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Toxicological information

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:
1992
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Report Date:
1992

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Old study available from the time where the non-LLNA study was not available

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
Purity: 95.6%
Product code: HOE CG 0418 OD ZD96 0001

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Hoe: DHPK (SPFLac)
Sex:
female

Study design: in vivo (non-LLNA)

Induction
Route:
intradermal and epicutaneous
Vehicle:
petrolatum
Challenge
Route:
epicutaneous, semiocclusive
Vehicle:
petrolatum
No. of animals per dose:
10 amimals in the treatment group and 5 animals in the control

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
48
Group:
test group
Dose level:
1% C.I. Pigment Red 3 in petrolatum
No. with + reactions:
4
Total no. in group:
10
Clinical observations:
Very slight up to well-defined erythema and very slight oedema were observed in four animals
Remarks on result:
other: see Remark
Remarks:
Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 1% C.I. Pigment Red 3 in petrolatum. No with. + reactions: 4.0. Total no. in groups: 10.0. Clinical observations: Very slight up to well-defined erythema and very slight oedema were observed in four animals.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
1% C.I. Pigment Red 3 in petrolatum
No. with + reactions:
1
Total no. in group:
10
Clinical observations:
One animal of the treated group showed very slight to well-defined erythema
Remarks on result:
other: see Remark
Remarks:
Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 1% C.I. Pigment Red 3 in petrolatum. No with. + reactions: 1.0. Total no. in groups: 10.0. Clinical observations: One animal of the treated group showed very slight to well-defined erythema.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Executive summary:

Testing for sensitizing properties of Pigment Red 3 was performed in female Guinea pigs according to the method of Magnusson & Kligman.

Intra dermal induction was performed using 0.2% Pigment Red 2 in semi-liquid paraffin. Dermal induction was carried out with 5%, challenge treatment with 1% Pigment Red 3 in petrolatum.

Four animals of the treatment group showed a positive skin response after the first challenge procedure and one animal reacted after the second challange. If the effects observed at the first challange are due to sensitization, then equal or even stronger reactions would be expected after the second challenge procedure. Therefore, the reactions noted in the three other animals at the first challange are considered to be rather unspecific irritation effects than allergic reactions.

Based on the results of this study Pigment Red 3 is not considered to be a skin sensitizer.