Registration Dossier
Registration Dossier
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EC number: 402-950-5 | CAS number: 87826-41-3 CLEARLITE NU 005; DISORBENE M; GENISET MD; GLC NU 005; MILLAD 3940; NU 005
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin irritation / corrosion
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: A study summary was made available by ECHA under Article 25, Para 3, of EC Regulation 1907/2006.
- Qualifier:
- according to guideline
- Guideline:
- other: EC Annex V
- GLP compliance:
- yes
- Species:
- rabbit
- Amount / concentration applied:
- ca. 30 mg (0.1 ml powder)
- Duration of treatment / exposure:
- 4 hours
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 3
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: 24,48 and 72 hours
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: 24,48 and 72 hours
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: 24,48 and 72 hours
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: 24,48 and 72 hours
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: 24,48 and 72 hours
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- other: 24,48 and 72 hours
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: 24,48 and 72 hours
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- other: 24,48 and 72 hours
- Score:
- 0.3
- Reversibility:
- not specified
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- other: 24,48 and 72 hours
- Score:
- 0.3
- Reversibility:
- not specified
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: 24,48 and 72 hours
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- other: 24,48 and 72 hours
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- other: 24,48 and 72 hours
- Score:
- 0
- Other effects:
- Transient slight or moderate conjunctival redness was observed amongst the three animals at the 1 hour post dose observation.
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The substance is not irritant to rabbit eyes.
Reference
Additional information
Three reliable, GLP compliant, acute in vivo skin irritation studies are available, conducted to recognised test guidelines. There was no significant skin irritation response observed in any of the studies.
Three reliable, GLP compliant, acute in vivo eye irritation studies are available, conducted to recognised test guidelines. In the key study (Toxicol Laboratories Ltd.,1988) conjuctival redness and corneal opacity were observed amonst three of three rabbits and in a second study (RCC Notox, 1991) conjuctival redness in three of three animals. These changes were transient (resolved within 72 hours) and were below the threshold criteria for classification for eye irritancy. The third study (Laboratoire de Biotoxicologie, Roquette Freres,1997), showed no eye irritancy.
Justification for selection of eye irritation endpoint:
The key study showed conjuctival redness and corneal opacity. Supporting studies showed lesser or no irritant responses.
Effect level: empty Endpoint conclusion: Adverse effect observed
Justification for classification or non-classification
The test substance is not classified for skin or eye irritation, according to EU CLP criteria (Regulation No.1271/2008).
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.
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