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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
key study
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
other: Information from migrated NONS file, as per inquiry number 06-2120053365-59- 0000, permission to refer granted by ECHA
Title:
Unnamed
Year:
2014

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

Constituent 1
Reference substance name:
Automatically generated during migration to IUCLID 6, no data available
IUPAC Name:
Automatically generated during migration to IUCLID 6, no data available
Details on test material:
EC number 401-560-2
Notification number 87-04-0062-02
Result Partly provided (some studies submitted less than 12 years previously)

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: gpg, Bor:DHPW (SPF)
Sex:
not specified

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
water
Concentration / amount:
a) Intradermal induction: 0.5 %
b) Topical induction: 10 %
Challengeopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
water
Concentration / amount:
a) Intradermal induction: 0.5 %
b) Topical induction: 10 %
No. of animals per dose:
Number of animals in test group: 20
Number of animals in negative control group: 20
Challenge controls:
Concentration of test material and vehicle used for each challenge:
1st and 2nd challenge: 10 %

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0.5%
No. with + reactions:
10
Total no. in group:
10
Clinical observations:
e differences in the thickness of the skin fold of the animals induced with substance
Remarks on result:
other: see Remark
Remarks:
Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.5%. No with. + reactions: 10.0. Total no. in groups: 10.0. Clinical observations: e differences in the thickness of the skin fold of the animals induced with substance.
Reading:
2nd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
0.5%
No. with + reactions:
10
Total no. in group:
10
Clinical observations:
slightly weakened after 72 h.
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 0.5%. No with. + reactions: 10.0. Total no. in groups: 10.0. Clinical observations: slightly weakened after 72 h..

Applicant's summary and conclusion

Interpretation of results:
other: irritant