Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: ECHA diss. Dossier: GLP guideline study; documentation sufficient for assessment

Data source

Reference
Reference Type:
other: ECHA diss. Dossier
Title:
Skin sensitisation
Year:
1993
Report date:
1993

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
LLNA was not established when the skin sensitization test was conducted

Test material

Constituent 1
Reference substance name:
(N-phenylcarbamimidoyl)ammonium carbonate
EC Number:
613-106-2
Cas Number:
6291-89-0
IUPAC Name:
(N-phenylcarbamimidoyl)ammonium carbonate

In vivo test system

Test animals

Species:
guinea pig
Strain:
Pirbright-Hartley
Sex:
male/female

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
physiological saline
Concentration / amount:
1 %, 0.1 mL per injection
Route:
other: epicutaneous
Vehicle:
other: vaseline
Concentration / amount:
50 %, 0.4 g paste per patch
Challenge
No.:
#1
Route:
other: epicutaneous
Vehicle:
other: vaseline
Concentration / amount:
50 %, 0.2 g paste per patch
No. of animals per dose:
test group: 20
control group: 10

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
rechallenge
Hours after challenge:
24
Group:
test chemical
Dose level:
0.2 g
No. with + reactions:
7
Total no. in group:
20
Clinical observations:
slight to well defined erythema, very slight edema
Reading:
rechallenge
Hours after challenge:
48
Group:
test chemical
Dose level:
0.2 g
No. with + reactions:
11
Total no. in group:
20
Clinical observations:
slight to well defined erythema, very slight edema
Reading:
rechallenge
Hours after challenge:
24
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
20
Reading:
rechallenge
Hours after challenge:
48
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
20

Applicant's summary and conclusion

Interpretation of results:
Category 1 (skin sensitising) based on GHS criteria