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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
other: Annex V (maximisation test)
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Test performed in 1992. LLNA method (OECD 442 B) was adopted in 2010 and also the (OECD tests n°442 C , D) was adopted in 2015.
Species:
guinea pig
Strain:
Dunkin-Hartley
Route:
intradermal and epicutaneous
Vehicle:
water
Concentration / amount:
concentration of test material and vehicle used at induction:
intradermal: 0.5 % v/v in water for irrigation
topical: 50% v/v in distilled water

Concentration of test material and vehicle used for each challenge:
5% v/v in distilled water
10% v/v in distilled water
Concentration / amount:
concentration of test material and vehicle used at induction:
intradermal: 0.5 % v/v in water for irrigation
topical: 50% v/v in distilled water

Concentration of test material and vehicle used for each challenge:
5% v/v in distilled water
10% v/v in distilled water
No. of animals per dose:
number of animals in test group: 30
number of animals in negative control group: 10
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
5%
No. with + reactions:
0
Total no. in group:
30
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
10%
No. with + reactions:
9
Total no. in group:
30
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
5%
No. with + reactions:
0
Total no. in group:
30
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
10%
No. with + reactions:
5
Total no. in group:
30
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
5%
No. with + reactions:
0
Total no. in group:
10
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
10%
No. with + reactions:
0
Total no. in group:
10
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
5%
No. with + reactions:
0
Total no. in group:
10
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
10%
No. with + reactions:
0
Total no. in group:
10
Reading:
1st reading
Group:
positive control
Remarks on result:
not measured/tested

Maximum concentration not causing irritating effects in preliminary test: 10%

Signs of irritation during induction: signs of slight irritation following intradermal injection and slight to moderate erythema after topical application.

Evidence of sensitization of each challenge concentration : 5%-0, 10%-6

Interpretation of results:
other: not classified
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification