Registration Dossier
Registration Dossier
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EC number: 265-499-1 | CAS number: 65138-66-1
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
- Justification for type of information:
- Data is from safety assessment report
Data source
Reference
- Reference Type:
- secondary source
- Title:
- Risk Management Options Analysis for Di Ethyl Hexyl Terephthalate (DEHTP)
- Author:
- European Chemicals Agency (ECHA)
- Year:
- 2 016
- Bibliographic source:
- Risk Management Options Analysis for Di Ethyl Hexyl Terephthalate (DEHTP); European Chemicals Agency (ECHA); January, 2016
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Principles of method if other than guideline:
- An eye irritation study of chemical 1,4-bis(2-ethylhexyl) benzene-1,4-dicarboxylate (CAS No: 6422-86-2) was conducted male and female New Zealand white rabbits to assess its eye irritation potential in accordance with OECD guideline 405.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- 1,4-bis(2-ethylhexyl) benzene-1,4-dicarboxylate
- Cas Number:
- 6422-86-2
- Molecular formula:
- C24H38O4
- IUPAC Name:
- 1,4-bis(2-ethylhexyl) benzene-1,4-dicarboxylate
- Test material form:
- liquid
- Details on test material:
- - Name of test material (as cited in study report): Di Ethyl Hexyl Terephthalate (DEHTP)
- Molecular formula: C24H38O4
- Molecular weight: 1221.16 g/mol
- Substance type: organic
- Physical state: liquid
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): Di Ethyl Hexyl Terephthalate (DEHTP)
- Molecular formula: C24H38O4
- Molecular weight: 1221.16 g/mol
- Substance type: organic
- Physical state: liquid
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- No data available
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
- 100%
- Duration of treatment / exposure:
- 4 hours
- Observation period (in vivo):
- 72 hours
- Duration of post- treatment incubation (in vitro):
- No data available
- Number of animals or in vitro replicates:
- 3 (1 male/2 females)
- Details on study design:
- No data available
Results and discussion
In vivo
Results
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 72 h
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No corneal opacity or iritis was observed during the study. Conjunctivitis and redness were reported up to 48 hours after administration. All reported effects were fully reversible within 72 hours.
Applicant's summary and conclusion
- Interpretation of results:
- other: Not irritating
- Conclusions:
- The test chemical 1,4-bis(2-ethylhexyl) benzene-1,4-dicarboxylate (CAS No: 6422-86-2) can be considered as not irritating to the New Zealand white rabbits’ eye
- Executive summary:
An eye irritation study of chemical1,4-bis(2-ethylhexyl) benzene-1,4-dicarboxylate (CAS No: 6422-86-2) was conducted in three (1 male and 2 female) New Zealand white rabbits to assess its eye irritation potential in accordance with OECD guideline 405.
The undiluted1,4-bis(2-ethylhexyl) benzene-1,4-dicarboxylate was installed into the one eye of each rabbit for 4 hours and observations were made for 72 hours following application.
No corneal opacity or iritis was observed during the study. Conjunctivitis and redness were reported up to 48 hours after administration. All reported effects were fully reversible within 72 hours.
Since all the effects were cleared within 72 hours, the chemical 1,4-bis(2-ethylhexyl) benzene-1,4-dicarboxylate (CAS No: 6422-86-2) can be considered asnot irritatingto theNew Zealand whiterabbits’ eye.
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