Registration Dossier
Registration Dossier
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EC number: 203-862-8 | CAS number: 111-36-4
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: 1 animal/exposure time tested; uncommon application site with regard to current guidelines
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1978
Materials and methods
- Principles of method if other than guideline:
- TEST ANIMALS: strain: New Zealand white sex: no data ADMINISTRATION/EXPOSURE: The undiluted compound (0.5 ml)
was applied to a gauze patch and applied in the rabbit ear, the patch was fixed. Exposure duration: 15 and 30 minutes
EXAMINATION: observations were made at the end of the exposure period, 24, 48, 120, 144, and 168 hours
(exposure time = 15 minutes) observations were made at the end of the exposure period, 24, 48, 72, 96, and 168 hours
(exposure time = 30 minutes) Both animals were killed after 7 days - GLP compliance:
- no
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Details on test material:
- IUCLID4 Test substance: other TS: n-butyl isocyanate, purity: techn. pure
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- not specified
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- undiluted
- Duration of treatment / exposure:
- 15 or 30 min
- Observation period:
- 7 days
- Number of animals:
- 1
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- exposure time: 15 min
- Time point:
- other: 24h, 48h, 144h, 7 d
- Score:
- 2.75
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: perforating corrosion
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- exposure time: 15 min
- Time point:
- other: 24h, 48h, 120h, 144h, 7 d
- Score:
- 1.8
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: perforating corrosion
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- exposure time: 30 min
- Time point:
- other: 24h, 48h, 72h, 96h, 7d
- Score:
- 2.4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: perforating corrosion
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- exposure time: 30 min
- Time point:
- other: 24h, 48h, 72h, 96h, 7 d
- Score:
- 1.6
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: perforating corrosion
- Irritant / corrosive response data:
- from day 1 (30 min exposure) or from day 2 (15 min exposure) development of a perforating corrosion of the skin was seen
Any other information on results incl. tables
SCORE:
Exposure time: 15 minutes
Erythema (observation time): 2, 3, 3, 3 (24h, 48h, 144h, 7d)
Edema (observation time): 0, 2, 2, 2, 2 (24h, 48h, 120h,
144h, 7d)
Corrosion (observation time): 0, 1, 3, 3, 3 (24h, 48h,
120h, 144h, 7d)
Exposure time: 30 minutes
Erythema (observation time): 3, 3, 2, 2, 2 (24h, 48h, 72h,
96h, 7d)
Edema (observation time): 2, 3, 1, 1, 1 (24h, 48h, 72h, 96h,
7d)
Corrosion (observation time): 2, 2, 2, 3, 3 (24h, 48h, 72h,
96h, 7d)
Applicant's summary and conclusion
- Interpretation of results:
- highly corrosive
- Remarks:
- Migrated information
- Executive summary:
ADMINISTRATION/EXPOSURE: The undiluted compound (0.5 ml)
was applied to a gauze patch and applied in the rabbit ear, the patch was fixed. Exposure duration: 15 and 30 minutes
EXAMINATION: observations were made at the end of the exposure period, 24, 48, 120, 144, and 168 hours
(exposure time = 15 minutes) observations were made at the end of the exposure period, 24, 48, 72, 96, and 168 hours
(exposure time = 30 minutes) Both animals were killed after 7 days
RESULT: butyl isocyanate is highly corrosive
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