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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
Maximised method, Magnusson and Kligman
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
At the time of testing the LLNA method did not exhist
Species:
guinea pig
Strain:
Hartley
Route:
intradermal
Vehicle:
water
Concentration / amount:
Material applied as 10% in water intradermally. Freunds complete adjuvant also applied intradermally.
Topical induction was with a 50% mixture in water following treatment with sodium lauryl sulphate.
Route:
intradermal
Vehicle:
water
Concentration / amount:
Material applied as 10% in water intradermally. Freunds complete adjuvant also applied intradermally.
Topical induction was with a 50% mixture in water following treatment with sodium lauryl sulphate.
Challenge controls:
Concentrations of test material and vehicle used at each stage of challenge: 50% mixture in petrolatum.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
50%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
50%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
50%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
Dose level:
50%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
1st reading
Group:
positive control
Remarks on result:
not measured/tested

 

 

Number of animals showing skin reactions after

 

Challenge concentrations of test substance

1st challenge

24hr      48hr

2nd challenge

24hr      48hr

Test group

50

0

0

 

 

Negative control group

50

0

0

 

 
Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

The substance was tested for skin sensitisation following EU Method B6 -Guine Pig Maximisation Test (1993). The substance did not show any potential to be a skin sensitizer.

Migrated from Short description of key information:

Skin sensitisation, GPMT, not sensitising

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification