Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
eye 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 similiar to the guidelines 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 Health, Education and Welfare : Fed Reg 37 (83), 8535, 1972
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: ca: 99 %

Test animals / tissue source

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

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
no details given
Duration of treatment / exposure:
5 min or 24 hours
Observation period (in vivo):
21 days
Number of animals or in vitro replicates:
4 per exposure period
Details on study design:
According to the US Department of Health, Education and Welfare (Fed Reg 37 (83), 8535, 1972).

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 21 days
Score:
0
Remarks on result:
other: exposure time 5 minutes
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 21 days
Score:
0
Remarks on result:
other: exposure time 24 hours
Irritant / corrosive response data:
no irrtation are observed

Applicant's summary and conclusion

Executive summary:
Aminoguanidinium hydrogen carbonate was investigated for eye irritating property in rabbits using a guideline given by the US Department of Health, Education and Welfare (Fed Reg 37 (83), 8535, 1972).

Aminoguanidinium hydrogen carbonate was not irritating to the eyes of rabbits.