Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline used simillar to the guideline of today.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report date:
1979

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: US Department of Agriculture (Fed Reg 38, 187, 27019, 1973)
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Aminoguanidinium hydrogen carbonate
EC Number:
219-956-7
EC Name:
Aminoguanidinium hydrogen carbonate
Cas Number:
2582-30-1
Molecular formula:
CH6N4.CH2O3
IUPAC Name:
N-aminoguanidine; carbonic acid
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
content 99 %

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 3-4 kg
- Housing: singly
- Diet ad libitum
- Water ad libitum
standard conditions

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: shorn: intact and scarificed
Vehicle:
unchanged (no vehicle)
Controls:
other: the opposite site served as control
Amount / concentration applied:
no details given
Duration of treatment / exposure:
24 hours
Observation period:
72 hours
Number of animals:
4
Details on study design:
According to the US Department of Agriculture (Fed Reg. 38, 187, 27019, 1973).

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: avg 24, 48, 72 h
Score:
0
Remarks on result:
other: intact or scarificed skin of rabbits
Irritant / corrosive response data:
No irritation effects were observed

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information
Executive summary:

Aminoguanidinium hydrogen carbonate was investigated for skin irritating property in rabbits using a guideline given by the U.S. Department of Agriculture (Fed. Reg 38, 187, 27019, 1973).

Aminoguanidinium hydrogen carbonate caused no irritation in the skin of rabbits.