Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Endpoint summary
Administrative data
Description of key information
SKin irritation: Not irritating(OECD 404)
Eye irritatation: Not irritating(OECD 405)
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
- Reason / purpose for cross-reference:
- data waiving: supporting information
- 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
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- June 2002
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- New Zealand White
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Controls:
- no
- Amount / concentration applied:
- 0.5 mL of test material
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 3 days
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure:
6 cm*cm
REMOVAL OF TEST SUBSTANCE
- Washing (if done): using water
- Time after start of exposure: 4 hours
OBSERVATION TIME POINTS
1 h, 24 h , 48 h and 72 h
SCORING SYSTEM:
- Method of calculation: - Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Accoding to the results of Acute dermal irritation/Corrosion study, the test item was consiered as non- skin irritation.
- Executive summary:
In the acute dermal irritation/Corrosion study according to OECD TG 404, three male adult albino rabbits(New Zealand strain） were applied with 0.5 mL Reaction Product of 2-Hydroxybenzoic Acid, Styrene and Oxozinc for 4 hours by a semi-occlusive exposure.There was no erythema or oedema or any other changed induced, and the score of erythema and oedema were equal to 0.Therefore, the test item was consiered as non- skin irritation.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- 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
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2002
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- New Zealand White
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 1 h, 24 h, 48 h,72 h and 7 th day
- Number of animals or in vitro replicates:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 1-4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 1-4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal: 1-4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Other effects:
- not observed
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item was considered as non-irritation substance for eyes.
- Executive summary:
In the acute eye irritation/corrosion study according to OECD TG 405, four male adult albino rabbits(New Zealand strain） were applied with 0.1 mL test material for 24 hours .There was no redness or chemosis or discharge observed in cornea, iris or conjunctivae and the scores were equal to 0.Therefore, the test item was consiered as non-eye irritation.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation/corrosion
In the Acute dermal irritation/Corrosion study according to OECD TG 404, three male adultalbino rabbits(New Zealand strain） were applied with 0.5 mL test material for 4 hours by a semi-occlusive exposure.There was no erythema or oedema or any other changed induced, and the score of erythema and oedema were equal to 0.Therefore, the test item was consiered as non- skin irritation.
Eye irritation/corrosion
In the acute eye irritation/corrosion study according to OECD TG 405, four male adult albino rabbits(New Zealand strain） were applied with 0.1 mL test material for 24 hours .There was no redness or chemosis or discharge observed in cornea, iris or conjunctivae and the scores were equal to 0.Therefore, the test item was consiered as non-eye irritation.
Justification for classification or non-classification
Based on the available information in the dossier, the substance does not need to be classified for skin irritation/corrosion or serious eye damage/eye irritation when considering the criteria outlined in the CLP Regulation (Annex I of 1272/2008/EC).
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
