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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Skin sensitisation

Currently viewing:

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
No data available, ECHA provided study summaries migrated from the SNIF format.
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed
Year:
1991

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Annex V (Maximisation)
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
An LLNA skin sensitisation study does not need to be conducted because adequate data from an in vivo skin sensitisation study conducted before 24 April 2002 is available.

Test material

Constituent 1
Chemical structure
Reference substance name:
3,3'-dioctadecyl-1,1'-methylenebis(4,1-phenylene)diurea
EC Number:
406-690-3
EC Name:
3,3'-dioctadecyl-1,1'-methylenebis(4,1-phenylene)diurea
Cas Number:
43136-14-7
Molecular formula:
C51H88N4O2
IUPAC Name:
3-octadecyl-1-[4-({4-[(octadecylcarbamoyl)amino]phenyl}methyl)phenyl]urea
Test material form:
other: No data available, ECHA provided study summaries migrated from the SNIF format.
Details on test material:
No data available, ECHA provided study summaries migrated from the SNIF format.

In vivo test system

Test animals

Species:
other: Guinea pig (Himalayan spotted)

Study design: in vivo (non-LLNA)

No. of animals per dose:
Number of animals in test group: 20
Number of animals in negative control group: 10
Details on study design:
Concentration of test material and vehicle used at induction:
Intradermal: 1% w/w in ethanol
Topical: 15% w/w in vaseline
Concentration of test material and vehicle used for each challenge:
Topical: 0% w/w in vaseline
Topical: 10% w/w in vaseline

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
10%
No. with + reactions:
0
Total no. in group:
20
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
0%
No. with + reactions:
0
Total no. in group:
20
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
10%
No. with + reactions:
0
Total no. in group:
20
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0%
No. with + reactions:
0
Total no. in group:
20
Reading:
rechallenge
Hours after challenge:
24
Group:
test chemical
Dose level:
5%
No. with + reactions:
0
Total no. in group:
20
Reading:
rechallenge
Hours after challenge:
24
Group:
test chemical
Dose level:
10%
No. with + reactions:
0
Total no. in group:
20
Reading:
rechallenge
Hours after challenge:
24
Group:
test chemical
Dose level:
0%
No. with + reactions:
0
Total no. in group:
20
Reading:
rechallenge
Hours after challenge:
48
Group:
test chemical
Dose level:
10%
No. with + reactions:
0
Total no. in group:
20
Reading:
rechallenge
Hours after challenge:
48
Group:
test chemical
Dose level:
0%
No. with + reactions:
0
Total no. in group:
20
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
10%
No. with + reactions:
0
Total no. in group:
10
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0%
No. with + reactions:
0
Total no. in group:
10
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
10%
No. with + reactions:
0
Total no. in group:
10
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0%
No. with + reactions:
0
Total no. in group:
10
Reading:
rechallenge
Hours after challenge:
24
Group:
negative control
Dose level:
0%
No. with + reactions:
0
Total no. in group:
10
Reading:
rechallenge
Hours after challenge:
48
Group:
negative control
Dose level:
0%
No. with + reactions:
0
Total no. in group:
10
Reading:
other: Positive control
Group:
positive control
Dose level:
Not specified
Remarks on result:
other: Positive control not specified

Any other information on results incl. tables

Maximum concentration not causing irritating effects in preliminary test: 10 % Signs of irritation during induction: Very slight erythema (grade 1) was recorded in 2 test animals 24 hours after topical application. Evidence of sensitisation of each challenge concentration: None.

Applicant's summary and conclusion

Interpretation of results:
other: not classified