Registration Dossier
Registration Dossier
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EC number: 212-485-8 | CAS number: 822-06-0
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:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
- Report date:
- 1981
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- - type of coverage is occlusive instead of semi-occlusive, post-observation period only 8 days
- GLP compliance:
- no
Test material
- Reference substance name:
- Hexamethylene diisocyanate
- EC Number:
- 212-485-8
- EC Name:
- Hexamethylene diisocyanate
- Cas Number:
- 822-06-0
- Molecular formula:
- C8H12N2O2
- IUPAC Name:
- 1,6-diisocyanatohexane
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Lippische Versuchstierzucht (Extertal, Germany)
- Age at study initiation: no data
- Weight at study initiation: 2.5 kg (mean weight)
- Housing: individual
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 7-14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16-18
- Humidity (%): 40
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 /12
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- amount applied: 0.5 ml (undiluted)
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 4, 24, 48, 72 hours and 8 days after application
- Number of animals:
- 6
- 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 covered with impermeable PVC foil
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with water
- Time after start of exposure: 4 hours
SCORING SYSTEM: according to DRAIZE
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 4 h
- Score:
- >= 3 - <= 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 4 h
- Score:
- >= 2 - <= 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 4 h
- Score:
- >= 3 - <= 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- other: 4 h
- Score:
- >= 3 - <= 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- other: 4 h
- Score:
- >= 3 - <= 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- other: 4 h
- Score:
- >= 3 - <= 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Reversibility:
- other: not reversible within 8 days
- Remarks on result:
- other: Application area imbibed with blood within 4 days; severe skin thickening. Epidermis subsequently changed like parchment (superficial dry necrosis).
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Reversibility:
- other: not reversible within 8 days
- Remarks on result:
- other: Application area imbibed with blood within 4 days; severe skin thickening. Epidermis subsequently changed like parchment (superficial dry necrosis).
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Reversibility:
- other: not reversible within 8 days
- Remarks on result:
- other: Application area imbibed with blood within 4 days; severe skin thickening. Epidermis subsequently changed like parchment (superficial dry necrosis).
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Reversibility:
- other: not reversible within 8 days
- Remarks on result:
- other: Application area imbibed with blood within 4 days; severe skin thickening. Epidermis subsequently changed like parchment (superficial dry necrosis).
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Reversibility:
- other: not reversible within 8 days
- Remarks on result:
- other: Application area imbibed with blood within 4 days; severe skin thickening. Epidermis subsequently changed like parchment (superficial dry necrosis).
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Reversibility:
- other: not reversible within 8 days
- Remarks on result:
- other: Application area imbibed with blood within 4 days; severe skin thickening. Epidermis subsequently changed like parchment (superficial dry necrosis).
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 4 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: 4 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: 4 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- other: 4 h
- Score:
- >= 2 - <= 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- other: 4 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- other: 4 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Reversibility:
- other: not reversible within 8 days
- Remarks on result:
- other: Application area imbibed with blood within 4 days; severe skin thickening. Epidermis subsequently changed like parchment (superficial dry necrosis).
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Reversibility:
- other: not reversible within 8 days
- Remarks on result:
- other: Application area imbibed with blood within 4 days; severe skin thickening. Epidermis subsequently changed like parchment (superficial dry necrosis).
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Reversibility:
- other: not reversible within 8 days
- Remarks on result:
- other: Application area imbibed with blood within 4 days; severe skin thickening. Epidermis subsequently changed like parchment (superficial dry necrosis).
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Reversibility:
- other: not reversible within 8 days
- Remarks on result:
- other: Application area imbibed with blood within 4 days; severe skin thickening. Epidermis subsequently changed like parchment (superficial dry necrosis).
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Reversibility:
- other: not reversible within 8 days
- Remarks on result:
- other: Application area imbibed with blood within 4 days; severe skin thickening. Epidermis subsequently changed like parchment (superficial dry necrosis).
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Reversibility:
- other: not reversible within 8 days
- Remarks on result:
- other: Application area imbibed with blood within 4 days; severe skin thickening. Epidermis subsequently changed like parchment (superficial dry necrosis).
Any other information on results incl. tables
The application area was swollen bloodily within 4 hours. 24 hours after patch removal all animals showed induration and necrosis of the application site up to observation day 8.
Applicant's summary and conclusion
- Interpretation of results:
- corrosive
- Remarks:
- Migrated information
- Executive summary:
In a dermal irritation/corrosion test 1,6-hexamethylene diisocyanate was corrosive to the skin of rabbits according to OECD TG 404.
Immediately after patch removal all treated animals showed severe edema and erythema (grade 4). The application area was swollen
bloodily within 4 hours. 24 hours after patch removal all animals showed induration and necrosis of the application site. Within the 8- day post-observation period no restitution with normal skin findings at the application site were observed.
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