Registration Dossier
Registration Dossier
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EC number: 932-164-2 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 2 August 1991 to 26 November 1991
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Details on test material:
- - Physical state: clear yellow liquid
- Stability under test conditions: stable
- Storage condition of test material: between 20-30ºC in the dark
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Broekman Institute, Someren, The Netherlands
- Age at study initiation: Approx. 19 weeks
- Weight at study initiation: 3260-3362 grams
- Diet (e.g. ad libitum): 100 grams per day
- Water (e.g. ad libitum): free access
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21ºC
- Humidity (%): 55
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 1, 24, 48 and 72 hours and 7, 14 and 21 days
- Number of animals:
- 3 animals
- Details on study design:
- TEST SITE
- Area of exposure: 10 cm x 10 cm
- Type of wrap if used: one flack, surgical gauze patch 2x3 cm
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7d: 2, 14d:0, 21d:1
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2.6
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7d: 2, 14d:0, 21d:0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7d: 2, 14d:1, 21d:1
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7d: 0, 14d:1, 21d:2
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7d: 2, 14d:1, 21d:1
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2.3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7d: 1, 14d:1, 21d:1
- Remarks on result:
- positive indication of irritation
Any other information on results incl. tables
| Observation time | Rabbit no. Erythema | 679 Oedema | Rabbit no. Erythema | 680 Oedema | Rabbit no. Erythema | 681 Oedema |
| 24 hours | 2 | 3 | 4 | 2 | 2 | 3 |
| 48 hours | 2 | 3 | 4 | 2 | 3 | 2 |
| 72 hours | 2 | 2 | 4 | 2 | 4 | 2 |
| Mean value | 2 | 2,7 | 4 | 2 | 3 | 2,3 |
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Conclusions:
- The substance resulted in a primary irritation index 5.3 (severaly irritating) when applied to the intact rabbit skin.
- Executive summary:
This study was entitled "Primary skin irritation/corrosion study with the substance in the rabbit (4-hour semi-occlusive application)".
The purpose of this study was to assess the possible irritation or corrosion potencial of the substance when a single dose was placed on the skin of rabbits. Under the conditions of this study, the substance resulted in well defined or severe erythema and slight or moderate oedema in the three animals. The skin irritation had not resolved within the study period and no corrosive effect occurred on the skin in all three animals.
The substance resulted in a primary irritation index of 5.3 (severely irritating) when applied to intact rabbit skin.
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