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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Based on the available date (GPMT), the substance is not skin sensitising.

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: Directive 84/449/EEC B5 (maximixation test) OECD 406 1981
Deviations:
not specified
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
The test was performed before the REACH regulation.
Species:
guinea pig
Strain:
not specified
Sex:
not specified
Route:
intradermal and epicutaneous
Vehicle:
propylene glycol
Concentration / amount:
induction:
intradermal 0.1 ml of 1% w/w in propylene glycol
epidermal: 0.5 ml of 25% w/w in propylene glycol
challenge: 0.5 ml of 25% w/w in propylene glycol
Route:
other: epicutaneous
Vehicle:
propylene glycol
Concentration / amount:
induction:
intradermal 0.1 ml of 1% w/w in propylene glycol
epidermal: 0.5 ml of 25% w/w in propylene glycol
challenge: 0.5 ml of 25% w/w in propylene glycol
No. of animals per dose:
20 animals in test group
Challenge controls:
10 animals in negative control group
Positive control substance(s):
no
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
25%
No. with + reactions:
2
Total no. in group:
20
Clinical observations:
no data
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
10%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
no data
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
5%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
no data
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
25%
No. with + reactions:
0
Total no. in group:
2
Clinical observations:
no data
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
10%
No. with + reactions:
1
Total no. in group:
20
Clinical observations:
no data
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
5%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
no data
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
25%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no data
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
25%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no data

Maximum concentration not causing irritation in preliminary tests: 25%.


Signs of irritation during induction: 0/10


Evidence of sensitisation of each challenge concentration: 3/20


 


Other observations:


No skin reaction observed in any of the control aninals


1 animal showed scaliness in the substance treated group


 

Interpretation of results:
GHS criteria not met
Remarks:
Not skin sensitizer
Conclusions:
The substance is not skin sensitising
Executive summary:

Due to the lack of information provided by ECHA, it is difficult to assess this end point fully.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

No evidence of respiratory effects from historical use. Risk management measures are in place to reduce the risk of inhalation.

Justification for classification or non-classification

Based on the available data, no classification for skin sensitisation is required according to the Regulation EC 1272/2008.