Registration Dossier
Registration Dossier
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EC number: 229-880-6 | CAS number: 6805-41-0
Eye irritation
Administrative data
- Endpoint:
- eye irritation, other
- Remarks:
- in vivo test
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1994
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Short-term and Long-term toxicology group Final Report: Acute eye irritation/corrosivity 1979/12/31 pag. 40
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Escin
- EC Number:
- 229-880-6
- EC Name:
- Escin
- Cas Number:
- 6805-41-0
- Molecular formula:
- C110H172O48
- IUPAC Name:
- (2S,3S,4S,5R,6R)-6-{[(3S,4S,4aR,6aR,6bS,8R,8aR,9R,10R,12aS,14aR,14bR)-9-(acetyloxy)-8-hydroxy-4,8a-bis(hydroxymethyl)-4,6a,6b,11,11,14b-hexamethyl-10-[(2-methylbutanoyl)oxy]-1,2,3,4,4a,5,6,6a,6b,7,8,8a,9,10,11,12,12a,14,14a,14b-icosahydropicen-3-yl]oxy}-4-hydroxy-3,5-bis({[(2S,3R,4S,5S,6R)-3,4,5-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxy})oxane-2-carboxylic acid; (2S,3S,4S,5R,6R)-6-{[(3S,4S,4aR,6aR,6bS,8R,8aR,9R,10R,12aS,14aR,14bR)-9-(acetyloxy)-8-hydroxy-4,8a-bis(hydroxymethyl)-4,6a,6b,11,11,14b-hexamethyl-10-{[(2E)-2-methylbut-2-enoyl]oxy}-1,2,3,4,4a,5,6,6a,6b,7,8,8a,9,10,11,12,12a,14,14a,14b-icosahydropicen-3-yl]oxy}-4-hydroxy-3,5-bis({[(2S,3R,4S,5S,6R)-3,4,5-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxy})oxane-2-carboxylic acid
- Test material form:
- solid
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- 6 White Rabbit (New Zealand). Weight 2-3 kg. Sex: male
Each rabbit has been housing in stainless steel cages of mm 450x500x80 with automatic washing cycle.
Animals have been feeding with pellet complete diet of authorized breeding.
Animals have been driinking water from local network filtred.
Housing: Temperature 20+-2°C Hygrometry: 55+-15% H.R. Air changed at least 25 times for hour and mantained at a higher pressure than the outside atmosphere. Artificial lighting: 12 h/day.
Test system
- Vehicle:
- water
- Controls:
- other: each animal serving as its own control
- Amount / concentration applied:
- The test material (0.1 mL/animal of a solution at 5% p/v)
- Duration of treatment / exposure:
- single dose
- Observation period (in vivo):
- 1 - 24 - 48 - 72 hours
- Number of animals or in vitro replicates:
- 6
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- other: 1
- Remarks:
- h
- Basis:
- other: mean daily scores
- Time point:
- other: 1
- Score:
- 17.33
- Max. score:
- 17.33
- Reversibility:
- not fully reversible within: 7
- Remarks:
- days
- Irritation parameter:
- overall irritation score
- Basis:
- other: mean daily scores
- Time point:
- 24 h
- Score:
- 12
- Max. score:
- 12
- Reversibility:
- not fully reversible within: 7
- Remarks:
- days
- Irritation parameter:
- overall irritation score
- Basis:
- other: mean daily scores
- Time point:
- 48 h
- Score:
- 5
- Max. score:
- 5
- Reversibility:
- not fully reversible within: 7
- Remarks:
- days
- Irritation parameter:
- overall irritation score
- Basis:
- other: mean daily scores
- Time point:
- 72 h
- Score:
- 4.67
- Max. score:
- 4.67
- Reversibility:
- not fully reversible within: 7
- Remarks:
- days
- Irritation parameter:
- overall irritation score
- Basis:
- other: mean daily scores
- Time point:
- 7 d
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 7
- Remarks:
- days
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- Warning, Eye Irrit. 2, Causes serious eye irritation.
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