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Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From July 24th to August 30th, 2002
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report date:
2002

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
Adopted July 17th, 1992
Qualifier:
according to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
Version / remarks:
Adopted July 30th, 1996
GLP compliance:
yes (incl. QA statement)
Type of study:
Buehler test
Justification for non-LLNA method:
A Buehler test was avaliable

Test material

Constituent 1
Reference substance name:
Yellow 6314-PPT
IUPAC Name:
Yellow 6314-PPT
Test material form:
solid

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: IbM: GOHI
Sex:
female

Study design: in vivo (non-LLNA)

Induction
Route:
epicutaneous, occlusive
Vehicle:
polyethylene glycol
Remarks:
PEG 300
Concentration / amount:
25%
Day(s)/duration:
1st, 8th, 15th day / 6h
Adequacy of induction:
highest technically applicable concentration used
Challenge
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
polyethylene glycol
Remarks:
PEG 300
Concentration / amount:
25%
Day(s)/duration:
29th day / 6h
Adequacy of challenge:
highest non-irritant concentration
No. of animals per dose:
Number of animals in the test group: 20
Number of animals in the negative control group: 10
Number of animals in the irritation screen: 4
Positive control substance(s):
yes
Remarks:
Alpha-Hexylcinnamaldehyde. Challenge: 20 test animals (males), 10 control animals (males); lrritation Screen: 4 animals (males). Performed from July 23rd, 2002 to August 29th, 2002

Results and discussion

Positive control results:
19 (at the 24-hour reading) and 17 (at the 48-hour reading) out of 20 test animals were observed with discrete/patchy to moderate/confluent erythema after the challenge treatment with the highest tested non-irritating concentration of Alpha-Hexylcinnamaldehyde at 5 % in PEG 300.

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
25%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
25%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
25%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
25%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
5 % in PEG
No. with + reactions:
19
Total no. in group:
20
Remarks on result:
positive indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
5 % in PEG 300
No. with + reactions:
17
Total no. in group:
20
Remarks on result:
positive indication of skin sensitisation

Any other information on results incl. tables

There were no deaths during the course of the study, hence no necropsies were performed. No symptoms of systemic toxicity were observed in the animals.

 

The second and third induction sites could not be evaluated due to the slight pigmentation of the skin still present from the first induction and the additional induction applications.

After challenge, animals were depilated 3 hours prior to the 24-hour reading to clean the skin area from the staining produced by the test item and to facilitate the reading of the skin reactions.

 

Applicant's summary and conclusion

Interpretation of results:
other: not classified according to the CLP Regulation (EC 1272/2008)
Conclusions:
Not skin sensitizer.

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