Registration Dossier
Registration Dossier
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: 500-199-9 | CAS number: 68183-39-1
Toxicological information
Eye irritation
Currently viewing:
Administrative data
- Endpoint:
- eye irritation: in vivo
- Remarks:
- other: Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics (1959) by the U.S.
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1978
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- The study has been performed before GLP guidelines and OECD guidelines were in place for industrial chemicals. The study has been performed in a lab experienced to work under GLP for pharmaceuticals. The test method is similar to the later used OECD guideline method.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1978
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics (1959) by the U.S.
- Deviations:
- no
- GLP compliance:
- no
Test material
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: particulates
- Details on test material:
- - Substance type: organic
- Physical state: solid
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- Himalayan
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 1.5 - 2.0 kg
- Housing: individual metal cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: minumum 4 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/-1
- Humidity (%): 55 +/-5
- Photoperiod (hrs dark / hrs light): 14 / 10
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g - Duration of treatment / exposure:
- In half of the animals the treatment lasted for 30 seconds (time of flushing with water)
In half of the animals the treatment was not stopped. - Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): in half of the animals the eye was flushed with 10 ml lukewarm water
- Time after start of exposure: 30 seconds
SCORING SYSTEM: Draize scoring system
TOOL USED TO ASSESS SCORE: hand-slit lamp
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24 hours, unrinsed
- Score:
- ca. 13
- Max. score:
- 20
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: maximum possible score is 80
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 48 hours, unrinsed
- Score:
- ca. 13
- Max. score:
- 20
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 72 hours, unrinsed
- Score:
- ca. 10
- Max. score:
- 20
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 96 hours, unrinsed
- Score:
- ca. 7
- Max. score:
- 15
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 7 days, unrinsed
- Score:
- ca. 3.3
- Max. score:
- 5
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24 hours - 7 days, unrinsed
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no effect
- Remarks on result:
- other: maximum possible score is 10
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24 hours, unrinsed
- Score:
- ca. 15
- Max. score:
- 16
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: maximum possible score is 20
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 48 hours, unrinsed
- Score:
- ca. 14
- Max. score:
- 16
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 72 hours, unrinsed
- Score:
- ca. 11
- Max. score:
- 14
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 96 hours, unrinsed
- Score:
- ca. 7
- Max. score:
- 12
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 7 days, unrinsed
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible within: 7 days
Applicant's summary and conclusion
- Interpretation of results:
- Category 2B (mildly irritating to eyes)
- Remarks:
- Migrated information Criteria used for interpretation of results: expert judgment
- Conclusions:
- The effects are mild, however cornea effects are not fully reversible within 7 days.
- Executive summary:
The effects are mild, however cornea effects are not fully reversible within 7 days.
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.
