Registration Dossier
Registration Dossier
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EC number: 298-577-9 | CAS number: 93819-94-4
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 1983
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study conducted on readacross substance. However reliability and applicability high, supported by Category documentation
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 983
- Report date:
- 1983
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Section 1500.42-Hazardous Substance and Articles, Administration and Enforcement Regulations, Federal Register, Vol 38, No. 187, P 27019, 27 September 1973.
- GLP compliance:
- yes
Test material
- Reference substance name:
- Phosphorodithioic acid, mixed O,O-bis(1,3-dimethylbutyl and iso-Pr) esters, zinc salts
- EC Number:
- 283-392-8
- EC Name:
- Phosphorodithioic acid, mixed O,O-bis(1,3-dimethylbutyl and iso-Pr) esters, zinc salts
- Cas Number:
- 84605-29-8
- IUPAC Name:
- zinc bis[O-(1,3-dimethylbutyl) O-isopropyl dithiophosphate]
- Details on test material:
- Undiluted liquid
Constituent 1
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.66
- Reversibility:
- not fully reversible within: 21 days
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.17
- Reversibility:
- not fully reversible within: 21 days
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2.05
- Reversibility:
- not fully reversible within: 21 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 3.1
- Reversibility:
- not fully reversible within: 21 days
- Irritant / corrosive response data:
- The eyes were examined at 1, 2, 3, 4, 7, 14, and 21 days following instillation in accordance with the Draize method. The mean (24, 48, and 72 hours) cornea opacity, iritis, conjunctival redness and conjunctival edema scores were 1.66, 0.17, 2.05, and 3.1 respectively. Corneal opacity, iritis, conjunctivae redness and chemosis did not resolve by 21 days.
Any other information on results incl. tables
Cornea score:
1.66 of max. 4 (mean) (Time point: 24, 48 72 hours) (not reversible) (Effects did not clear in 4/6 animals at 21 days)
Iris score:
0.17 of max. 2 (mean) (Time point: 24, 48, 72 hours) (not reversible) (Effects were not clear in 2/6 animals at 21 days)
Conjunctivae score:
2.05 of max. 3 (mean) (Time point: 24, 48, 72 hours) (not reversible) (Effects did not clear in 5/6 animals at 21 days)
Chemosis score:
3.1 of max. 4 (mean) (Time point: 24, 48, 72 hours) (not reversible) (Effects did not clear in 6/6 animals at 21 days)Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye)
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of this study, the test material caused ocular irritation that persisted through day 21. In accordance with Directive 67/548/EEC and EU CLP (Regulation (EC) No. 1272/2008) classification of this substance is required for eye irritation. The results from this substance can be read across to the registration substance.
- Executive summary:
The substance was instilled into the conjunctival sac of six New Zealand white rabbits. The eyes were examined at 1, 2, 3, 4, 7, 14, and 21 days following instillation in accordance with the Draize method. The mean (24, 48, and 72 hours) cornea opacity, iritis, conjunctival redness and conjunctival edema scores were 1.66, 0.17, 2.05, and 3.1 respectively. Corneal opacity, iritis, conjunctivae redness and chemosis did not resolve by 21 days. Under the conditions of this study, the test material caused ocular irritation that persisted through day 21.
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