Registration Dossier
Registration Dossier
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EC number: 433-100-1 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1999-01-18 to 1999-01-28
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- adopted 17 July, 1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- Directive 92/69
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- Version / remarks:
- June 1996
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland GmbH, D-88353 Kißlegg
- Weight at study initiation: 2.0 to 2.1 kg
- Housing: Individually housed in ABS - plastic rabbit cages
- Diet: ad libitum, Altromin 2123 maintenance diet for rabbits, rich in crude fibre, totally pathogene free-TPF
- Water: ad libitum, tap drinking water
- Acclimation period: 1 week
ENVIRONMENTAL CONDITIONS
- Temperature: 18 ±3 °C
- Humidity: 55 ± 10%
- Air changes: at least 10 x / hour
- Photoperiod: Artificial light, lighting regime 12 : 12 hours, light 6.30 - 18.30
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- other: Carboxymethylcellulose
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.5 g - Duration of treatment / exposure:
- 4 h
- Observation period:
- 1, 24, 48, 72 h
- Number of animals:
- 3 female animals
- Details on study design:
- TEST SITE
- Area of exposure: (approx. 6 cm2) of skin
- Type of wrap if used: gauze patch, which was held in place with non-irritating tape
REMOVAL OF TEST SUBSTANCE
- Washing: yes
- Time after start of exposure: 4 hours
SCORING SYSTEM: Scoring system according to Draize
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritant / corrosive response data:
- No skin reactions (erythema, oedema) were recorded throughout the observation period of 72 hours as compared to untreated control sites.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item showed no irritant effects on the intact skin after a contact time of 4 hours.
- Executive summary:
The test material was assessed for skin irritation properties according to EU Method B.4/OECD Guideline 404. The test material was applied to the intact skin of New Zealand White rabbits in a single, 4 -hour, semi-occluded application of the test material to the intact skin of three female animals. The test material produced edema scores of 0.0 after 24, 48 and 72 h and erythema scores of 0.0 after 24, 48 and 72 h in all animals and was classified as non-irritatant to the rabbit skin. No corrosive effects were noted.
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