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EC number: 219-372-2
CAS number: 2425-85-6
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.
Skin sensitising potential of Pigment Red 3
was tested in female Guinea pigs. Four animals of the treatment group
showed a positive skin response after the first challenge procedure and
one animal reacted after the second challenge. If the effects observed
at the first challange are due to sensitization, then equal or even
stronger reactions would be expected after the second challange
procedure. Therefore, the reactions noted in the three other animals at
the first challenge 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.
The following information is taken into
account for any hazard / risk assessment:
Pigment Red 3 has been tested in female
Guinea pigs to assess the sensitising potential of the test item. Based
on the results of this study Pigment Red 3 is not considered to be a
Value used for CSA: not
Respiratory tract sensitisation:
Substance is not classified for this
endpoint. The substance is considered not to exert any sensitizing
effects on the respiratory tract; when aerosolized in respirable form,
the substance is considered likely to behave like an inert dust.
Non-human information: This information is
Pigment Red 3 did not show skin sensitising
properties in female Guinea pigs. No skin reactions were seen in 28
healthy young female volunteers in a 48 hour patch test with 1% C.I.
Pigment Red 3 in petrolatum (Kgzuka et al.1980)
However allergic skin reactions or case
reports of acute contact dermatitis to Pigment Red 3 have been described
in the literature. Slight erythema or erythema with edema were observed
in patients with pigmented cosmetic dermatitis in patch or photopatch
tests with C.I. Pigment Red 3 after application for 48 or 72 hours.
Positive reactivity was 34.2% (13/38) (Sugai et al.1977). The reddening
and swelling of the skin were seen in five of 155 patients with cosmetic
dermatitis in a 48-h path tests with 5% C.I. Pigment Red 3 in
polyethylene glycol; slight reddening was seen in another 25 of the
patients (MJCDRG 1978). In a patch test, negative reaction was observed
with 1% Pigment Red 3 (in petrolatum) in the skin of patients who were
suffered from dermatitis caused by Brilliant Lake Red R.
It can reasonably be deduced that Pigment Red
3 does not cause respiratory tract sensitization and thus does not have
to be classified according to the criteria laid down in the EU Dangerous
Substances Directive (67/548/EEC) and in the EU Classification Labelling
and Packaging Regulation (1272/2008/EC), because
- Pigment Red 3 did not cause skin
- it is unlikely that Pigment Red 3 can
interact with the immune system due to its extremely low solubility in
water and n-octanol.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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