Registration Dossier
Registration Dossier
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EC number: 259-224-4 | CAS number: 54553-90-1
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- male/female (each 3)
- Type of coverage:
- occlusive
- Vehicle:
- other: paraffin oil
- Controls:
- other: animals were their own control
- Amount / concentration applied:
- 500 mg
- Duration of treatment / exposure:
- 4h exposure
- Observation period:
- 8 days
- Number of animals:
- 6 (3 male and 3 female)
- Details on study design:
- TEST ANIMALS:
- Strain: New Zealand white
- Sex: male and female
- Source: Dr. Karl Thomae GmbH, Biberach (Germany)
- Weight at study initiation: 3.7 - 4.9 kg
- Number of animals: 3 males, 3 females
ADMINISTRATION/EXPOSURE
- Preparation of test substance: 0.5 g wetted with paraffin oil
- Area of exposure: 6 cm2
- Occlusion: mull patch, polyethylene film, elastic dressing
- Removal of test substance: washing with warm water
- Post exposure period: 8 days
EXAMINATIONS
- Scoring system: OECD; evaluation: VCI notes on safety data sheet and
Appendix VI of 79/831/EEC
- Examination time points: 1, 24, 48, 72 hours, 6 and 8 days after patch
removal; evaluation based on readings 1-4 - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 4h
- Score:
- 1.28
- Max. score:
- 8
- Reversibility:
- fully reversible within: 8d
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 4h
- Score:
- 0.11
- Max. score:
- 8
- Reversibility:
- fully reversible within: 8d
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 4h
- Score:
- 1.29
- Max. score:
- 8
- Reversibility:
- fully reversible within: 8d
- Irritant / corrosive response data:
- AVERAGE SCORE
- Erythema: 1.28
- Edema: 0.11
- irritation index: 1.29/8
REVERSIBILITY: complete within 8 days
OTHER EFFECTS: eschar formation in 3 animals (day 6) - Interpretation of results:
- slightly irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Classification : not irritating
Reference
See also attached IUCLID4 dossier.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- 0.1 g of 100% substance
- Duration of treatment / exposure:
- 72h not rinsed
- Observation period (in vivo):
- 6d
- Number of animals or in vitro replicates:
- 6 (3 male, 3 female)
- Details on study design:
- - Strain: New Zealand white
- Sex: male and female
- Source: Dr. Karl Thomae GmbH, Biberach (Germany)
- Weight at study initiation: 4.3 - 5.3 kg
- Number of animals: 3 males, 3 females
- Controls: untreated eye
ADMINISTRATION/EXPOSURE
- Amount of substance instilled: 0.1 g
- Postexposure observation period: 6 days
EXAMINATIONS
- Ophtalmoscopic examination: 1, 24, 48, 72 hours, and 6 days after
treatment
- Scoring system: Draize (1959); evaluation: VCI notes on safety data
sheet and Appendix VI of 79/831/EEC
- Tool used to assess score: sodium fluorescein / ophthalmic lamp / visual
inspections - Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 72h
- Score:
- 3.75
- Max. score:
- 110
- Reversibility:
- fully reversible within: 6d
- Irritant / corrosive response data:
- AVERAGE SCORE
- Cornea: 0
- Iris: 0
- Conjunctivae (Redness): 0.94
- Conjunctivae (Chemosis): 0.11
- Overall irritation score: 3.75/110
REVERSIBILITY: complete in 6 days
OTHER EFFECTS: distinct redness in nictitating membranes of all animals
at 24 hours only - Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
At the obserevd effect levels for skin and eye irritation there is no requirement for classification
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