Registration Dossier
Registration Dossier
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EC number: 278-859-8 | CAS number: 78181-99-4
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- preparation containing CAS 78181-99-4
- IUPAC Name:
- preparation containing CAS 78181-99-4
- Details on test material:
- Please refer to the confidential details on test material
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Gaukler, Offenbach/Main
- Weight at study initiation: mean males: 2.54 kg, female 2.57 kg
- Housing: single housing in stainless steel cages with wire mesh walk floors, floor area 40 cm x 51 cm
- Diet: about 130 g/day, Kliba 341, 4 mm; Klingenthalmuehle AG, Kaiseraugst, Switzerland
- Water: about 250 mL tap water/day
- Acclimation period: at least 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12 / 12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated skin sites of the same animal
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 mL
- Concentration: undiluted - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 3 rabbits (2 males, 1 female)
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm on upper third of the back or flanks
- Type of wrap if used: test patches were secured in position with a porous dressing (four layers of absorbent gauze + porous bandage)
REMOVAL OF TEST SUBSTANCE
- Washing: at the end of the exposure period with Lutrol and Lutrol/water (1:1)
- Time after start of exposure: 4 hours
SCORING SYSTEM: according to OECD guideline
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 24, 48, 72h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 24, 48, 72h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 24, 48, 72h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 24, 48, 72h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: 24, 48, 72h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: 24, 48, 72h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritant / corrosive response data:
- Treatment with the test substance resulted in erythema (score 1) in 1/3 rabbits at the 24-hour reading, which fully reversed within 48 hours. No erythema was observed in the 2 remaining rabbits. There were no edema in 3/3 rabbits.
For details, see table below.
Any other information on results incl. tables
Irritation scores:
Timepoint |
Animal No. |
Intact skin |
Symptoms |
|
Erythema |
Edema |
|
||
4 h |
1 |
0* |
0 |
Irritation index could not be read because of staining due to the color of the test substance |
2 |
0 |
0 |
|
|
3 |
0* |
0 |
Irritation index could not be read because of staining due to the color of the test substance |
|
24 h |
1 |
1 |
0 |
|
2 |
0 |
0 |
|
|
3 |
0 |
0 |
|
|
48 h |
1 |
0 |
0 |
|
2 |
0 |
0 |
|
|
3 |
0 |
0 |
|
|
72 h |
1 |
0 |
0 |
|
2 |
0 |
0 |
|
|
3 |
0 |
0 |
|
|
|
Timepoints |
|||
Mean |
1 |
0.3 |
0.0 |
24, 48, 72h |
Mean |
2 |
0.0 |
0.0 |
24, 48, 72h |
Mean |
3 |
0.0 |
0.0 |
24, 48, 72h |
Mean |
1 - 3 |
0.1 |
0.0 |
24, 48, 72h |
* if in 1 – 2 animals assessments referring to erythema cannot be made at a particular reading, the mean rounded to the nearest whole number of the values that can be read is inserted instead.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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