Registration Dossier
Registration Dossier
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EC number: 701-204-9 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 6AUG1985 - 4NOV1985
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The GLP study was conducted in accordance with a recognised guideline and with sufficient detail to assess the quality of the data.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- Animals were abraded
- GLP compliance:
- yes
Test material
- Reference substance name:
- Reaction products of fatty acids, C14-C18 (branched and linear) and C18 (unsaturated) with tetraethylenepentamine (linear, branched, cyclic)
- EC Number:
- 701-204-9
- Cas Number:
- 68784-17-8
- IUPAC Name:
- Reaction products of fatty acids, C14-C18 (branched and linear) and C18 (unsaturated) with tetraethylenepentamine (linear, branched, cyclic)
- Test material form:
- liquid: viscous
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: LIT Rabbitry, Whitehall, Montana
- Age at study initiation: 21-23 weeks
- Weight at study initiation: data not available
- Housing: individually
- Diet (e.g. ad libitum): Purina Laboratory Rabbit Chow - ad lib
- Water (e.g. ad libitum): ad lib
- Acclimation period: 13 weeks
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22.2 - 22.5 C
- Humidity (%): 36.3-45.3%
- Air changes (per hr): data not available
- Photoperiod (hrs dark / hrs light): 12 hour light/dark
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5ml (neat)
VEHICLE
- no vehicle - Duration of treatment / exposure:
- 4 hour exposure period
- Observation period:
- Irritation was scored at 1, 24, 48, and 72 hours after removal of the test material and at 7 and 14 days.
- Number of animals:
- 6 animals - female
- Details on study design:
- TEST SITE
- Area of exposure: 1 square inch
- % coverage: not data available
- Type of wrap if used: gauze patch secured with porous tape
REMOVAL OF TEST SUBSTANCE
- Washing (if done): gauze pads with mineral oil
- Time after start of exposure: 4 hours
SCORING SYSTEM: Draize
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2.6
- Max. score:
- 2.8
- Reversibility:
- not fully reversible within: 14 days
- Remarks on result:
- other: Intact
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.77
- Max. score:
- 0.9
- Reversibility:
- fully reversible
- Remarks:
- 7 days
- Remarks on result:
- other: Intact
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2.6
- Max. score:
- 2.8
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: Abraded
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.1
- Max. score:
- 2.7
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: Abraded
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant)
- Conclusions:
- Under the conditions of this study, EC 701-204-9 is classified as a Category 2 skin irritant in accordance with Regulation (EC) No 1272/2008.
- Executive summary:
The primary irritation score for the test material in this study was 3.1
The test material caused light to moderate erythema with no to moderate edema at all sites one hour after unwrapping. All sites showed well defined to severe erythema with no to moderate edema 24 hours after dosing, decreasing slightly by the 72 hour scoring. Seven days after dosing, almost all sites had slight to well defined erythema with flaky, discolored, or slightly hardened skin. By the 14 day reading, slight erythema was observed at the two sites. Flaky or thickened skin was seen at almost all sites.
Histopathological examination of the skin sections taken at sacrifice showed trace to mild hyperkertosis, epidermal crusting, and dermal inflammation at almost all sites; trace to mild acanthosis was seen at two sites.
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