Registration Dossier
Registration Dossier
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EC number: 212-783-8 | CAS number: 868-85-9
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: see 'Remark'
- Remarks:
- Comparable to guideline study with restrictions (No GLP study. Only 2 animals used. Reading at 72 hours was not performed. No information about environmental and housing conditions). Adopted according to OECD SIDS (public available peer reviewed source). The original source is available and has been reviewed.
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
- Reference Type:
- secondary source
- Title:
- Dimethyl phosphonate - CAS No: 868-85-9 - SIDS Initial Assessment Report
- Author:
- OECD
- Year:
- 2 004
- Bibliographic source:
- UNEP Publications
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- No GLP study. Only 2 animals used. Reading at 72 hours was not performed. No information about environmental and housing conditions
- GLP compliance:
- no
- Remarks:
- GLP was not mandatory at the time of the study
Test material
- Reference substance name:
- Dimethyl phosphonate
- EC Number:
- 212-783-8
- EC Name:
- Dimethyl phosphonate
- Cas Number:
- 868-85-9
- Molecular formula:
- C2H7O3P
- IUPAC Name:
- dimethyl phosphonate
- Details on test material:
- - Name of test material (as cited in study report): dymethyl phosphite
- Analytical purity: no data
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 3-4 kg
- Housing: individual housing
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- Amount applied: 0.1 mL
- Observation period (in vivo):
- up to 7 days
- Number of animals or in vitro replicates:
- 2
- Details on study design:
- SCORING SYSTEM: Draize score
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- Reddening of the conjunctiva (grade 2) was observed 1h after treatment; no other effects. Effects reversible in 5 days.
Any other information on results incl. tables
Reading at 72 hours was not performed. The same scores assumed as for 48h time point (worst case).
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Executive summary:
In an eye irritation study, 0.1 mL of test substance was instilled into the conjunctival sac of one eye of two male young adult New Zealand White rabbits, with a method similar to OECD guideline 405 with deviations (No GLP study. Only 2 animals used. Reading at 72 hours was not performed. No information about environmental and housing conditions). Animals were observed for 7 days. Irritation was scored according to the method of Draize. Reddening of the conjunctiva (grade 2) was observed 1h after treatment; no other effects were observed. Effects were reversible within 5 days. Based on the study results, it can be concluded that dimethyl phosphonate is not irritating to eyes according to DSD and CLP criteria.
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