Registration Dossier
Registration Dossier
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EC number: 701-068-0 | CAS number: 2156592-58-2
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
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:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Amines, coco alkyl
- EC Number:
- 262-977-1
- EC Name:
- Amines, coco alkyl
- Cas Number:
- 61788-46-3
- IUPAC Name:
- 61788-46-3
- Reference substance name:
- Coco Alkylamines
- IUPAC Name:
- Coco Alkylamines
- Details on test material:
- - Name of test material (as cited in study report): Genamin CC 100 D
Constituent 1
Constituent 2
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: HOECHST AG, Kastengrund, conventional breed
- Age at study initiation: about 3 -5 months
- Weight at study initiation: 2.4 - 2.8 kg
- Housing: fully air-conditioned rooms, individual cages.
- Diet (e.g. ad libitum): ad libitum (Altromin 2123, Altromin GmbH (Lage/Lippe))
- Water (e.g. ad libitum): ad libitum (deionised, chlorinated water)
- Acclimation period:
- min. 7 days
- daily observation during acclimation period
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +-3 °C
- Humidity (%): 50 +-20 %
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL - Duration of treatment / exposure:
- 3 min (3 animals)
1 h (3 animals)
Then test substance was removed cautiously from the skin with warm tap-water - Observation period:
- 30-60 min
24 / 48 / 72 hrs
7 / 14 / 21 days - Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- % coverage: 100 %
0.5mL of the test substance was applied over the whole surface of a 2.5 x 2.5 cm cellulose patch on a piece of surgical plater (specially produced by Beiersdorf AG, Hamburg. The plaster was fixed to the prepared skinarea (ca. 25 cm2) and then covered with a semi-occlusive bandage
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with warm tap water
- Time after start of exposure: 3 min (3 animals); 1h(3 animals)
SCORING SYSTEM:
Erythema and eschar formation
No erythema.......................................................................................................................0
very slight erythema (barely perceptible)......................................................................1
well-defined erythema......................................................................................................2
moderate to severe erythema..........................................................................................3
severe erythema (beet redness) to slight eschar formation (lesion in depth).........4
Oedema
No oedema...................................................................................................................................0
very slight oedema (barely perceptible)..................................................................................1
slight oedema (edges of area well defined by definite raising)............................................2
moderate oedema (raised approximately 1mm)....................................................................3
severe oedema (raised more than 1mm and extending beyond area of exposure.........4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Remarks:
- overall
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- other: 24h / 48h / 72h
- Score:
- 1.9
- Max. score:
- 3
- Reversibility:
- other: scare formation after 21 days
- Remarks on result:
- other: exposure 3 minutes
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- mean
- Time point:
- other: 24h / 48h / 72h
- Score:
- 2.7
- Max. score:
- 3
- Reversibility:
- other: scare formation after 21 days
- Remarks on result:
- other: exposure 3 minutes
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- mean
- Time point:
- other: 24h / 48h / 72h
- Score:
- 1.7
- Max. score:
- 2
- Reversibility:
- other: scare formation after 21 days
- Remarks on result:
- other: exposure 3 minutes
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- mean
- Time point:
- other: 24h / 48h / 72h
- Score:
- 1.33
- Max. score:
- 2
- Reversibility:
- other: scare formation after 21 days
- Remarks on result:
- other: exposure 3 minutes
- Irritation parameter:
- edema score
- Remarks:
- overall
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- other: 24h / 48h / 72h
- Score:
- 1.7
- Max. score:
- 3
- Reversibility:
- other: scare formation after 21 days
- Remarks on result:
- other: exposure 3 minutes
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- mean
- Time point:
- other: 24h / 48h / 72h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- other: scare formation after 21 days
- Remarks on result:
- other: exposure 3 minutes
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- mean
- Time point:
- other: 24h / 48h / 72h
- Score:
- 1.3
- Max. score:
- 2
- Reversibility:
- other: scare formation after 21 days
- Remarks on result:
- other: exposure 3 minutes
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- mean
- Time point:
- other: 24h / 48h / 72h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- other: scare formation after 21 days
- Remarks on result:
- other: exposure 3 minutes
- Irritation parameter:
- erythema score
- Remarks:
- overall
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- other: 24h / 48h / 72h
- Score:
- 1.77
- Max. score:
- 3
- Reversibility:
- other: scare formation after 14 - 21 days
- Remarks on result:
- other: exposure 60 minutes
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- mean
- Time point:
- other: 24h / 48h / 72h
- Score:
- 1.77
- Max. score:
- 2
- Reversibility:
- other: scare formation after 21 days
- Remarks on result:
- other: exposure 60 minutes
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- mean
- Time point:
- other: 24h / 48h / 72h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- other: scare formation after 21 days
- Remarks on result:
- other: exposure 60 minutes
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- mean
- Time point:
- other: 24h / 48h / 72h
- Score:
- 2.67
- Max. score:
- 3
- Reversibility:
- other: scare formation after 14 days
- Remarks on result:
- other: exposure 60 minutes
- Irritation parameter:
- edema score
- Remarks:
- overall
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- other: 24h / 48h / 72h
- Score:
- 1.33
- Max. score:
- 3
- Reversibility:
- other: scare formation after 14 - 21 days
- Remarks on result:
- other: exposure 60 minutes
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- mean
- Time point:
- other: 24h / 48h / 72h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- other: scare formation after 21 days
- Remarks on result:
- other: exposure 60 minutes
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- mean
- Time point:
- other: 24h / 48h / 72h
- Score:
- 1.67
- Max. score:
- 3
- Reversibility:
- other: scare formation after 21 days
- Remarks on result:
- other: exposure 60 minutes
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- mean
- Time point:
- other: 24h / 48h / 72h
- Score:
- 1.33
- Max. score:
- 2
- Reversibility:
- other: scare formation after 14 days
- Remarks on result:
- other: exposure 60 minutes
Applicant's summary and conclusion
- Interpretation of results:
- highly corrosive
- Remarks:
- Migrated information Criteria used for interpretation of results: expert judgment
- Conclusions:
- Based on the study report and the criteria laid down in the Directive 83/467/EEC, Genamin CC 100 D has to be labelled as corrosive (C) with the designation R35 - causes severe burns.
- Executive summary:
Severe erythema and moderate edema were observed for three minute exposure and one hour exposure time. After 24hrs following removal of the patches the skin was hardened, lumpy and discolored from light-brown to brown/black. The treated area was sharply confined to the untreated skin and in case of the animals with one hour exposure time circumvented with a white rim. From 7 days after removal of the patches, desquamation of coarse scales occurred and in some cases open wounds and 14 to 21 days after removal of the patches eschar formation was observed. The newly build skin was pergament-like, pink and scarred.
Based on the study report and the criteria laid down in the Directive 83/467/EEC, Genamin CC 100 D has to be labelled as corrosive (C) with the designation R35 - causes severe burns.
3 min-exposure:
Time after removal of the patch 30 - 60 min 24 h 48 h 72 h 7 d 14 d 21 d Animal 1 2 3 1 2 3 1 2 3 1 2 3 1 2 3 1 2 3 1 2 3 erythema and eschar formation 2 4 1 3 1 1 3 2 1 2 2 2 0 1 0 1 0 0 0 0 0 edema 1 1 1 3 2 3 2 1 2 1 1 1 0 0 0 0 0 0 0 0 0 1h-exposure:
Time after removal of the patch 30 - 60 min 24 h 48 h 72 h 7 d 14 d 21 d Animal 1 2 3 1 2 3 1 2 3 1 2 3 1 2 3 1 2 3 1 2 3 erythema and eschar formation 2 1 2 2 1 3 2 1 3 1 1 2 2 1 1 1 2 0 0 0 0 edema 1 1 1 2 3 2 1 1 1 0 1 1 0 0 0 0 1 0 0 0 0 see attached study report 84.0921 for further details
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