Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Skin sensitisation

Currently viewing:

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report date:
2001

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
1992
GLP compliance:
yes (incl. QA statement)
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
A GPMT was available.

Test material

Constituent 1
Reference substance name:
Blue REg 6080
IUPAC Name:
Blue REg 6080

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Ibm:GOHI (Himalayan spotted)
Sex:
female

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
polyethylene glycol
Concentration / amount:
10 %
Day(s)/duration:
day 1
Adequacy of induction:
highest technically applicable concentration used
Route:
intradermal
Vehicle:
other: 1:1 Freund's complete adjuvant and physiological saline
Concentration / amount:
10 %
Day(s)/duration:
day 1
Adequacy of induction:
highest technically applicable concentration used
Route:
epicutaneous, occlusive
Vehicle:
polyethylene glycol
Concentration / amount:
30 %
Day(s)/duration:
day 8 / 24 h
Adequacy of induction:
highest technically applicable concentration used
Challenge
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
polyethylene glycol
Concentration / amount:
30 %
Day(s)/duration:
day 22 / 24 h
Adequacy of challenge:
highest non-irritant concentration
No. of animals per dose:
Number of animals in test group: 10
Number of animals in negative control group: 5
Number of animals in pretest: 3
Positive control substance(s):
yes
Remarks:
2-mercaptobenzothiazole

Results and discussion

Positive control results:
All animals showed positive response after intradermal induction at 5 % in mineral oil and in an emulsion of Freund's adiuvant and physiological saline and epidermal induction at 15 % in mineral oil. Challenge with positive control was done at 1 % in mineral oil 2 weeks after epidermal induction.
Performed from October 3rd to November 20th, 2000.

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
0 %
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no skin reactions
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0 %
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no skin reactions
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
30 %
No. with + reactions:
6
Total no. in group:
10
Clinical observations:
discrete/patchy to moderate/confluent erythema; blue discoloration
Remarks on result:
positive indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
30 %
No. with + reactions:
5
Total no. in group:
10
Clinical observations:
discrete/patchy to moderate/confluent erythema; blue discoloration
Remarks on result:
positive indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0 %
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
no skin reactions
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0 %
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
no skin reactions
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
30 %
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
no skin reactions; blue discoloration
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
30 %
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
no skin reactions; blue discoloration
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
1 %
No. with + reactions:
10
Total no. in group:
10
Remarks on result:
positive indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
1 %
No. with + reactions:
10
Total no. in group:
10
Remarks on result:
positive indication of skin sensitisation

Any other information on results incl. tables

Maximum concentration not causing irritating effects in preliminary test by epicutaneous application: 30 %

Signs of irritation during induction: possible erythema reaction could not be determined due to substance-related blue staining of the skin.

Applicant's summary and conclusion

Interpretation of results:
other: skin sensitising cat. 1B within the CLP Regulation (EC 1272/2008)
Conclusions:
GPMT: > 30 % animals with positive response upon an intradermal induction with test item at 10 %.
Skin sensitising.