Registration Dossier
Registration Dossier
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EC number: 251-646-7 | CAS number: 33703-08-1
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
- Report date:
- 1984
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- no
Test material
- Reference substance name:
- Diisononyl adipate
- EC Number:
- 251-646-7
- EC Name:
- Diisononyl adipate
- Cas Number:
- 33703-08-1
- Molecular formula:
- C24H46O4
- IUPAC Name:
- 1,6-bis(7-methyloctyl) hexanedioate
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- purity: >99% (GC)
test substance name: Di-iso-nonyladipat
Charge: 14626
Test animals / tissue source
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Gaukler; D-6050 Offenbach / Main, Germany
- Age at study initiation: no data
- Weight at study initiation: male: 2.79 kg; females (mean): 3.28 kg
- Housing: individual
- Diet: Ovator Solikanin 4 mm, about 130 g per animal per day
- Water: about 250 ml tap water per animal per day
- Acclimation period: 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12 h
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.1 ml
- Duration of treatment / exposure:
- Single application to the conjuctival sac of the eyelid; the substance is not washed out.
- Observation period (in vivo):
- 72 h
- Number of animals or in vitro replicates:
- 3 (1 male, 2 females)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 1-72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 1-72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 1-72 h
- Score:
- 0.83
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 1-72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- Primary irritation index equals 1
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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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