Registration Dossier
Registration Dossier
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EC number: 257-098-5 | CAS number: 51274-00-1 This substance is identified in the Colour Index by Colour Index Constitution Number, C.I. 77492.
Endpoint summary
Administrative data
Description of key information
Valid studies for skin irritation/corrosion and eye irritation are available for FeOOH (nanomaterial).
FeOOH is not irritating to the skin nor to the eye.
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)
- Rationale for reliability incl. deficiencies:
- other: scientifically acceptable and sufficient documented
- Reason / purpose for cross-reference:
- reference to same study
- Principles of method if other than guideline:
- 2 New Zealand rabbits (3-4 kg) of both sex, treatment with 500 mg/animal for 24 hours, ear, after exposure removement of test substance with water and soap
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Duration of treatment / exposure:
- 24 hour(s)
- Observation period:
- 7 days
- Number of animals:
- 2
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 0, 24 h, 2, 3, 6, and 7 d
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information
- Executive summary:
- Two New Zealand rabbits (3-4 kg) of both sex, treatment with 500 mg/animal for 24 hours, ear, after exposure removement of test substance with water and soap.
Result: not irritating
- Endpoint:
- skin irritation: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available
- Reason / purpose for cross-reference:
- data waiving: supporting information
Referenceopen allclose all
Not irritating to the skin
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not 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)
- Rationale for reliability incl. deficiencies:
- other: scientifically acceptable and sufficient documented, low amount of test substance used
- Principles of method if other than guideline:
- 2 New Zealand rabbits (3-4 kg) of both sex, treatment with 50 mg/animal, conjunctival sac, observation period 7 days
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- New Zealand White
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 2
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 0, 24 h, 2, 5, 6, 7 d
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information
- Executive summary:
- Two New Zealand rabbits (3-4 kg) of both sex, treatment with 50 mg/animal, conjunctival sac, observation period 7 days.Result: not irritating
- Endpoint:
- eye irritation: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available
- Reason / purpose for cross-reference:
- data waiving: supporting information
Referenceopen allclose all
Not irritating to the eye
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
In the available studies FeOOH was not irritating to the eye and to the skin.
Justification for classification or non-classification
Due to the results of the available studies for FeOOH a classification is not justified
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