Registration Dossier

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: well performed OECD and GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report Date:
1988

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes
Type of study:
guinea pig maximisation test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Acetessig-m-Xylidid TF

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Pirbright-White Hoe: DHPK(SPFLac)
Sex:
female
Details on test animals and environmental conditions:
- Source: Hoechst AG, Kastengrund, SPF breed
- Weight: mean: 294 g (260 g - 344 g, n=15)
- Randomisation: acc. to plan No 390/88
- Housing: in air conditioned rooms, groups of 5 animals
- Temperature: 22 +/- 3 °C
- Rel. humidity: 50 +/- 20 %
- Artificial light: 12 hrs daily
- Acclimatisation: min 5 days
- Diet: Altromin 3112, ad libitum
- Water: tap water in plastic bottels, ad libitum
- Labelling: Numbering of cages as well as labelling of pelt with KMnO4

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
other: paraffin (DAB), petrolatum (DAB)
Concentration / amount:
Intradermal induction treatment:
1.0 % test substance in paraffin (DAB) and 1.0 % test substance in 50% Freund's adjuvants

Epicutaneous induction treatment:
2.5 % test substance in petrolatum (DAB)

Epicutaneous challange exposure:
0.25 % test substance in petrolatum (DAB)
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: paraffin (DAB), petrolatum (DAB)
Concentration / amount:
Intradermal induction treatment:
1.0 % test substance in paraffin (DAB) and 1.0 % test substance in 50% Freund's adjuvants

Epicutaneous induction treatment:
2.5 % test substance in petrolatum (DAB)

Epicutaneous challange exposure:
0.25 % test substance in petrolatum (DAB)
No. of animals per dose:
5 animals in control group, 10 animals in treatment group

in the case of equivocal results a double number of test animals is scheduled

historical laboratory data show, that the initial number of animals usually is sufficient to come to a final conclusion
Details on study design:
- Study day 1: Intradermal induction exposure
- Study day 9: Epicutaneous induction exposure
- Study day 22: Epicutaneous challenge exposure
- Study day 24: 1st reading
- Study day 25: 2nd reading
Positive control substance(s):
not specified

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
Dose level:
intradermal induction 0%, epicutaneous induction 0%
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
without abnormal findings
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: intradermal induction 0%, epicutaneous induction 0%. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: without abnormal findings.
Reading:
1st reading
Hours after challenge:
48
Group:
test group
Dose level:
intradermal induction 1%, epicutaneous induction 2.5%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
without abnormal findings
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: intradermal induction 1%, epicutaneous induction 2.5%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: without abnormal findings.
Reading:
2nd reading
Hours after challenge:
72
Group:
negative control
Dose level:
intradermal induction 0%, epicutaneous induction 0%
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
without abnormal findings
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: negative control. Dose level: intradermal induction 0%, epicutaneous induction 0%. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: without abnormal findings.
Reading:
2nd reading
Hours after challenge:
72
Group:
test group
Dose level:
intradermal induction 1%, epicutaneous induction 2.5%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
without abnormal findings
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: intradermal induction 1%, epicutaneous induction 2.5%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: without abnormal findings.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
Based on these findings the test substance was considered not to be a skin sensitiser.
Executive summary:

The test item was tested for skin sensitising properties in a guinea pig maximisation test. Intradermal induction treatment was done with a 1% concentration of the test item in paraffin, epicutaneous induction treatment was done using a 2.5% concentration of the test item in petrolatum. Dermal challenge treatment was done using a 0.25% concentration of the test item in petrolatum. Neither animals of the control group nor animals of the dose group showed a skin response after challenge treatment. Based on these findings the test substance was considered not to be a skin sensitiser.