Registration Dossier
Registration Dossier
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EC number: 213-497-6 | CAS number: 959-26-2
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- The basis for this read-across approach is that the target substance is expected to undergo transformation into terephthalic acid (202-830-0; 100-21-0) and ethane-1,2-diol (203-473-3; 107-21-1). The toxicity of the metabolites will accurately predict the toxicity of the bis(2-hydroxyethyl)terephthalate (BHET; 959-26-2; 213-497-6). Refer to the JUSTIFICATION FOR READ-ACROSS OF TOXICOLOGICAL INFORMATION in Section 13 of this dossier for further details.
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- read-across: supporting information
- Reason / purpose for cross-reference:
- read-across source
Reference
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Guideline:
- other: Method not reported, Abbreviated Primary Eye Irritation Study
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- Not Reported
- Controls:
- not specified
- Irritation parameter:
- other: Primary eye Irritation
- Basis:
- mean
- Time point:
- other: not reported
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- not determinable because of methodological limitations
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- not determinable because of methodological limitations
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- not determinable because of methodological limitations
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- not determinable because of methodological limitations
- Irritant / corrosive response data:
- Virtually no irritation was observed
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Terephthalic acid is not irritating to the eye.
- Reason / purpose for cross-reference:
- read-across source
Reference
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Remarks:
- The work of this group pre-dates range finding toxicity guidelines and provided much of the basis for their development. Their results are cited by many subsequent authoritative review bodies and are often found in SIDS and SIAR documents via secondary references. Therefore, these results are deemed reliable.
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- 5 rabbits received instillation of 0.5mL of ethane-1,2-diol (203-473-3; 107-21-1). Eye irritation was scored 15-24 h later.
- GLP compliance:
- no
- Specific details on test material used for the study:
- Reported as: Ethylene glycol
- Species:
- rabbit
- Strain:
- not specified
- Vehicle:
- water
- Controls:
- yes
- Amount / concentration applied:
- 0.5mL
- Duration of treatment / exposure:
- 18-24 h
- Observation period (in vivo):
- Eye scored 18-24 h after application
- Number of animals or in vitro replicates:
- 5
- Details on study design:
- - Preparation of test substance: Test substance was prepared by mixing of test substance with water.
- Amount of active substance instilled: 0.5 mL
- Removal of test substance: unwashed
- Duration of exposure: ca. 24 h
- Post exposure period: No
- Clinical signs: No data
- Examination time points: 18-24 h after application
- Further remarks: Study on 180 different substances; TS applied to the center of the cornea (lids retracted) in different concentrations and volumes and scored 18-24 h later, usually 5 rabbits per group; symptoms scored before fluorescein staining (cornea opacity, max 6 points; iritis, max 2 points; keratoconus 6 points) and after staining (necrosis of cornea evaluated, max. 6 points); max. of 20 points possible (6+6+2+6).
A level of totally 5 points (mean of 5 animals) is representative of severe injury.
10 injury grades (max. 10: sodium hydroxide, 0.005 ml of a 1% solution resulted in > 5 points).
- Irritation parameter:
- other: injury
- Basis:
- mean
- Time point:
- other: 18-24 h
- Score:
- >= 0 - <= 1
- Max. score:
- 5
- Reversibility:
- other: Not relevant
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- not determinable because of methodological limitations
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- not determinable because of methodological limitations
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- not determinable because of methodological limitations
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- not determinable because of methodological limitations
- Irritant / corrosive response data:
- Application resulted in injury grade 1: 0.5 mL undiluted ethylene glycol yielded scores of 0 to 1.0 points.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Application of 0.5 mL undiluted ethylene glycol resulted in a numerical injury score of 0-1 out of a maximum of 5. This indicates minimal to no eye irritation.
Data source
Materials and methods
Test material
- Reference substance name:
- Bis(hydroxyethyl) terephthalate
- EC Number:
- 213-497-6
- EC Name:
- Bis(hydroxyethyl) terephthalate
- Cas Number:
- 959-26-2
- Molecular formula:
- C12H14O6
- IUPAC Name:
- bis(hydroxyethyl) terephthalate
- Test material form:
- solid
Constituent 1
- Specific details on test material used for the study:
- Bis(2-hydroxyethyl) terephthalate value is read-across from supporting terephthalic acid (202-830-0; 100-21-0) and ethane-1,2-diol (203-473-3; 107-21-1) data.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- not determinable
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- not determinable
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- not determinable
- Irritation parameter:
- overall irritation score
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- Neither the terephthalic acid (202-830-0; 100-21-0) nor ethane-1,2-diol (203-473-3; 107-21-1) metabolites are irritating to the eye. Therefore, it was predicted that bis(2-hydroxyethyl)terephthalate (BHET; 959-26-2; 213-497-6) will not be irritating to the eye.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Neither the terephthalic acid (202-830-0; 100-21-0) nor ethane-1,2-diol (203-473-3; 107-21-1) metabolites are irritating to the eye. Therefore, it was predicted that bis(2-hydroxyethyl)terephthalate (BHET; 959-26-2; 213-497-6) will not be irritating to the eye.
- Executive summary:
The in vivo eye irritation of terephthalic acid was assessed in rabbits in a GLP-compliant abbreviated primary eye irritation study. Virtually no irritation was observed. Carpenter and Smyth (1946) assessed the in vivo eye irritation of ethylene glycol in a non-GLP-complaint study. Minimal to no eye irritation was reported following application of 0.5 mL of undiluted ethylene glycol. The target substance was expected to undergo metabolism by esterases into the two source substances. As in vivo testing for each source substance reported no eye irritation, it was predicted that BHET will not be irritating to the eye.
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