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The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Skin sensitisation

Currently viewing:

Administrative data

Endpoint:
skin sensitisation, other
Remarks:
non LLNA
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study well documented, meets generally accepted scientific principles, acceptable for assessment. GLP compliant including certificate.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report date:
1994

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Existing study well reported and performed under GLP.

Test material

Constituent 1
Chemical structure
Reference substance name:
Sodium 4-chloro-3-[4-[[5-chloro-2-(2-chlorophenoxy)phenyl]azo]-4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-1-yl]benzenesulphonate
EC Number:
276-675-2
EC Name:
Sodium 4-chloro-3-[4-[[5-chloro-2-(2-chlorophenoxy)phenyl]azo]-4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-1-yl]benzenesulphonate
Cas Number:
72479-28-8
Molecular formula:
C22H14Cl3N4NaO5S
IUPAC Name:
sodium 4-chloro-3-[4-[[5-chloro-2-(2-chlorophenoxy)phenyl]azo]-4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-1-yl]benzenesulphonate
Test material form:
solid

In vivo test system

Test animals

Species:
guinea pig
Strain:
Himalayan
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS- number of animals: 5 males / 5 females in pre-test and 10 males/10 females for the test- Weight at study initiation: 332 - 412 g- Housing: Individually in Makrolon type-3 cages with standard softwood bedding - Diet : Pelleted standard NAFAG No. 845; guinea pig breeding/ maintenance diet, ad libitum.- Water: tap water , ad libitum. ENVIRONMENTAL CONDITIONS- Temperature (°C):22 ± 3°C- Humidity (%): 30-70 %- Photoperiod : 12 hours artificial fluorescent light/12 hours dark.

Results and discussion

Positive control results:
No data

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
0
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
No systemic symptoms were observed.
Remarks on result:
other: No systemic symptoms were observed..
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
No systemic symptoms were obseved.
Remarks on result:
other: No systemic symptoms were obseved.

Applicant's summary and conclusion

Interpretation of results:
other: not sensitizing
Conclusions:
According to EEC (European Economie Community) and CLP classification criteria described in guidelines 83/467, September 16, 1983, the tested substance is not a sensitizer.
Executive summary:

The purpose of this skin sensitization study was to assess the allergenic potential of the tested substance when administered to the skin of albino guinea pigs following OECD 406, Maximization-Test of B. Magnusson and A.M. Kligman (1969).

No skin reactions were observed in the test group and the tested substance could be considered as not skin sensitizer.