Registration Dossier
Registration Dossier
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EC number: 700-169-7 | CAS number: 7646-67-5
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 27 September 1999 to 22 October 1999
- 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 guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- N-(2-hydroxyethyl)prop-2-enamide
- EC Number:
- 700-169-7
- Cas Number:
- 7646-67-5
- Molecular formula:
- C5H9NO2
- IUPAC Name:
- N-(2-hydroxyethyl)prop-2-enamide
Constituent 1
- Specific details on test material used for the study:
- Batch number: not advised
Purity: >99%
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River, Margate, Kent, England
- Age at study initiation: At least 12 weeks
- Weight at study initiation: 2.4 to 2.8 kg
- Housing: Individual stainlees steel cages with perforated floors.
- Diet (e.g. ad libitum): Special diet services, STANRAB (P) SQC pellet
- Water : ad libitum
- Acclimation period: 13 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 to 19°C
- Humidity (%): 31 to 58%
- Air changes (per hr): unknown
- Photoperiod (hrs dark / hrs light): 12 hours dark / 12 hours light
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml on 25 mm x 25 mm area
VEHICLE
- Amount(s) applied (volume or weight with unit): none - Duration of treatment / exposure:
- 4 hours
- Observation period:
- Day 1 approximately 60 minutes after removal of the dressings, days 2, 3 and 4.
- Number of animals:
- 3 males
- Details on study design:
- TEST SITE
- Area of exposure: 25 mm x 25 mm
- % coverage: 100%
- Type of wrap if used: Semi-occlusive pad and gauze dressing.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Treatment site washed with warm water, at 38°C, to remove any residual test substance.
- Time after start of exposure: 4 hours.
SCORING SYSTEM: A primary Irritation index (PII) was calculated from the erythema and oedema scores according to the formula sa described in Technical Report No. 66"Skin irritation and corrosion: Reference chemicals data bank" (March 1995) ECTETOC, Brussels.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritant / corrosive response data:
- No dermal irritation was observed following a single semi-occlusive application of HEAA to intact rabbit skin for four hours.
- Other effects:
- There were no signs of toxicity or ill health in any rabbit during the observation period.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- A single semi-occlusive application of HEAA to intact rabbit skin for four hours elicited no dermal irritation and HEAA is classified as a non-irritant.
- Executive summary:
The study was performed to assess the skin irritation potential of HEAA to the rabbit, according to OECD Guideline 404, under GLP.
A single semi-occlusive application of HEAA to intact rabbit skin for four hours elicited no dermal irritation and HEAA is classified as a non-irritant.
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