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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Remarks:
in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1988
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
The robust study summary was received from the ECHA in accordance with Article 25(3) (the "12-year-rule"). ECHA helpdesk enquiry number: 06-0000024807-62-0000. The full study report is not available. The test was performed according to Directive 67/548/EEC requirements and GLP.

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed
Year:
1988
Report date:
1988

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Annex V
GLP compliance:
yes
Type of study:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
402-130-7
EC Name:
-
Cas Number:
106246-33-7
Molecular formula:
C21 H28 Cl2 N2
IUPAC Name:
4-[(4-amino-2-chloro-3,5-diethylphenyl)methyl]-3-chloro-2,6-diethylaniline

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley

Study design: in vivo (non-LLNA)

Induction
Concentration / amount:
Concentration of test material and vehicle used at induction:10w7v in paraffin oil for both stages.
Concentration of test material and vehicle used for each challenge: 25% in paraffin oil
Challenge
Concentration / amount:
Concentration of test material and vehicle used at induction:10w7v in paraffin oil for both stages.
Concentration of test material and vehicle used for each challenge: 25% in paraffin oil
No. of animals per dose:
Number of animals in test group: 20
Number of animals in negative control group: 20

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
25%
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: 25%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
25%
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: 25%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
25%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
25%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 20.0.

Any other information on results incl. tables

Signsof irritation during induction: Slight to moderate /Grade 1 and 2) reactions in test group, slight in control group.

Evidence of sensitization of each challenge concentration: None

Applicant's summary and conclusion

Interpretation of results:
other: not classified