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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

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

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
other:
Title:
Unnamed
Year:
2011

Materials and methods

Test guideline
Guideline:
other: Maximization Test according to Magnusson and Kligman (J. Invest. Dermatol. 52, 268-276, 1969) and recommended in the OECD-guideline Nr. 406, 12.5.81
GLP compliance:
not specified
Remarks:
Not provided in information from NONS file (Corrigendum INQ-C-0000001810-82-01), as per inquiry number 06-0000021186-73-0000, permission to refer granted by ECHA.
Type of study:
guinea pig maximisation test

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
401-540-3
EC Name:
-
Cas Number:
84632-65-5
Molecular formula:
C18H10Cl2N2O2
IUPAC Name:
3,6-bis(4-chlorophenyl)-1H,2H,4H,5H-pyrrolo[3,4-c]pyrrole-1,4-dione

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Pirbright White Strain
Sex:
male/female

Study design: in vivo (non-LLNA)

Induction
Concentration / amount:
ConcentratIon in the induction period:
1% in sesame oil and adjuvant mixture(intradermal application);
10% in vaseline(epidermal application).

Concentration in the challenge period:
0.3% in vaseline.
Challenge
Concentration / amount:
ConcentratIon in the induction period:
1% in sesame oil and adjuvant mixture(intradermal application);
10% in vaseline(epidermal application).

Concentration in the challenge period:
0.3% in vaseline.
No. of animals per dose:
20 (10 males and 10 females)

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
1%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 1%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
1%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 1%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
10%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 10%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
10%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 10%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 10.0.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information