Registration Dossier
Registration Dossier
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EC number: 411-280-2 | CAS number: 74091-64-8 MR-8A; MR-N2; NBDI
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- March 6, 1992 - December 23, 1992
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
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:
- 2,5-bis-isocyanatomethyl-bicyclo[2.2.1]heptane
- EC Number:
- 411-280-2
- EC Name:
- 2,5-bis-isocyanatomethyl-bicyclo[2.2.1]heptane
- Cas Number:
- 74091-64-8
- Molecular formula:
- C11H14N2O2
- IUPAC Name:
- (1R,2R,4R,5R)-2,5-bis(isocyanatomethyl)bicyclo[2.2.1]heptane; (1R,2S,4R,5S)-2,5-bis(isocyanatomethyl)bicyclo[2.2.1]heptane; (1S,2R,4S,5R)-2,5-bis(isocyanatomethyl)bicyclo[2.2.1]heptane; (1S,2S,4S,5S)-2,5-bis(isocyanatomethyl)bicyclo[2.2.1]heptane; bis((1r,2R,4s,6S)-2,6-bis(isocyanatomethyl)bicyclo[2.2.1]heptane); bis((1s,2R,4r,6S)-2,6-bis(isocyanatomethyl)bicyclo[2.2.1]heptane)
- Details on test material:
- - Name of test material (as cited in study report): NBDI
- Physical state: liquid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Thomae, Biberach (6 males)
- Age at study initiation: no data
- Weight at study initiation: 2.25 kg +/- 0.172
- Housing: Building F-3, Rabbits per steel wire cage: 1
- Diet (e.g. ad libitum):ad libitum
- Water (e.g. ad libitum):ad libitum
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +/- degrees Celsius
- Humidity (%): 45-65%
- Air changes (per hr): 12-15 times/hour
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: July 28, 1992 To: August 19, 1992
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
Amount(s) applied (volume or weight with unit): 0.5 mL
VEHICLE: Not applicable - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 14 days
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: 6 cm2 (2x3 cm gauze patch)
- Type of wrap if used: wrapping of gauze which was secured and semioccluded by a wrapping of fixomull.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes
- Time after start of exposure: After a 4-hour exposure period wrappings were removed and the substance was washed away with water
SCORING SYSTEM: According to the method of Draize
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 2.33
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.66
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 2.66
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Remarks on result:
- positive indication of irritation
- Irritant / corrosive response data:
- Reversibility of any observed effect: Changes not fully reversible within 14 days in all animals.
- Other effects:
- The skin reactions increased up to 24 hours. After about 10 days, the upper layers of the skin fell off and the skin underneath was visible. It showed a beat red, shiny surface, which was about to heal.
Any other information on results incl. tables
Macroscopic findings during necropsy:
Animal No. |
Pathol. No. |
Necropsy day |
Macroscopic finding |
1 |
150/92 |
14 |
Treated skin severely red (beat red) |
2 |
151/92 |
14 |
Treated skin red and scabby |
3 |
152/92 |
14 |
Treated skin red and scabby |
4 |
153/92 |
14 |
Treated skin red and scabby (petechiae in the underneath subcutaneous tissue) |
5 |
154/92 |
14 |
Treated skin red and scabby (petechiae in the underneath subcutaneous tissue) |
6 |
155/92 |
14 |
Treated skin red, scabby and ruptured |
Applicant's summary and conclusion
- Interpretation of results:
- Category 1C (corrosive)
- Conclusions:
- Based on the results of an in vivo skin irritation test performed according to OECD guideline 404, NBDI is classified Corrosive to skin (Category 1C).
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