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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Well documented guideline study but non-GLP-Conditions and no details on testsubstance in study report. The identity of testsubstance is documented outside the report at site of study owner.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
GLP compliance:
no
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
In Vivo-Test from 1995 already available.

Test material

Constituent 1
Reference substance name:
1,8-Naphthostyril
IUPAC Name:
1,8-Naphthostyril

In vivo test system

Test animals

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

Study design: in vivo (non-LLNA)

Induction
Route:
intradermal
Vehicle:
polyethylene glycol
Concentration / amount:
4 g/ 100 ml
Challenge
Route:
intradermal
Vehicle:
polyethylene glycol
Concentration / amount:
4 g/100 ml
No. of animals per dose:
10

Results and discussion

Positive control results:
No effects of sensitization were observed.

In vivo (non-LLNA)

Results
Reading:
rechallenge
Hours after challenge:
72
Group:
test chemical
Dose level:
see above
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No effect observed.
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 72.0. Group: test group. Dose level: see above. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: No effect observed. .

Any other information on results incl. tables

See attached full study report.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
According to the criteria of Magnusson and Kligman Naphthostyril is not sensitising to skin.