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EC number: 250-774-0 | CAS number: 31714-55-3
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 10 July 1989 - 24 July 1989
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- Adopted 24 February 1987
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Hydrogen bis[1-[(5-chloro-2-hydroxyphenyl)azo]-2-naphtholato(2-)]chromate(1-)
- EC Number:
- 250-774-0
- EC Name:
- Hydrogen bis[1-[(5-chloro-2-hydroxyphenyl)azo]-2-naphtholato(2-)]chromate(1-)
- Cas Number:
- 31714-55-3
- Molecular formula:
- C32H19Cl2CrN4O4
- IUPAC Name:
- [1-{[5-chloro-2-(hydroxy-kappaO)phenyl]diazenyl}-2-naphtholato(2-)-kappaO]{1-[(5-chloro-2-hydroxyphenyl)diazenyl]-2-naphtholato-kappaO}chromium
- Test material form:
- solid: particulate/powder
- Details on test material:
- Storage: ambient temperature in darkness
Appearance: Black powder
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- - Source: Froxfield Farms (U.K.) Ltd., Petersfield, Hampshire, England and A. Smith, Warlingham, Surrey, England
- Age at study initiation: 9 -12 weeks.
- Weight at study initiation: at least 2.2 - 2.8 kg
- Housing: Animals were housed individually in metal cages with perforated floors.
- Diet: Free access to SDS Standard Rabbit Diet
- Water: Free access to tap water.
ENVIRONMENTAL CONDITIONS
- Temperature: approx 19°C
- Humidity: between 30% - 70%
- Air changes (per hr): approx 19 air changes
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: One eye of each animal remained untreated and served as the reference control.
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: Approximately 30mg of Bontron S-34 (volume 0.1mL) - Duration of treatment / exposure:
- Single instillation on day 1.
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 3 females
- Details on study design:
- STUDY DESIGN
Eyes were examined prior to instillation.
Approximately 30mg of Bontron S-34 was applied in the lower everted lid. The eyelid was subsequently held together for one second.
OBSERVATIONS
Observations were aided by a handheld torch
The eyes of each animal were examined approximately 1 hour after instillation and 1, 2,3, 4,and 7 days thereafter.
The irritation scores and a description of all other (local) effects were recorded. The irritation was assessed according to the guideline.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- Mild conjunctival inflammation, Irritation score = 1 (Some blood vessels definitely hyperaemic (injected)), was only observed one hour after instillation in all three animals. No corneal damage or iridial inflammation was seen throughout the observation period.
Applicant's summary and conclusion
- Interpretation of results:
- other: Non irritating
- Conclusions:
- In an eye irritation study with rabbits, it was shown that Bontron S-34 only elicited transient mild conjunctival irritation in the first hour after instillation. Effects were fully reversible within 1 day. In conclusion Bontron S-34 is not irritating to the eye and does not need to be classified according to GHS criteria.
- Executive summary:
Bontron S-34 was evaluated for eye irritation on three female New Zealand White rabbits performed according to OECD test guideline 405 and GLP princples. Approximately 30mg was applied on the lower everted lid of the animal. Observations occurred one hour after application of the substance and subsequently on the 1st, 2nd 3rd 4th and 7th day. The eye showed mild conjuctival inflammation (score = 1) in all three animals 1 hour after application, only thereafter no clinical signs were reported. All effects observed were fully reversible within 1 day. Based on the results Bontron S-34 is concluded not to be an eye irritant and is not classified according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2015) (including all amendments) and Regulation (EC) No 1272/2008 on classification, labelling and packaging of items and mixtures (including all amendments).
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