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Diss Factsheets

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:
1979-11-05 to 1980-01-23
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report date:
1980

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
other: "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959), the US Association of Food and Drug Officials (AFDO)
Deviations:
not specified
GLP compliance:
no
Type of study:
Freund's complete adjuvant test
Justification for non-LLNA method:
No LLN study has been performed since valid data obtain in guinea pigs are available.

Test material

Constituent 1
Chemical structure
Reference substance name:
Cobaltate(1-), bis[2-(3-chlorophenyl)-2,4-dihydro-4-[[2-hydroxy-5-(methylsulfonyl)phenyl]azo]-5-methyl-3H-pyrazol-3-onato(2-)]-, hydrogen, compd. with [1R-(1α,4aβ,10aα)]-1,2,3,4,4a,9,10,10a-octahydro-1,4a-dimethyl-7-(1-methylethyl)-1-phenanthrenemethanamine (1:1)
EC Number:
243-855-7
EC Name:
Cobaltate(1-), bis[2-(3-chlorophenyl)-2,4-dihydro-4-[[2-hydroxy-5-(methylsulfonyl)phenyl]azo]-5-methyl-3H-pyrazol-3-onato(2-)]-, hydrogen, compd. with [1R-(1α,4aβ,10aα)]-1,2,3,4,4a,9,10,10a-octahydro-1,4a-dimethyl-7-(1-methylethyl)-1-phenanthrenemethanamine (1:1)
Cas Number:
20506-24-5
Molecular formula:
C34 H26 Cl2 Co N8 O8 S2 . C20 H31 N . H
IUPAC Name:
(2Z,2'Z)-7,7'-bis(3-chlorophenyl)-15,15'-dimethanesulfonyl-5,5'-dimethyl-9,9',11,11'-tetraoxa-2,2',3,3',6,6',7,7'-octaaza-10-cobalta-10,10'-spirobi[tricyclo[10.4.0.0⁴,⁸]hexadecane]-1(12),1'(12'),2,2',4(8),4'(8'),5,5',13,13',15,15'-dodecaen-10-uide; [1,4a-dimethyl-7-(propan-2-yl)-1,2,3,4,4a,4b,8a,9,10,10a-decahydrophenanthren-1-yl]methanaminium

In vivo test system

Test animals

Species:
guinea pig
Strain:
Pirbright-Hartley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Bantin and Kingman Ltd. Grimston, Hull, England
- Weight at study initiation: 385 - 404 g (f); 395 - 401 g (m)
- Housing: individually in macrolon cages (Type 3)
- Diet: ad libitum, standard diet (NAFAG, No. 830, Gossau SG)
- Water: ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±2
- Humidity (%): 55±10
- Photoperiod (hrs dark / hrs light): 14/10

Study design: in vivo (non-LLNA)

Induction
Route:
epicutaneous, open
Vehicle:
propylene glycol
Concentration / amount:
Induction: 0.1 % in physiological saline (during 2nd and 3rd week the test substance was solved in a 1:1 mixture of normal vehicle and Freund complete adjuvant)
Challenge
Route:
intradermal and epicutaneous
Vehicle:
propylene glycol
Concentration / amount:
epicutaneous: 0.1 % in physiological saline
intradermal: 30 % in vaseline
No. of animals per dose:
20 (10/sex)
Details on study design:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 10
- Test group: Injection of a freshly prepared suspension of the test substance
- Control group: Injection of the vehicle (propylene glycol)
- Site: right flank and the back
- Frequency of applications: every second day (except weekends)
- Duration: 3 weeks
- Concentrations: 0.1 %

B. CHALLENGE EXPOSURE (INTRADERMAL)
- No. of exposures: 1
- Day(s) after induction: 14 days
- Test group: Injection of a freshly prepared suspension of the test substance
- Control group: Injection of a freshly prepared suspension of the test substance
- Site: left flank and the back
- Concentrations: 0.1 %
- Evaluation (hr after challenge): 24 hours

C. CHALLENGE EXPOSURE (EPICUTANEOUS)
- No. of exposures: 1
- Days after induction: 24 days
- Test group: Epicutaneous application of the test substance in vaseline.
- Control group: Epicutaneous application of the test substance in vaseline.
- Site: left flank and the back
- Concentrations: 30 %
- Evaluation (hr after challenge): 24 hours
Challenge controls:
Not available
Positive control substance(s):
no

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
other: Reading after intradermal exposure
Hours after challenge:
24
Group:
negative control
Dose level:
0.1 %
No. with + reactions:
4
Total no. in group:
20
Reading:
other: Reading after intradermal exposure
Hours after challenge:
24
Group:
test chemical
Dose level:
0.1 %
No. with + reactions:
17
Total no. in group:
20
Reading:
other: Reading after epicutaneous occlusive exposure
Hours after challenge:
24
Group:
negative control
Dose level:
30 % in vaseline
No. with + reactions:
0
Total no. in group:
20
Reading:
other: Reading after epicutaneous occlusive exposure
Hours after challenge:
24
Group:
test chemical
Dose level:
30 % in vaseline
No. with + reactions:
0
Total no. in group:
20

Any other information on results incl. tables

Under the experimental conditions employed, significant differences between the test group and the vehicle treated controls were only seen after intradermal challenge application i.e. when the skin barrier was intentionally by-passed. No difference between the test and the control group was seen after epidermal challenge application. The negative results upon epidermal challenge demonstrate that, in artificially sensitized guinea-pigs, exposure

of the intact skin to the test compound does not provoke contact dermatitis.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met