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Diss Factsheets

Administrative data

Description of key information

Macrolex Orange R was not sensitizing to the skin in a Guinea Pig Maximization Test according to to Magnussen and Kligman.

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
Study period:
1997
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Principles of method if other than guideline:
Guinea Pig Maximization Test according to to Magnussen and Kligman
GLP compliance:
yes (incl. QA statement)
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
The study was conducted 1997
Specific details on test material used for the study:
Batch No.: A 100941995
Purity: technical grade
solid red powder
Species:
guinea pig
Strain:
other: Hsd Poc:DH, Harlan Winkelmann
Sex:
male
Details on test animals and environmental conditions:
20 male Guinea pigs; room temperature: 22+/-3 degree Celsius; relative humidity: 40-60%; light dark cyrcle 12 hartificial light; air exchange rate >0 10 times per hour.
Route:
intradermal
Vehicle:
propylene glycol
Concentration / amount:
1%
Day(s)/duration:
single
Adequacy of induction:
highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Route:
epicutaneous, occlusive
Vehicle:
polyethylene glycol
Concentration / amount:
0.5 ml of a 25% suspension
Day(s)/duration:
single
Adequacy of induction:
highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
No.:
#10
Route:
epicutaneous, semiocclusive
Vehicle:
polyethylene glycol
Concentration / amount:
6%
Day(s)/duration:
72 h
Adequacy of challenge:
highest non-irritant concentration
No. of animals per dose:
10
Details on study design:
Guinea Pig Maximization Test according to to Magnussen and Kligman
Challenge controls:
Yes
Positive control substance(s):
no
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
Dose level:
6%
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
non
Remarks on result:
other: control group
Reading:
2nd reading
Hours after challenge:
72
Group:
negative control
Dose level:
6%
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
non
Remarks on result:
other: control group
Key result
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
6%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
non
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
72
Dose level:
6%
No. with + reactions:
1
Total no. in group:
10
Clinical observations:
non
Remarks on result:
no indication of skin sensitisation
Interpretation of results:
GHS criteria not met
Executive summary:

The Guinea Pig Maximization Test (GPMT) was performed on male guinea pigs to determine whether the test substance MACROLEX ORANGE R exhibits skin-sensitizing properties.

The study was conducted with the following test substance concentrations:

lntradermal induction: 1 %

Topical induction: 25%

Challenge: 6%

For the induction and the challenge treatment the test substance was formulated in propylene glycol to yield a suspension.

72 hours after the challenge the 6% test substance formulation led to skin reddening (grade 1) in 1/10 (10%) animals in the test group, but not after 48 hours. The challenge with a 6% test substance formulation showed no skin effects in the control group animals.

Under the conditions of the maximization test the test substance thus exhibits no skin-sensitization potential.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)

Respiratory sensitisation

Endpoint conclusion
Additional information:

no study available

Justification for classification or non-classification

Macrolex Orange R was not sensitizing to the skin in a Guinea Pig Maximization Test according to to Magnussen and Kligman. No classification is warranted