Registration Dossier
Registration Dossier
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EC number: 940-667-3 | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- Test phase 2013-05-13 to 2013-04-08. Report complete 2013-06-14
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Meets the criteria for classification as Reliable with restrictions according to Klimisch et al (1997) This read-across is based on the hypothesis that the Source and Target substances will have similar toxicological and ecotoxicological properties due to their close physical-chemical and structural similarities. For example, both the Source and Target substances are monoconstituents which share structural similarities and contain the same functional groups (thio ether, sulfonate, vicinal nitrile groups).
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
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
- Details on test material:
- See confidential details on test material section
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Harlan Laboratories UK Ltd, Leicestershire, UK
- Age at study initiation: 12-20 weeks
- Weight at study initiation:2.40 and 3.07 kg
- Housing: Individually housed in suspended cages
- Diet (e.g. ad libitum): Free access to food throughout the study
- Water (e.g. ad libitum): Free access to mains drinking water throughout the study
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23
- Humidity (%): 30-70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: a 0.1ml volume of the test material which was found to weigh approximately 74mg as measured by gently compacting the required volume into an adapted syringe - Duration of treatment / exposure:
- single application
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 2
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: None
SCORING SYSTEM: Initial pain reaction assessed using a six point scale.Assessment of ocular damage at 1h, 24, 48 & 72h according to the numerical evaluation given in Draize (Draize, J.H, 1977). A modified version of the system described by Kay J.H. and Calandra J.C. (1962) was used to classify the ocular irritancy potential of the test material.
TOOL USED TO ASSESS SCORE: light source from a standard opthalmoscope
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 73100
- Time point:
- other: highest score at 24, 48 & 72h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 73154
- Time point:
- other: highest score at 24, 48 & 72h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal: 73100
- Time point:
- other: highest score at 24, 48 & 72h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal: 73154
- Time point:
- other: highest score at 24, 48 & 72h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 48h
- Irritation parameter:
- chemosis score
- Basis:
- animal: 73100
- Time point:
- other: highest score at 24, 48 & 72h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- chemosis score
- Basis:
- animal: 73154
- Time point:
- other: highest score at 24, 48 & 72h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- other: redness
- Basis:
- animal: 73100
- Time point:
- other: highest score at 24, 48 & 72h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- other: redness
- Basis:
- animal: 73154
- Time point:
- other: highest score at 24, 48 & 72h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- overall irritation score
- Basis:
- animal: 73100
- Time point:
- other: 1h
- Score:
- 12
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- overall irritation score
- Basis:
- animal: 73154
- Time point:
- other: 1h
- Score:
- 12
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- overall irritation score
- Basis:
- animal: 73100
- Time point:
- other: 24h
- Score:
- 10
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- overall irritation score
- Basis:
- animal: 73154
- Time point:
- other: 24h
- Score:
- 15
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- overall irritation score
- Basis:
- animal: 73100
- Time point:
- other: 48h
- Score:
- 6
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- overall irritation score
- Basis:
- animal: 73154
- Time point:
- other: 48h
- Score:
- 6
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- overall irritation score
- Basis:
- animal: 73154
- Time point:
- other: 72h
- Score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- overall irritation score
- Basis:
- animal: 73100
- Time point:
- other: 7 days
- Score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- overall irritation score
- Basis:
- animal: 73154
- Time point:
- other: 7 days
- Score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- overall irritation score
- Basis:
- animal: 73100
- Time point:
- other: 14 days
- Score:
- 0
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- overall irritation score
- Basis:
- animal: 73154
- Time point:
- other: 14 days
- Score:
- 0
- Reversibility:
- fully reversible within: 14 days
- Irritant / corrosive response data:
- A single application of the test material to the non-irrigated eye of two rabbits produced iridial inflammation, moderate conjunctival irritation and petechial haemorrhage on the nictitating membrane. Both treated eyes appeared normal at the 14 day observation.
Any other information on results incl. tables
The Source substance has a comprehensive data set generated for a REACH Annex VIII registration and this along with its similarity to the Target substance are consider sufficient to consider the read-across an appropriate adaptation to the standard information requirements of Annex VII of the REACH regulation for the Target substance in accordance with the provisions of Annex XI, 1.5 of the REACH regulation. Please see the attached document in the Background Material section for further details on the justification of the read across approach.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The source test material produced a maximum group mean score of 12.5 and was classified as a mild irritant (Class 4 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra classification system.
The source test material did not meet the criteria for classification as irritant according to EU labelling regulations Commission Directive 2001/59/EC for Classification and Labelling of Dangerous Substances or Regulation (EC) No. 1272/2008, relating to the Classification, Labelling and Packaging of Substances and Mixtures.
The Source substance has a comprehensive data set generated for a REACH Annex VIII registration and this along with its similarity to the Target substance are consider sufficient to consider the read-across an appropriate adaptation to the standard information requirements of Annex VII of the REACH regulation for the Target substance in accordance with the provisions of Annex XI, 1.5 of the REACH regulation. Please see the attached document in the Background Material section for further details on the justification of the read across approach. - Executive summary:
Introduction
This study was performed to assess the irritancy potential of the source test material to the eye of the New Zealand White Rabbit. The study was designed to be compatible with the following guidelines:
- OECD Guidelines for the Testing of Chemicals No. 405 'Acute Eye Irritation/Corrosion' (adopted 02 October 2012)
- Method B5 Acute Toxicity (Eye Irritation) of Commission Regulation (EC) No. 440/2008.
This read-across is based on the hypothesis that the Source and Target substances will have similar toxicological and ecotoxicological properties due to their close physical-chemical and structural similarities. For example, both the Source and Target substances are monoconstituents which share structural similarities and contain the same functional groups (thio ether, sulfonate, vicinal nitrile groups).
Results
A single application of the source test material to the non-irrigated eye of two rabbits produced iridial inflammation, moderate conjunctival irritation and petechial haemorrhage on the nictitating membrane. Both treated eyes appeared normal at the 14 day observation.
Conclusion
The source test material produced a maximum group mean score of 12.5 and was classified as a mild irritant (Class 4 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra classification system. The source test material did not meet the criteria for classification as irritant according to EU labelling regulations Commission Directive 2001/59/EC for Classification and Labelling of Dangerous Substances or Regulation (EC) No. 1272/2008, relating to the Classification, Labelling and Packaging of Substances and Mixtures.
The Source substance has a comprehensive data set generated for a REACH Annex VIII registration and this along with its similarity to the Target substance are consider sufficient to consider the read-across an appropriate adaptation to the standard information requirements of Annex VII of the REACH regulation for the Target substance in accordance with the provisions of Annex XI, 1.5 of the REACH regulation. Please see the attached document in the Background Material section for further details on the justification of the read across approach.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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