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Diss Factsheets

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: data from ELINCS notification dossier approved by MSCA

Data source

Reference
Reference Type:
other: Boda responsibkle for the test
Title:
Unnamed
Year:
1997
Report date:
1997

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Directive 92/69/EEC, B.6
GLP compliance:
yes
Type of study:
guinea pig maximisation test

Test material

Constituent 1
Chemical structure
Reference substance name:
1-phenyl-3-(p-toluenesulfonyl)urea
EC Number:
424-620-1
EC Name:
1-phenyl-3-(p-toluenesulfonyl)urea
Cas Number:
13909-63-2
Molecular formula:
C14H14N2O3S
IUPAC Name:
3-(4-methylbenzenesulfonyl)-1-phenylurea

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Albino, Dunkin-Hartley

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
other: intradermal and topical
Concentration / amount:
Concentration of test material and vehicle used at induction:
a) Intradermal Induction: 25 % (w/v) in arachis oil B.P.
25 % (w/v) in Freund's Complete Adjuvant/ aqua dest. 1:1
b) Topical Induction: 50 % (w/w) in arachis oil B.P.

Concentration of test material and vehicle used for each challenge:
a) 50 % (w/w) in arachis oil B.P.
b) 25 % (w/w) in arachis oil B.P.
Challenge
Concentration / amount:
Concentration of test material and vehicle used at induction:
a) Intradermal Induction: 25 % (w/v) in arachis oil B.P.
25 % (w/v) in Freund's Complete Adjuvant/ aqua dest. 1:1
b) Topical Induction: 50 % (w/w) in arachis oil B.P.

Concentration of test material and vehicle used for each challenge:
a) 50 % (w/w) in arachis oil B.P.
b) 25 % (w/w) in arachis oil B.P.
No. of animals per dose:
Number of animals in test group: 10
Number of animals in negative control group: 5

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:
10
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: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
10 %
No. with + reactions:
0
Total no. in group:
10
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: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
25 %
No. with + reactions:
0
Total no. in group:
10
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: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
10 %
No. with + reactions:
0
Total no. in group:
10
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: 10.0.
Reading:
1st reading
Hours after challenge:
14
Group:
negative control
Dose level:
25 %
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 14.0. Group: negative control. Dose level: 25 %. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
1st reading
Hours after challenge:
14
Group:
negative control
Dose level:
10 %
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 14.0. Group: negative control. Dose level: 10 %. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
25 %
No. with + reactions:
0
Total no. in group:
5
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: 5.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
10 %
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 10 %. No with. + reactions: 0.0. Total no. in groups: 5.0.

Any other information on results incl. tables

Maximum concentration not causing irritating effects in preliminary test: 50 %

Signs of irritation during induction:

intradermal:

Very slight to well defined erythema was noted at the intradermal induction sites of all test group animals at the 24 h observation and in 9 test group animals at the 48 h observation.

Very slight erythema was noted at the intradermal induction sites of all control group animals at the 24 and 48h observations.

topical:

Test animals:

After 1 h: very slight erythema was noted at the induction sites of 5 test group animals. In one animal bleedings at the intradermal induction spot were observed.

After 24 h: No skin reactions were observed at the induction sites of test group animals.

Controls:

After 1 h: Bleedings at the intradermal induction spot of one animal.

After 24 h: No skin reactions observed.

Evidence of sensitisation of each challenge concentration: 0/10

Other observations:

Body weight gains of animals in the test group, between day 0 and day 24, were comparable to those in the control group.

The body weight gain was not affected.

Applicant's summary and conclusion

Interpretation of results:
other: not classified
Remarks:
Criteria used for interpretation of results: EU