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Diss Factsheets

Administrative data

Description of key information

CLP: not classified

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin sensitisation: in vitro
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
an in vitro skin sensitisation study does not need to be conducted because adequate data from an in vivo skin sensitisation study are available
Justification for type of information:
The in vivo test is performed according to Novartis internal Tiered Testing Strategy as a regular set of tests for all substances during the development of the project. (TRD Development Manual Chapter C.26 requirements.)
The Novartis Pharma Data Set (NPDS) has been put in place many years before the REACh regulatio n was released and we have, since then, systematically acquired data for all substances (RM, IM, DS, reagents, etc.) on behalf of TRD and PCS, for internal and external classification purposes.
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
20.6.-14.7.1994
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
The maximisation test has been selected, because it is one of the recommended tests in the OECD guideline 406, adopted May 12, 1981, adapted July 17, 1992, as well as in Annex V, Part B of Council Directive 67/548/EEC (Commission Directive 92/69/EEC of July 31, 1992), and because the ~ensitivity of the method is
well known. The test has been performed in essence according to the original protocol of Magnusson and Kligman (J. invest. Dermatol. 52, 268-276, 1969; Contact Dermatitis 6, 46-50, 1980) .
Species:
guinea pig
Strain:
other: Pirbright White Strain (Tif:DHP)
Sex:
male/female
Details on test animals and environmental conditions:
The test was performed on a total of 10 male and 10 female guinea pigs in the test group and 5 males and 5 females in the control group, respectively, initially weighing between 323 to 399 g.
The animals were housed individually in Macrolon cages (Type 3), assigned to the different groups by means of random numbers generated by the random number generator, identified by individual ear tags, kept at a constant room temperature of 22+3°c, at a relative humidity of 30 to 70% and a 12 hours
light cycle day.
The animals received ad libitum standard guinea pig pellets - NAFAG No. 845, Gossau SG and fresh water. All batches of the diet are assayed for nutritive ingredients and contamination level by the manufacturer. Analytical results are available at the animal supply office.
The drinking water quality fulfilled the critical pa.rameters in the specifications of the "Schweizerisches Lebensmittelbuch" (Edition 1972). The results of the routine chemical examination of water at source (Grundwasserfassung Stein) as conducted periodically by the water authority (Baudepa.rtement des Kantons
Aargau, Abteilung Gewaesserschutz) are available to CIBA-GEIGY Limited, as well as the results of inhouse chemical analysis by the analytical laboratories of the Pharmaceutical Division, CIBA-GEIGY Limited.
Route:
intradermal and epicutaneous
Vehicle:
other: intradermal induction: Oleum arachidis; epidermal induction and challenge: vaseline
Concentration / amount:
Intradermal induction: 5% in Oleum arachidis (w/v)
Epidermal induction and challenge: 50 and 30% in vaseline, respectively
Route:
epicutaneous, occlusive
Vehicle:
other: intradermal induction: Oleum arachidis; epidermal induction and challenge: vaseline
Concentration / amount:
Intradermal induction: 5% in Oleum arachidis (w/v)
Epidermal induction and challenge: 50 and 30% in vaseline, respectively
No. of animals per dose:
10 male and 10 female guinea pigs in the test group and 5 males and 5 females in the control group
Details on study design:
Intradermal Induction
The concentration for the intradermal injections was selected on account of the solubility of the test article in standard vehicles and its local and systemic tolerability in a pretest. The following concentration of test article has been used for intradermal injection:
5% in Oleum arachidis (w/v).
Since 5% CGP 48933 stufe 9 in Oleum arachidis could be injected and was well tolerated, this concentration was used for the intradermal induction.
Epidermal Applications (induction and challenge)
The concentrations for the epidennal applications were selected on acc·ount of the primary irritation potential of the test article. The following concentrations of CGP 48933 stufe 9 have been examined on separate animals for the determination of the maximum subirritant concentration:
30 and 50% in vaseline.
50% was the highest possible concentration of the test article in vaseline.
Reactions were observed with 50% CGP 48933 stufe 9 in vaseline.
Challenge controls:
The sensitivity of the strain is checked once or twice a year with a known mild to moderate sensitiser, such as mercaptobenzothiazole, hexyl cinnamic aldehyde or potassiumdichromate.
Positive control substance(s):
yes
Remarks:
mercaptobenzothiazole, hexyl cinnamic aldehyde or potassiumdichromate
Positive control results:
The positive control substance 2-Mercaptobenzothiazole induced positive reactions in 20/20 animals.
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
vehicle control
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
intradermal: 5% in Oleum arachidis / epidermal: 50% in vaseline
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
vehicle control
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
intradermal: 5% in Oleum arachidis / epidermal: 50% in vaseline
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
48
Group:
positive control
Dose level:
50%
No. with + reactions:
20
Total no. in group:
20
Remarks on result:
positive indication of skin sensitisation
Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not classified

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

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Under the experimental conditions employed, none of the animals of the test group showed skin reactions 24 and 48 hours after removing the dressings.