Registration Dossier
Registration Dossier
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EC number: 944-856-1 | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- other: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- June 02, 1975
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Remarks:
- The test was conducted by means of Read Across approach. The reliability of the source study report is 2. Further information was attached at section 13
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 975
- Report date:
- 1975
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: "Hazardous Substances Regulations" under the U.S.A. Federal Hazardous Substances Labelling Act Sect. 191.12 (February 1965)
- Deviations:
- yes
- Remarks:
- not specified
- GLP compliance:
- no
Test material
- Reference substance name:
- Acid Red DAH:1 - Similar Substance 01
- IUPAC Name:
- Acid Red DAH:1 - Similar Substance 01
- Test material form:
- not specified
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 10 - 13 weeks
- Weight at study initiation: 2.90 Kgs. (♂) and 2.21 Kgs. (♀)
- Housing: single housed in semi-barrier system.
- Diet: A commercial irradiated diet (Styles-Oxbid) was fed ad libitum.
- Water: Sterile filtered water was available at all times.
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C. (± 1°)
- Humidity (%):50-70%
- Photoperiod (hrs dark / hrs light): Animals were exposed to artificial light for 10 hours daily from 08.00 - 18.00 hours.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit):100 mg - Duration of treatment / exposure:
- single instillation into the conjunctival sac
- Observation period (in vivo):
- 1, 6, 24, 48 and 72 hours after application
- Number of animals or in vitro replicates:
- 2 females and 4 males
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): After 30 seconds the compound was, as far as possible, flushed out of the eyes of three of the rabbits with warm water for 1 minute.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 11
- Time point:
- other: 24, 48, 72 hours
- Score:
- ca. 1
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 13
- Time point:
- other: 24, 48, 72 hours
- Score:
- ca. 1.33
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 12
- Time point:
- other: 24, 48, 72 hours
- Score:
- ca. 1.33
- Max. score:
- 3
- Reversibility:
- fully reversible
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP criteria not met
- Conclusions:
- Not irritant.
- Executive summary:
Method
The substance was tested for eye irritation according to "Hazardous Substances Regulations" under the U.S.A. Federal Hazardous Substances Labelling Act Sect. 191.12 (February 1965).
Results
The eyes of the experimental animals were examined and found normal prior to the test. 100 mg of the test compound were instilled into the conjunctival sac of the left eye. The eyelids were then held closed for 1 second. . The right eye served as a control. After 30 seconds the compound was, as far as possible, flushed out of the eyes of three of the rabbits with warm water for 1 minute. The rabbits were examined 1, 6, 24, 48 and 72 hours after application of the test compound and for any further period that was considered necessary. A slight to mild conjunctival reaction was seen in all treated eyes one hour after application of the compound. All eyes were normal by 48 hours (washed) and 72 hours (unwashed).
Results
Non irritant.
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