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EC number: 264-120-7 | CAS number: 63393-96-4
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2 Oct - 24 Oct 1989
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP Guideline study (OECD) with some divations, since the test substance was not characterized in detail.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- directive 84/449/EWG, 19. Sept, 1984
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Quaternary ammonium compounds, tri-C8-10-alkylmethyl, chlorides
- EC Number:
- 264-120-7
- EC Name:
- Quaternary ammonium compounds, tri-C8-10-alkylmethyl, chlorides
- Cas Number:
- 63393-96-4
- Molecular formula:
- Unspecified
- IUPAC Name:
- Quaternary ammonium compounds, tri-C8-10-alkylmethyl, chlorides
- Details on test material:
- - Physical state: yellow brownish, oily liquid
- Analytical purity: not specified
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: Kleinrusse, Chbb: HM
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Fa. Thomae, Biberach, Germany
- Age at study initiation: 10-11 months
- Weight at study initiation: mean: 2550 g
- Housing: single in rabbit batteries
- Diet: Altromin Haltungsdiät 2023, Fa. Altromin, Lage, Germany, ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least a week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-25
- Humidity (%): 45-70
- 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 sites of the same animal served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 21 days
reading time points: 1, 24, 48, 72 hours, 7, 14 and 21 days - Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 6 cm² on the back
- Type of wrap if used: air and water vapor permeable paving fixed with a hypoallergen bandage
SCORING SYSTEM: Draize Scoring System
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: 21 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 3.67
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21 days
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21 days
- Remarks on result:
- other: scabs were seen at application site starting at 24 hours
- Irritant / corrosive response data:
- Severe redness (score 3-4) and edema (score 3-4) were observed up to the 72 hour reading time point. Effects were not completely reversible until Day 21 and on Day 21 at the end of the observation period one animal still showed erythema (score 3) and the other 2 animals slight erythema (score 1). No edema was seen anymore but all animals showed scar tissue.
- Other effects:
- Scabs were also seen already 24 hours after removal of the test substance. Additionally brownish coloring of the application site was observed at the 72 h reading time point. At Day 21 all animals showed scabs and scar tissue.
Any other information on results incl. tables
Table 1. Results of skin irritation study.
Observation time |
Rabbit no. |
|||||
1 |
2 |
3 |
||||
Erythema |
Edema |
Erythema |
Edema |
Erythema |
Edema |
|
1 h |
4 |
3 |
3 |
3 |
3 |
3 |
24 h |
4 |
3S |
3 |
3S |
4 |
3S |
48 h |
4 |
3S |
4 |
3S |
4 |
3S |
72 h |
4b |
3S |
4b |
3S |
4b |
3S |
21 days |
3 |
0S |
1 |
0S |
1 |
0S |
Mean value 24 + 48 + 72 h |
4 |
3 |
3.67 |
3 |
4 |
3 |
Mean value 24 + 48 + 72 h all animals |
3.89 |
3 |
|
|
|
|
S = scabs, b = brownish staining
Applicant's summary and conclusion
- Interpretation of results:
- corrosive
- Conclusions:
- DSD: C, R34
CLP: Category 1C, H314
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