Registration Dossier
Registration Dossier
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EC number: 251-908-0 | CAS number: 34274-28-7
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 31.03.1995 to 03.04.1995
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- [nitrilotris(methylene)]trisphosphonic acid, ammonium salt
- EC Number:
- 251-908-0
- EC Name:
- [nitrilotris(methylene)]trisphosphonic acid, ammonium salt
- Cas Number:
- 34274-28-7
- Molecular formula:
- C3H12NO9P3.xH3N
- IUPAC Name:
- ammonium hydrogen {[bis(phosphonomethyl)amino]methyl}phosphonate
- Test material form:
- liquid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: David Percival Ltd., Moston, Sandbach, Cheshire, UK.
- Age at study initiation: 12 to 16 weeks
- Weight at study initiation: 2.3 to 2.61 kg
- Housing: Individually housed in suspended metal cages.
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: Minimum five days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-21
- Humidity (%): 56-61
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 31.03.1995 To: 03.04.1995
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml - Duration of treatment / exposure:
- Four hours
- Observation period:
- 72 hours
- Number of animals:
- Three
- Details on study design:
- TEST SITE
- Area of exposure: The back
- % coverage: No stated, but patch was 2.5 x 2.5
- Type of wrap if used: The trunk was wrapped in an elasticated corset.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes, with cotton wool soaked in distilled water
- Time after start of exposure: Four hours
SCORING SYSTEM: Draize
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: all
- Score:
- 0
- Reversibility:
- other: No irritation observed
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No dermal reactions observed.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In a GLP, skin irritation study (reliability score 1) conducted to OECD 404, undiluted ammonium salt of ATMP (no information on composition of liquid tested) was not irritating to the skin of rabbits.
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