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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 298-265-2 | CAS number: 93783-70-1
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- other: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- From November 15 to 22, 1988
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Remarks:
- Source study has reliability 1. Details on the read across are available in section 13.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- not specified
- GLP compliance:
- yes
Test material
- Reference substance name:
- Similar Substance 01
- IUPAC Name:
- Similar Substance 01
- Test material form:
- liquid
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Interfauna UK Ltd
- Weight at study initiation: 3.2 kg
- Housing: one rabbit per cage (Drahtkäfige Typ III - hoch)
- Pellet: Holzgranulat Typ S 8/15 (Firma Sniff, Soest)
- Diet: ca. 100 - 120 g per animal per day of Sniff K 4 (Sniff Spezialdiäten GmbH, Soest/Westfallen)
- Water: ad libitum
- Acclimation period: 1 day
ENVIRONMENTAL CONDITIONS
- Temperature: 20 ± 3 °C
- Humidity: ca. 50%
- Air changes: ca. 10 times per hours
- Photoperiod (hrs dark / hrs light): 12 hours/12 hours (ca. 27 Watt/m2)
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 µl
- pH: 0.5 - Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 1 female rabbit
- Details on study design:
- APPLICATION:
After the application of the test substance, the lids were held together for about 1 second
REMOVAL OF TEST SUBSTANCE
- Washing: with saline solution
- Time after start of exposure: 24 hours
SCORING SYSTEM: Draize grade
TOOL USED TO ASSESS SCORE: in order to analyse cornea and iris, optical device and fluorecina (1 %)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Remarks:
- opacity
- Basis:
- animal: T52
- Time point:
- other: mean score (24, 48, 72 h)
- Score:
- ca. 2.7
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- cornea opacity score
- Remarks:
- area
- Basis:
- animal: T52
- Time point:
- other: mean score (24, 48, 72 h)
- Score:
- ca. 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- iris score
- Basis:
- animal: T52
- Time point:
- other: mean score (24, 48, 72 h)
- Score:
- ca. 2
- Max. score:
- 2
- Reversibility:
- not reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: T52
- Time point:
- other: mean score (24, 48, 72 h)
- Score:
- ca. 3
- Max. score:
- 4
- Reversibility:
- not reversible
Any other information on results incl. tables
| animal no. | weight | sex | target | symptome | 1 h | 24 h | 48 h | 72 h | 7 d | 14 d |
| T52 | 3.2 kg | F | cornea | T | X | 2 | 3 | 3 | - | - |
| F | X | 4 | 4 | 4 | - | - | ||||
| fluorescein | I | - | 2 | 3 | 3 | - | - | |||
| F | - | 4 | 4 | 4 | - | - | ||||
| iris | X | 2 | 2 | 2 | - | - | ||||
| conjunctivae | R | X | 3 | 3 | 3 | - | - | |||
| S | 4 | 3 | 3 | 3 | - | - | ||||
humor aquosus |
X | nb | nb | nb | - | - | ||||
| lacrimation | 2 | 2 | 2 | 2 | - | - |
T = opacity, F = area, I = intensity, R = redness, S = swelling, X = impossible to judge, nb = impossible to judge for opacity, - = not applicable
Applicant's summary and conclusion
- Interpretation of results:
- other: cat. 1 causes serious eye damage, according to the CLP Regulation (EC 1272/2008)
- Conclusions:
- The substance causes serious eye damage.
- Executive summary:
Method
The substance was tested for eye damage according to OECD guideline 405, using one albino rabbit, as recommended in the guideline.
Results
The observed effects were not reversible by 72 hours. Test substance caused seriuos eye damage.
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.
