Registration Dossier
Registration Dossier
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EC number: 284-634-5 | CAS number: 84961-45-5 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Ceratonia siliqua. Leguminosae.
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 72 hours
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Results were given as an average, and not specified for each individual animal
- Remarks:
- anticipated data should be good.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Draize 1944 method
- Version / remarks:
- none specified
- Deviations:
- not specified
- GLP compliance:
- not specified
Test material
- Test material form:
- not specified
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- physiological saline
- Amount / concentration applied:
- 0.5 g/test site
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- Skin irritation was assessed using the Draize method at 4.5, 24, 48 and 72 hours
- Number of animals:
- 6
- Details on study design:
- Six New Zealand white rabbits were treated topically with 0.5 g/test site of Carob gum. The test material was moistened with saline and placed in contact with shaved intact skin for 4 hours under a semi-occlusive wrap. Skin irritation was assessed using the Draize method at 4.5, 24, 48 and 72 hours. Carob gum was found to be minimally irritating to the rabbit skin.
Results and discussion
In vivo
Results
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 8
- Reversibility:
- not specified
- Remarks on result:
- probability of weak irritation
- Irritant / corrosive response data:
- Results were given as an average.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Executive summary:
Carob gum was found to be non irritating to the rabbit skin.
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