Registration Dossier
Registration Dossier
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EC number: 203-896-3 | CAS number: 111-69-3
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:
- other: Acceptable test method, scoring and assessment of the findings based on the acknowledged Draize score.
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 959
- Report date:
- 1959
- Reference Type:
- publication
- Title:
- Zur Toxizitaet der Nitrile (Tierexperimentelle Untersuchungsergebnisse und werksaerztliche Erfahrungen in 15 Jahren
- Author:
- Zeller H., Hofmann HT. et al.
- Year:
- 1 969
- Bibliographic source:
- Zentralblatt fuer Arbeitsmedizin und Arbeitsschutz, Band 19, Heft 8, 225-238
- Reference Type:
- review article or handbook
- Title:
- 1,4-Dicyanobutan, Nr.100
- Author:
- Berufsgenossenschaft der chemischen Industrie
- Year:
- 1 989
- Bibliographic source:
- Toxikologische Bewertung, Ausgabe 02/89
Materials and methods
- Principles of method if other than guideline:
- see details in remarks on material and methods.
- GLP compliance:
- no
Test material
- Reference substance name:
- Adiponitrile
- EC Number:
- 203-896-3
- EC Name:
- Adiponitrile
- Cas Number:
- 111-69-3
- Molecular formula:
- C6H8N2
- IUPAC Name:
- hexanedinitrile
- Details on test material:
- - Name of test material (as cited in study report): Adipinsaeuredinitril
- Physical state: liquid
- Analytical purity: not specified
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: BASF internal breed
- Weight at study initiation: 2,56 and 2,71 kg
- Diet (e.g. ad libitum): Altromin-MS
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The adjacent eye served as saline control.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0,05 ml
- Concentration (if solution): undiluted - Duration of treatment / exposure:
- 24 h
- Observation period (in vivo):
- 72 h
- Number of animals or in vitro replicates:
- 2
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): Eyes were not rinsed
SCORING SYSTEM: The original BASF grading was converted into the numerical grading according to the OECD Draize system.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.8
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- other: See table below for results on each individual animal
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: no effects
- Remarks on result:
- other: See table below for results on each individual animal
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- fully reversible within: 24 h
- Remarks on result:
- other: See table below for results on each individual animal
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Remarks on result:
- other: See table below for results on each individual animal
Any other information on results incl. tables
Findings animal 1/2:
| Time | Opacity | Iritis | Erythema | Chemosis | ||
| 10 min | 0/0 | 0/0 | 2/1 | 0/0 | ||
| 1 h | 1/1 | 0/0 | 1/1 | 0/0 | ||
| 3 h | 2/1 | 0/0 | 1/2 | 0/0 | ||
| 24 h | 2/1 | 0/0 | 0/0 | 0/0 | ||
| 48 h | 1/1 | 0/0 | 0/0 | 0/0 | ||
| 72 h | 0/0 | 0/0 | 0/0 | 0/0 |
Mean values over 24 h, 48 h and 72 h:
Animal 1: Opacity: 1; Iritis: 0; Erytema: 0; Chemosis: 0;
Animal 2: Opacity: 0,6; Iritis: 0; Erytema: 0; Chemosis: 0;
The application of the test substance caused slight to moderate corneal opacity up to 48 h, and slight to moderate erythema up to 3 h post treatment. All effects were fully reversible within 72 h.
The original BASF grading was converted into the numerical grading according to the OECD Draize system.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information
- Conclusions:
- Classification: not irritating
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