Registration Dossier
Registration Dossier
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EC number: 213-485-0 | CAS number: 957-68-6
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- June 26, 1978 - June 29, 1978
- Reliability:
- 2 (reliable with restrictions)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1978
Materials and methods
Test guideline
- Guideline:
- other: FDA guideline (Federal register 38, no. 187, 27.9.1973, p 27019)
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Automatically generated during migration to IUCLID 6, no data available
- IUPAC Name:
- Automatically generated during migration to IUCLID 6, no data available
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): 7-Aminocephalosporansäure (7-ACS)
- Physical state: creme coloured powder
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- Himalayan
- Details on test animals or tissues and environmental conditions:
- Animals:
Albino-Himalayan (Hoe:HIMK (SPFWiga))
Number: 6
Animal maintenance:
Cages: individual caging
Feed: ERKA 8300, ad libitum
Water: tap water, ad libitum
Test system
- Vehicle:
- other: propane diol
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 100 mg of the test substance in 0.12 ml propane diol each were applied once into the conjunctival sack of the left eye.
- Duration of treatment / exposure:
- 24 h
- Observation period (in vivo):
- 72
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- 100 mg of the test substance in 0.12 ml propane diol each were applied once into the conjunctival sack of the left eye. The right eye was the negative control. The evaluation of the irritating effect was carried out 1, 7, 24, 48 and 72 hours after application. 24 hours after application the eyes were washed with physiologic sodium chloride solution.
Results and discussion
In vivo
Results
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 7 hours
- Score:
- 23
- Reversibility:
- not specified
Applicant's summary and conclusion
- Interpretation of results:
- slightly irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: US CPSC / US FDA
- Conclusions:
- According to the FDA guideline the substance 7-ACS has to be classified as slightly irritant.
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