Registration Dossier
Registration Dossier
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EC number: 202-525-2 | CAS number: 96-69-5
Toxicological information
Skin irritation / corrosion
Currently viewing:
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- February 28 - April 4, 1986
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Although the study was quite old and not performed under GLP conditions, the described study method was comparable to OECD Guideline 404.
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1986
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- not under GLP conditions, study dates 1986
- GLP compliance:
- not specified
Test material
- Details on test material:
- - Name of test material (as cited in study report): Slz WX-R
- Analytical purity: 99.93%
- Lot/batch No.: 8623
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Japan Lab Animals Co., Ltd.
- Age at study initiation: not mentioned.
- Weight at study initiation: 2.05-2.47 kg
- Housing: individual metal mesh-bottomed suspenses cages.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 14 - 42 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 - 27
- Humidity (%): 45 - 75
- Air changes (per hr): not mentioned
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- physiological saline
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 4.5, 24, 48, 72 hours and 1 week
- Number of animals:
- 3 rabbits
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- % coverage:
- Type of wrap if used: lint clot with PBS plus surgical tape
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, gauze with water
- Time after start of exposure: 4 hours
SCORING SYSTEM: Draize criteria
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 4.5 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 1 week
- Remarks on result:
- other: (non) wounded test site
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 1 week
- Remarks on result:
- other: (non) wounded test site
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 48 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 1 week
- Remarks on result:
- other: (non) wounded test site
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 72 h
- Score:
- 1.6
- Max. score:
- 2
- Reversibility:
- fully reversible within: 1 week
- Remarks on result:
- other: non wounded test site
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 72 h
- Score:
- 1.3
- Max. score:
- 2
- Reversibility:
- fully reversible within: 1 week
- Remarks on result:
- other: wounded test site
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 1 week
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: (non) wounded test site
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 4.5 h
- Score:
- 0.6
- Max. score:
- 1
- Reversibility:
- fully reversible within: 1 week
- Remarks on result:
- other: non wounded test site
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 4.5 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 1 week
- Remarks on result:
- other: wounded test site
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24 h
- Score:
- 1.6
- Max. score:
- 2
- Reversibility:
- fully reversible within: 1 week
- Remarks on result:
- other: (non) wounded test site
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 48
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 1 week
- Remarks on result:
- other: (non) wounded test site
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 72 h
- Score:
- 0.6
- Max. score:
- 1
- Reversibility:
- fully reversible within: 1 week
- Remarks on result:
- other: non wounded test site
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 72 h
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible within: 1 week
- Remarks on result:
- other: wounded test site
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 1 week
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: (non) wounded test site
- Irritant / corrosive response data:
- 4.5 hours after the application of Slz WX-R, all of the cases (3 cases) showed erythema and edema in both the wounded site and the non-wounded site with a strength level of 1, at approximately the same extent for both findings. By 24 hours after application, the erythema had increased in intensity to a strength level of 2 in all of the cases, while the edema ranged in strength from 1 to 2. However, these local reactions gradually lessened, and by 1 week after application, all of the local reactions had disappeared.
The primary irritation rate that was calculated based on the above-noted results was 2.83, indicating that Slz WX-R will show moderate irritation of rabbit skin. - Other effects:
- none
Any other information on results incl. tables
none
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- A study in 3 rabbits revealed that Slz WX-R 6 was moderately irritanting after 4-hour exposure. The study was not performed according to the general guidelines for acute dermal irritation/corrosion under GLP conditions, but was well performed and documented and as such considered reliable with minor restrictions.
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