Registration Dossier
Registration Dossier
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EC number: 295-714-4 | CAS number: 92128-22-8
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
- Report date:
- 1984
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- - purity of test substance not specified, no individual animal weights recorded
- GLP compliance:
- no
Test material
- Reference substance name:
- Fatty acids, tall-oil, compds. with N-[3-(dimethylamino)propyl]tall-oil amides
- EC Number:
- 295-714-4
- EC Name:
- Fatty acids, tall-oil, compds. with N-[3-(dimethylamino)propyl]tall-oil amides
- Cas Number:
- 92128-22-8
- Molecular formula:
- Not applicable (UVCB substance)
- IUPAC Name:
- Reaction products of tall-oil fatty acids and (3-aminopropyl)dimethylamine
- 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: Hacking & Churchill Ltd. (Huntingdon, U.K.)
- Age at study initiation: not specified
- Weight at study initiation: 3.7 - 3.9 kg
- Housing: individual
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: not specified
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25
- Humidity (%): 40 - 60
- Air changes (per hr): not specified
- Photoperiod (hrs dark / hrs light): 12 / 12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated skin on the opposite flank of each animal served as control
- Amount / concentration applied:
- amount applied: 0.5 ml (undiluted)
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 1, 24, 48, 72 hours and 7, 14 days after removal of patches
- Number of animals:
- 6 (3 males and 3 females)
- Details on study design:
- TEST SITE
- Area of exposure: approx. 2.5 x 2.5 cm
- % coverage: not specified
- Type of wrap if used: gauze patch fixed with an elastic adhesive tape pervious to air
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with water
- Time after start of exposure: approx. 4 hours
SCORING SYSTEM: according to DRAIZE
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: #1,2,3,5,6
- Time point:
- other: 1 hour
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- other: 1 hour
- Score:
- 2
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal: #1-6
- Time point:
- other: 1 hour
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- other: not reversible within 14 days
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
Any other information on results incl. tables
All animals showed induration and encrustation of the application site beginning at 24 hours after removal of patches. Within 7 days there was a detachment of the necrotic skin areas of the application site, partly under formation of fissures. The underlying skin areas appeared smooth and shiny, but were sometimes encrusted. Within the 14-day post observation period no restitution with normal skin findings at the application site were observed.
Applicant's summary and conclusion
- Interpretation of results:
- corrosive
- Remarks:
- Migrated information
- Executive summary:
In a dermal irritation/corrosion test the test substance was corrosive to the skin of rabbits according to OECD TG 404. Within the 14-day post-observation period no restitution with normal skin findings at the application site were observed.
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