Registration Dossier
Registration Dossier
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EC number: 259-839-8 | CAS number: 55819-71-1
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 12 Dec - 21 Dec 2000
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP - guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- adopted July 17, 1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- adopted July 31, 1992
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Federal Office of Public Health, Bern, Switzerland
Test material
- Reference substance name:
- DL-serinohydrazide monohydrochloride
- EC Number:
- 259-839-8
- EC Name:
- DL-serinohydrazide monohydrochloride
- Cas Number:
- 55819-71-1
- Molecular formula:
- C3H9N3O2.ClH
- IUPAC Name:
- 2-amino-3-hydroxy-propanehydrazide;hydrochloride
- Details on test material:
- - Name of test material: DL-SERINE HYDRAZIDE HCL
- Physical state: whitish solid
- Storage condition of test material: in original container, in the refrigerator (range of 4 ± 3 °C), away from direct sunlight, under nitrogen
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Elevage Scientifique des Dombes, Chatillon sur Chalaronne, France
- Age at study initiation: 11 weeks
- Weight at study initiation: 2.2 to 2.3 kg
- Housing: individually in stainless steel cages equipped with feed hoppers, drinking water bowels, with autoclaved wood and haysticks for gnawing
- Diet: pelleted standard Provimi Kliba 3418 rabbit maintenance diet, provided by Provimi Kliba AG, Kaiseraugst, Switzerland; ad libitum; Haysticks provided by Eberle Nafag Ag, Gossau, Switzerland
- Water: community tap water from Füllinsdorf; ad libitum
- Acclimation period: six days under laboratory conditions after health examination.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.5 to 21.5
- Humidity (%): 40 to 66
- Air changes (per hr): 10 to 15
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 g
- test item was moistened with 0.1 mL bi-distilled water before application - Duration of treatment / exposure:
- 4 h
- Observation period:
- 72 h
reading time points: 1, 24, 48, 72 h - Number of animals:
- 1 male and 2 females
- Details on study design:
- TEST SITE
- Area of exposure: 6 cm² on the left flank
- Type of wrap if used: patch was coverd with semi-occlusive dressing (Isoelast Heftpflaster Acryl 8 x 75 cm). The dressing was wrapped around the abdomen and anchored with tape.
REMOVAL OF TEST SUBSTANCE
- Washing: residual test item was removed by flushing the skin with lukewarm tap water
- Time after start of exposure: dressing was removed at the end of the treatment period (4 h)
SCORING SYSTEM:
The skin reaction was assessed according to the numerical scoring system listed in the EEC Commission Directive 92/60/EEC, July 31, 1992.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- Throughout the observation period starting with reading time point of one hour, no irreversible alterations of the treated skin were observed nor were corrosive effects evident on the skin.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classified
DSD: not classified
The test item is considered to be "non irritating" to rabbit skin based on the classificatoin criteria according to EEC Commission Directive 93/21/EEC of April 27th, 1993. - Executive summary:
To assess the primary skin irritation of the test item, a primary skin irritation study was performed in one male and two female young adult New Zealand White rabbits.
The fur of the left flank was clipped and 0.5 g of the test item was applied epicutaneously to an area of approximately 6 cm². The area was then covered with a semi-occlusive dressing for approximately four hours. After the dressing and test item had been removed, the skin reactions (erythema, eschar and oedema formation) were evaluated at 1, 24, 48 and 72 hours after application. The primary irritation score was calculated to reflect and classify the irritant potential of the test item.
The dermal exposure to the test item did not elicit any skin reactions at the application site of any animal at any time point of the observation period. The mean values from 24 to 72 hours were therefore "0" for erythema as well as for oedema.
Following the evaluation of the experimental data according to CLP/DSD classification criteria, the test item is classified as "not irritating" to rabbit skin.
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