Draize test with Hartley guinea pigs.