Registration Dossier
Registration Dossier
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EC number: 219-956-7 | CAS number: 2582-30-1
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- 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: guideline study and GLP
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Species:
- guinea pig
- Strain:
- other: HsdWin:DH
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source:
- Age at study initiation: 5-7 weeks
- Weight at study initiation: 316-406 g
- Housing: 2-3 per cage throughout the study
- Diet ad libitum
- Water ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21
- Humidity (%): 40-70
- Air changes (per hr): 12-15
- Photoperiod (hrs dark / hrs light): 12 / 12 - Route:
- intradermal and epicutaneous
- Vehicle:
- physiological saline
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- physiological saline
- No. of animals per dose:
- 20
- Details on study design:
- intradermal induction : 5 %
topical induction 50 %
4 weeks after intradermal induction
first topical challenge 50 and 25 %
second challenge 50 and 25 % - Challenge controls:
- The animal of the control groups were treated in the same manner as the animals of the test substance group; however, the formulations did not contain any test substance but a corresponding amount of sterile physiological saline.
- Positive control substance(s):
- not specified
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50 %
- No. with + reactions:
- 4
- Total no. in group:
- 20
- Clinical observations:
- mild
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50 %. No with. + reactions: 4.0. Total no. in groups: 20.0. Clinical observations: mild.
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 3
- Total no. in group:
- 20
- Clinical observations:
- mild
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 50%. No with. + reactions: 3.0. Total no. in groups: 20.0. Clinical observations: mild.
- Reading:
- other: rechallege 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50 %
- No. with + reactions:
- 14
- Total no. in group:
- 20
- Clinical observations:
- readily visible
- Remarks on result:
- other: Reading: other: rechallege 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50 %. No with. + reactions: 14.0. Total no. in groups: 20.0. Clinical observations: readily visible.
- Reading:
- other: rechallenge 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 9
- Total no. in group:
- 20
- Clinical observations:
- readily visible
- Remarks on result:
- other: Reading: other: rechallenge 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 50%. No with. + reactions: 9.0. Total no. in groups: 20.0. Clinical observations: readily visible.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25 %
- No. with + reactions:
- 8
- Total no. in group:
- 20
- Clinical observations:
- readily visible
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25 %. No with. + reactions: 8.0. Total no. in groups: 20.0. Clinical observations: readily visible.
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 7
- Total no. in group:
- 20
- Clinical observations:
- mild
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 25%. No with. + reactions: 7.0. Total no. in groups: 20.0. Clinical observations: mild.
- Reading:
- other: rechallenge 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25 %
- No. with + reactions:
- 9
- Total no. in group:
- 20
- Clinical observations:
- readily visible
- Remarks on result:
- other: Reading: other: rechallenge 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25 %. No with. + reactions: 9.0. Total no. in groups: 20.0. Clinical observations: readily visible.
- Reading:
- other: rechallenge 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 9
- Total no. in group:
- 20
- Clinical observations:
- readily visible
- Remarks on result:
- other: Reading: other: rechallenge 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 25%. No with. + reactions: 9.0. Total no. in groups: 20.0. Clinical observations: readily visible.
- Reading:
- other: controls
- Group:
- negative control
- Dose level:
- physiological saline
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: other: controls. Group: negative control. Dose level: physiological saline. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information
- Executive summary:
The maximization test of Magnusson and Kligman was performed on male guinea pigs to determine whether aminoguanidinium hydrogen carbonate exhibits skin sensitization properties.
This GLP study was performed according to OECD Guideline No. 406.
The study was conducted with the following test concentrations.
intradermal induction: 5%
topical induction: 50 %
first challenge: 50 and 25 %
second challenge: 50 and 25 %
Aminoguanidinium hydrogen carbonate was formulated in sterile physiological saline solution to yield a suspension.
After the first challenge the 50 % and 25% aminoguanidinium hydrogen carbonate formulations led to skin redness in 20 % and 40 % of the test animals respectively There were no skin reactions in the control group.
After the second challenge the 50 % and 25 % aminoguanidinium hydrogen carbonate formulations led to skin redness in 70 % and 45 % of the test animals, respectively. There were no skin reactions in the control group.
Aminoguanidinium hydrogen carbonate thus exhibits a definitive skin-sensitization potential under the conditions of the maximization test.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
The maximization test of Magnusson and Kligman was performed on male guinea pigs to determine whether aminoguanidinium hydrogen carbonate exhibits skin sensitization properties.
This GLP study was performed according to OECD Guideline No. 406.
The study was conducted with the following test concentrations.
intradermal induction: 5%
topical induction: 50 %
first challenge: 50 and 25 %
second challenge: 50 and 25 %
Aminoguanidinium hydrogen carbonate was formulated in sterile physiological saline solution to yield a suspension.
After the first challenge with 50 % and 25% aminoguanidinium hydrogen carbonate skin redness was recorded in 20 % and 40 % of the test animals, respectively. There were no skin reactions in the control group.
After the second challenge the 50 % and 25 % aminoguanidinium hydrogen carbonate formulations led to skin redness in 70 % and 45 % of the test animals, respectively. There were no skin reactions in the control group.
Aminoguanidinium hydrogen carbonate thus exhibits a skin-sensitization potential under the conditions of the maximization test.
Migrated from Short description of key information:
Aminoguanidinium hydrogen carbonate is a skin sensitizer in the Maximization Test in guinea pigs.
Justification for selection of skin sensitisation endpoint:
Study performed according to the respective guideline and GLP and evaluated with Klimisch score 1.
Justification for classification or non-classification
Based on the available data aminoguanidinium hydrogen carbonate has to be allocated to category 1B of the sensitizing substances according to Regulation 12072 (2008), 2. ATP. With respect to Regualation (EC) 67/548/EWG aminoguanidinium hydrogen carbonate is classified as sensitizer and labelled with R43.
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