Registration Dossier

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1987
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: OECDTG406 and GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report date:
1988

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
guinea pig maximisation test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Purity:>99.9%
.

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
paraffin oil
Concentration / amount:
Induction
Intradermal injection 0.1% in liquid paraffin
Topical application 1.5% in liquid paraffin
Challenge 0.5% and 0.25% in liquid paraffin
Challengeopen allclose all
Route:
epicutaneous, semiocclusive
Vehicle:
paraffin oil
Concentration / amount:
Induction
Intradermal injection 0.1% in liquid paraffin
Topical application 1.5% in liquid paraffin
Challenge 0.5% and 0.25% in liquid paraffin
No. of animals per dose:
20
Details on study design:
1st application: Induction 0.1% intracutaneous
2nd application: Induction 1.5% semiocclusive
3rd application: Challenge 0.5, 0.25% semiocclusive
Positive control substance(s):
no

Results and discussion

Positive control results:
In this study, PMI is delayed contact hypersensitivity in all 20 animals.

In vivo (non-LLNA)

Results
Reading:
1st reading
Hours after challenge:
72
Group:
test chemical
Dose level:
0.5 wt% in liquid paraffin
No. with + reactions:
20
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 72.0. Group: test group. Dose level: 0.5 wt% in liquid paraffin. No with. + reactions: 20.0. Total no. in groups: 20.0.

Applicant's summary and conclusion

Interpretation of results:
sensitising
Remarks:
Migrated information
Conclusions:
Classification: skin sensitizing by animals.
No workers in company production site in Japan receive adverse effect on this substance.
Executive summary:

In a dermal sensitization study with PMI >99.5% provided by NIPPON SHOKUBAI 7Y09 in paraffin oil, female albino guinea-pigs of the Hartrey/Dunkin strain were tested using the method of OECD 406 "Skin Sensitisation".

The numerical scores awarded to the dermal reactions elicted by the challenge application are positve 20/20.

In this study, PMI is delayed contact hypersensitivity in all 20 animals. PMI is classified as the category 1 in accordance with GHS.