Registration Dossier
Registration Dossier
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EC number: 219-787-9 | CAS number: 2530-87-2
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1993/04/26-1993/05/19
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
Test material
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: white russian
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Dr. Karl Thomae GmbH, Chemisch-Pharmazeutische Fabrik, 88400 Biberach an der Riss 1
- Weight at study initiation: 2.4-2.6 kg
- Housing: Animals were individually housed in stainless steel metal cages.
- Diet: Ssniff K 4 Comprehensive diet for rabbits (ad libitum), Ssniff Special foods GmbH, 59494 Soest.
- Water: ad libitum
- Acclimation period: minimum of 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C ± 3°C
- Humidity (%): 30-70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12h/12h
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 cm3 undiluted
- Duration of treatment / exposure:
- 4 hour(s)
- Observation period:
- 1, 24, 48, and 72 hours and 6, 8, 10, 14 and 17 days
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: intact skin
- % coverage: 6 cm2
- Type of wrap if used: After the application of the test material, the area of exposure was covered with a plaster and bandaged over.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The test substance was removed by washing with warm water and patted dry.
- Time after start of exposure: 4 hours
SCORING SYSTEM: The test sites were examined for evidence of irritation one, 24, 48, and 72 hours and 6, 8, 10, 14 and 17 days after patch removal, and scored according to Draize, 1959.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 6 days
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 6 days
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 6 days
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 6 days
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 6 days
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 6 days
- Remarks on result:
- no 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: 72 hours
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 6 days
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 6 days
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 6 days
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 6 days
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 6 days
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- Erythema and edema were noted in all six animals at 24 and 48 hours after application. At 72 hours, three animals still exhibited erythema and three animals exhibited edema, and dryness of the skin was observed. Symptoms subsided by day 17.
Any other information on results incl. tables
Table 1: Irritant response data for each animal at each observation time up to removal of each animal from the test.
Score at time point / Reversibility |
Erythema |
Edema |
Max. score: 4 |
Max. score: 2 |
|
60 min |
2/2/2/2/2/2 |
2/2/2/1/1/2 |
24 h |
2/2/2/2/2/2 |
2/2/2/1/1/2 |
48 h |
2/2/2/2/2/2 |
1/2/2/1/1/2 |
72 h |
1/2/2/1/1/2 |
0/2/2/1/1/1 |
Reversibility*) |
c |
c |
Average time (unit) for reversion |
6 days |
6 days |
*) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible
Applicant's summary and conclusion
- Interpretation of results:
- Category 3 (mild irritant) based on GHS criteria
- Remarks:
- not classified according to Regulation (EC) No 1272/2008
- Conclusions:
- In the skin irritation study, conducted according to OECD Test Guideline 404 and in compliance with GLP, (3-chloropropyl)trimethoxysilane was not irritating to rabbit skin.
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