Registration Dossier
Registration Dossier
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EC number: 418-370-0 | CAS number: 143925-92-2
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1995-06-06 to 1995-09-20
- 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 guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 24 February 1987
- Deviations:
- yes
- Remarks:
- Occlusive treatment was used. This has no impact on the realibility of the study.
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- 31 July 1992
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 418-370-0
- EC Name:
- -
- Cas Number:
- 143925-92-2
- Molecular formula:
- C32-36 H67-74 N1 O1
- IUPAC Name:
- N-hexadecyl-N-octadecylhydroxylamine
- Test material form:
- solid
- Details on test material:
- - State of aggregation: solid
1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Dr. K. Thomae GMBH; Chemisch-pharmazeutische Fabrik; D-88397 Biberach
- Age at study initiation: 2 to 3 month
- Weight at study initiation: 2410 to 2500 g
- Housing: individually in metal cages
- Diet: standard rabbit pellet - Nafag No. 814, Gossau, Switzerland, ad libitum
- Water: fresh water ad libitum
- Acclimation period:at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 2 0 ± 3 °C
- Humidity: relative humidity of 30-70 %
- Air changes (per hr): not stated
- Photoperiod: 12 hours light cycle day.
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- other: 0.5 % (w/v) carboxymethylcellulose in 0.1 % (w/v) aqueous polysorbate 80
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.5 g
VEHICLE
- Amount(s) applied: patches were moistened with the vehicle - Duration of treatment / exposure:
- 4 hours
- Observation period:
- - 72 hours; extended to 7 days
- skin reactions were evaluated 1, 24, 48, and 72 hours after removing the gauze patches - Number of animals:
- 3 males
- Details on study design:
- TEST SITE
- Area of exposure: 12 - 16 cm² at the flank of the animals
- Type of wrap: patch covered with aluminium foil and hold in place with adhesive plast (Isoplast) wrapping
REMOVAL OF TEST SUBSTANCE
- Washing: none
SCORING SYSTEM: OECD guideline No. 404
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- Slight erythema (score 1) was recorded in all rabbits 1 and 24 hours after gauze patch removal and in one animal up to 72 hours.
Because reactions were observed within 3 days after removing the bandages, the observation period was extended to 7 days to determine the reversibility of the skin reactions. On day 7, skin reactions were fully reversed in all animals.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item caused minimal irritation below the threshold of significance and is therefore considered to be not irritating.
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