Registration Dossier
Registration Dossier
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EC number: 401-950-2 | CAS number: 31506-43-1 3-(DIMETHYLAMINO)PROPYL UREA; HST 2844
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2000
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- This study was designed to comply with the standards set forth in 49 CFR 173.137 which directs that this study be conducted according to the July 1992 OECD Guideline for Testing of Chemicals, Number 404, "Acute Dermal InitationlCorrosionn.
- GLP compliance:
- yes
Test material
- Reference substance name:
- 3-(dimethylamino)propylurea
- EC Number:
- 401-950-2
- EC Name:
- 3-(dimethylamino)propylurea
- Cas Number:
- 31506-43-1
- Molecular formula:
- C6H15N3O
- IUPAC Name:
- [3-(dimethylamino)propyl]urea
- Reference substance name:
- Oxydipropanol
- EC Number:
- 246-770-3
- EC Name:
- Oxydipropanol
- Cas Number:
- 25265-71-8
- Molecular formula:
- C6H14O3
- IUPAC Name:
- 1,1'-oxydipropan-1-ol
- Reference substance name:
- 1,3-bis[3-(dimethylamino)propyl]urea
- EC Number:
- 257-861-2
- EC Name:
- 1,3-bis[3-(dimethylamino)propyl]urea
- Cas Number:
- 52338-87-1
- Molecular formula:
- C11H26N4O
- IUPAC Name:
- 1,3-bis[3-(dimethylamino)propyl]urea
- Reference substance name:
- Urea
- EC Number:
- 200-315-5
- EC Name:
- Urea
- Cas Number:
- 57-13-6
- Molecular formula:
- CH4N2O
- IUPAC Name:
- urea
- Test material form:
- liquid
Constituent 1
Constituent 2
Constituent 3
Constituent 4
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Duration of treatment / exposure:
- The test article was kept in contact with the skin for three (3) minutes and scored for erythema and edema one hour following patch removal. Since the 3 minute exposure did not produce a definitive effect, two additional rabbits were added to the study. All three animals were dosed at site #2 for an exposure period of 1 hour and at site #3 for a four hour exposure. Each site was scored for erythema and edema one hour following patch removal, at 24, 48 and 72 hours and again on days 7 and 14.
- Observation period:
- Animals were observed for systemic signs at each dermal scoring interval.
- Number of animals:
- 3 New Zealand White rabbits
- Details on study design:
- New Zealand White rabbits were received from Ace Animals, Boyertown, PA on 12/21/99. Following a quarantine period of at least one week, three healthy New Zealand White rabbits were selected for this test from a larger group.
The animals were born the weeks of 10/10 through 10/24/99. The pretest body weight was 2.0 kg. The animals were identified by cage notation and a uniquely numbered metal eartag. The animals were housed llcage in suspended cages. Bedding was placed beneath the cages and changed at least three timeslweek. Fresh Purina Rabbit Chow (Diet #5321) was provided daily. Water was available libitum.
The animal room, reserved exclusively for rabbits on acute tests, was temperature controlled, had a 12 hour lightidark cycle and was kept clean and vermin free.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritant / corrosive response data:
- 3 minute exposure: There was no erythema or edema.
1 hour exposure: There was no erythema or edema.
4 hour exposure: There was no erythema or edema. - Other effects:
- Two animals had diarrhea and soiling of the anogenital area. The remaining animal appeared normal during the observation period. Body weight changes were normal.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- NE 1060 is not corrosive to rabbit skin. The modified Primarv Irritation Index is 0.
- Executive summary:
The purpose of this study was to determine if the test article causes irreversible damage when applied to the rabbit skin.
Initially, one healthy New Zealand White rabbit was placed in a restrainer and dosed with NE 1060. The test article (0.5 ml) was placed on the intact skin of the back (Site 1). The test article was kept in contact
with the skin for three (3) minutes and scored for erythema and edema one hour following patch removal. Since the 3 minute exposure did not produce a definitive effect, two additional rabbits were added to the
study. All three animals were dosed at Site 2 for an exposure period of 1 hour and at Site 3 for a four hour exposure. Each site was scored for erythema and edema one hour following patch removal, at 24, 48, and 72 hours and again on Days 7 and 14. Animals were observed for systemic signs at each dermal scoring interval. A modified primary irritation index was calculated. Body weights were recorded pretest and at termination.
3 minute exposure: There was no erythema or edema.
1 hour exposure: There was no erythema or edema.
4 hour exposure: There was no erythema or edema.
Systemic observations: Two animals had diarrhea and soiling of the anogenital area. The remaining animal appeared normal during the observation period. Body weight changes were normal.
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