Registration Dossier
Registration Dossier
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EC number: 234-576-1 | CAS number: 12012-35-0
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 2-9 August 1988
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Read-across to chromium(III) oxide. The release of chromium from chromium carbide is very similar to the release from chromium metal and chromium(III) oxide and therefore the results obtained with these substances can readily be used in the assessment of trichromium dicarbide. OECD guideline study. Reliability score 1 although read-across due to the very similar release of chromium from trichromium dicarbide and chromium(III) oxide.
Cross-reference
- Reason / purpose for cross-reference:
- reference to same 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:
- chromium oxide
- IUPAC Name:
- chromium oxide
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Strain New Zealand White rabbits strain HC:NZW, obtained from Interfauna UK Ltd
- Age at study initiation: adults (no details in report)
- Weight at study initiation: 2.8-3.4 kg
- Housing: One animal per cage, bedding with soft wood granules
- Diet (e.g. ad libitum): Stadard diet "ssniff K 4" from Ssniff Spezialdiäten GmbH, Soest/Westfahlen, Germany. Ca 100-120 g/animal/day, feeding every morning.
- Water (e.g. ad libitum): yes
- Acclimation period: minumum 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±2 degrees Celsius
- Humidity (%): ca 50%
- Air changes (per hr): ca 10 times/h
- Photoperiod (hrs dark / hrs light): 12 hrs dark / 12 hrs light
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- other: untreated contralateral skin area served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg, mixed with a small amount of water to paste-like - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 7 days
- Number of animals:
- 3
- Details on study design:
TEST SITE
- Area of exposure: ca 6 cm2 shaved area of the loin
- % coverage: no data
- Type of wrap if used: Hansamed-Wundpflaster 'Hypoallergen' (Beiersdorf No 2342)
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with water
- Time after start of exposure: 4 h
SCORING SYSTEM: based on the DRAIZE-grade; observation times 24, 48 and 72 h and 7 days after application. Erythema scoring 0-4, oedema scoring 0-4.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal:
- Remarks:
- 3
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- other: DRAIZE-grading
- Irritation parameter:
- edema score
- Basis:
- animal:
- Remarks:
- 3
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- other: DRAIZE-grading
- Irritation parameter:
- erythema score
- Basis:
- animal:
- Remarks:
- 3
- Time point:
- 7 d
- Score:
- 0
- Remarks on result:
- other: DRAIZE-grading
- Irritation parameter:
- edema score
- Basis:
- animal:
- Remarks:
- 3
- Time point:
- 7 d
- Score:
- 0
- Remarks on result:
- other:
- Remarks:
- DRAIZE-grading
- Irritant / corrosive response data:
- No signs of irritation were observed during the 7 day follow-up period.
- Other effects:
- No other symptoms were observed.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: OECD GHS
- Conclusions:
- The test substance did not cause irritation. Chromium(III) oxide should thus be classified as not-irritant.
- Executive summary:
Skin irritation of chromium oxide was tested in three rabbits according to the GLP and the OECD test guideline 404. 500 mg of chromium oxide was applied under an adhesive patch to the shaved loin of the animals for 4 hours. The skin was carefully washed after the removal of the patch, and symptoms were observed during a follow-up period of 7 days. No signs of irritation were observed, indicating that chromium (III) oxide is non-irritant.
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