Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 210-204-3 | CAS number: 609-99-4
Eye irritation
Administrative data
- 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:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 990
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- not specified
- GLP compliance:
- not specified
Test material
- Reference substance name:
- 3,5-dinitrosalicylic acid
- EC Number:
- 210-204-3
- EC Name:
- 3,5-dinitrosalicylic acid
- Cas Number:
- 609-99-4
- Molecular formula:
- C7H4N2O7
- IUPAC Name:
- 3,5-dinitrosalicylic acid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: chemiclas used in this study were purchased from Wako Pure Chemical Industry (Osaka, Japan), Sigma Chem. Co. (St. Louis, USA), Aldrich Chemical Company (Wisconsin, USA), Dojindo Laboratories (Kumamoto, Japan), Tokyo Kasei Kogyo Co. (Tokyo, Japan)
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: Female Japanese white rabbits
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Takeo breeder, Shizuoka, Japan
- Weight at study initiation: 2.0-2.2 kg
- Housing: metal cages (39 X40 X44 cm
- Diet (e.g. ad libitum): RC4 diet, Oriental Yeast Co., Tokyo, Japan, ad libitum
- Water (e.g. ad libitum): water ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 25±1°C
- Humidity (%): 55±5%
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg
VEHICLE
- Amount(s) applied (volume or weight with unit): none - Duration of treatment / exposure:
- single application
ocular reaction was recorded 1, 4, 24, 48, 72, 96hr, 7, 14 and 21 days after the treatment - Observation period (in vivo):
- ocular reaction was recorded 1, 4, 24, 48, 72, 96hr, 7, 14 and 21 days after the treatment
- Number of animals or in vitro replicates:
- three
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): not specified
SCORING SYSTEM: Draize score (Draize et al., 1944
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: # 1-3 each
- Reversibility:
- fully reversible within: 24 h
- Remarks on result:
- other: Non-or mild irritant
- Irritation parameter:
- iris score
- Basis:
- animal: # 1-3 each
- Reversibility:
- fully reversible within: 24 h
- Remarks on result:
- other: Non-or mild irritant
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: # 1-3 each
- Reversibility:
- fully reversible within: 24 h
- Remarks on result:
- other: Non-or mild irritant
- Irritation parameter:
- chemosis score
- Basis:
- animal: # 1-3 each
- Reversibility:
- fully reversible within: 24 h
- Remarks on result:
- other: Non-or mild irritant
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- The test item has not to be classified for eye irritation according to Regulation (EC) No 1272/2008.
- Conclusions:
- The test item was found to be a non-or mild irritant which shows at most minimal irritation recovering within 24 hr.
Therefore, the test item has not to be classified for eye irritation according to Regulation (EC) No 1272/2008. - Executive summary:
Three healthy female Japanese white rabbits were used for testing of eye irritation according to OECD TG 405. The test item (100 mg) was placed into the conjunctival sac of the left eye. The right eye was served as a blank. The eyes were examined and the grade of ocular reaction was recorded 1, 4, 24, 48, 72, 96 hr, 7, 14 and 21 days after the treatment. Corneal opacity, erythema, chemosis, and iritis were classified according to the Draize score. The eye irritation score and recovery time of corneal and conjunctival damages were used as the grade of eye irritation potential.
The test item was found to be a non-or mild irritant which shows at most minimal irritation recovering within 24 hr.
Therefore, the test item has not to be classified for eye irritation according to Regulation (EC) No 1272/2008.
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.
