Registration Dossier
Registration Dossier
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EC number: 242-894-7 | CAS number: 19224-26-1
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Remarks:
- in vivo study performed
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 21 July 1997 - 26 July 1997
- Reliability:
- 1 (reliable without restriction)
- Justification for type of information:
- A discussion and report on the read across strategy is given as an attachment in IUCLID Section 13.
Cross-reference
- Reason / purpose for cross-reference:
- read-across: supporting information
Reference
- Endpoint:
- eye irritation: in vivo
- Remarks:
- in vivo study performed
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 21 July 1997 - 26 July 1997
- Reliability:
- 1 (reliable without restriction)
- Justification for type of information:
- A discussion and report on the read across strategy is given as an attachment in IUCLID Section 13.
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 798.4500 (Acute Eye Irritation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- Note - study report refers to the guideline as number 404 "Acute Eye Irritation / corrosion", adopted 24 February 1987.
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: JMAFF, Requirements for Safety Evaluation of Agricultural Chemicals and Testing Guidelines for Toxicology Studies, Primary Eye Irritation Study, 59 NohSan No 4200, Agricultural Production Bureau, January 28, 1985.
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Harlan Interfauna UK Ltd., Huntingdon, Cambridgeshire, England
- Age at study initiation: 10 to 13 weeks.
- Weight at study initiation: 2.3 to 3.0 kg
- Housing: Housed individually in metal cages with perforated floors
- Diet : SDS Stanrab (P) SQC Rabbit Diet, provided ad libitum
- Water: mains drinking water provided ad libitum
- Acclimation period: 18 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 15.5 to 21.5°C
- Humidity (%): 50 to 74%
- Air changes (per hr): 19 hours
- Photoperiod: 12 hours artificial light per 24 hour period
IN-LIFE DATES: From: 21 July 1997 To: 26 July 1997 - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The eye contralateral to the treated eye remained untreated in each animal
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Duration of treatment / exposure:
- Not applicable - a single instillation of test substance was made with no subsequent washing.
- Observation period (in vivo):
- 3 days (observations made 1, 24, 48, and 72 hours after instillation).
- Number of animals or in vitro replicates:
- Six
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): None
SCORING SYSTEM: The scoring system used is consistent with that described in OECD test Guideline 405.
TOOL USED TO ASSESS SCORE: handheld light - Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.11
- Max. score:
- 0.33
- Reversibility:
- fully reversible within: 2 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.11
- Max. score:
- 0.33
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- Instillation of DPGDB into the rabbit eye did not elicit a positive response according to the established test criteria.
A single instillation of DPGDB into the eye of the rabbit elicited transient very slight conjunctival irritation. - Other effects:
- There were no signs of ill health in any rabbit during the observation period.
- Interpretation of results:
- other: Not irritating
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- Instillation of DPGDB into the eye of the rabbit did not elicit a positive response according to the established test criteria.
A single instillation of DPGDB into the eye of the rabbit elicited transient very slight conjunctival irritation. - Executive summary:
Key data is available for propylene glycol dibenzoate (PGDB). This data is supported by relevant information available from a structural analogue Dipropylene glycol dibenzoate (DPGDB). The justification for read across is presented as an attachment included in Section 13 of the IUCLID dossier.
A study was performed to assess the eye irritation potential of DPGDB to the rabbit. The study was conducted in accordance with OECD, EC, US EPA and Japanese test guidelines, and in compliance with GLP.
Approximately 0.1 mL of the test substance was instilled into one eye of 6 rabbits, and the effects observed for 72 hours. The eyes were not rinsed after instillation of the test material.
Transient hyperaemia of blood vessels only was observed in all animals. These reactions had resolved in all instances by one or two days after instillation. No corneal damage or iridial inflammation was observed.
There were no signs of toxicity or ill health in any of the rabbits during the observation period.
Instillation of DPGDB into the rabbit eye did not elicit a positive response according to the established test criteria. DPGDB is not irritant to the eye.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 798.4500 (Acute Eye Irritation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- Note - study report refers to the guideline as number 404 "Acute Eye Irritation / corrosion", adopted 24 February 1987.
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: JMAFF, Requirements for Safety Evaluation of Agricultural Chemicals and Testing Guidelines for Toxicology Studies, Primary Eye Irritation Study, 59 NohSan No 4200, Agricultural Production Bureau, January 28, 1985.
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Benzoflex 9-88
- IUPAC Name:
- Benzoflex 9-88
- Reference substance name:
- Oxydipropyl dibenzoate
- EC Number:
- 248-258-5
- EC Name:
- Oxydipropyl dibenzoate
- Cas Number:
- 27138-31-4
- Molecular formula:
- C20H22O5
- IUPAC Name:
- oxydipropyl dibenzoate
- Details on test material:
- - Name of test material (as cited in study report): Benzoflex 9-88 (Dipropylene glycol dibenzoate DPGDB)
- Physical state: Clear colourless liquid
- Storage condition of test material: Room temperature
Constituent 1
Constituent 2
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Harlan Interfauna UK Ltd., Huntingdon, Cambridgeshire, England
- Age at study initiation: 10 to 13 weeks.
- Weight at study initiation: 2.3 to 3.0 kg
- Housing: Housed individually in metal cages with perforated floors
- Diet : SDS Stanrab (P) SQC Rabbit Diet, provided ad libitum
- Water: mains drinking water provided ad libitum
- Acclimation period: 18 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 15.5 to 21.5°C
- Humidity (%): 50 to 74%
- Air changes (per hr): 19 hours
- Photoperiod: 12 hours artificial light per 24 hour period
IN-LIFE DATES: From: 21 July 1997 To: 26 July 1997
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The eye contralateral to the treated eye remained untreated in each animal
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Duration of treatment / exposure:
- Not applicable - a single instillation of test substance was made with no subsequent washing.
- Observation period (in vivo):
- 3 days (observations made 1, 24, 48, and 72 hours after instillation).
- Number of animals or in vitro replicates:
- Six
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): None
SCORING SYSTEM: The scoring system used is consistent with that described in OECD test Guideline 405.
TOOL USED TO ASSESS SCORE: handheld light
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.11
- Max. score:
- 0.33
- Reversibility:
- fully reversible within: 2 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.11
- Max. score:
- 0.33
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- Instillation of DPGDB into the rabbit eye did not elicit a positive response according to the established test criteria.
A single instillation of DPGDB into the eye of the rabbit elicited transient very slight conjunctival irritation. - Other effects:
- There were no signs of ill health in any rabbit during the observation period.
Applicant's summary and conclusion
- Interpretation of results:
- other: Not irritating
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- Instillation of DPGDB into the eye of the rabbit did not elicit a positive response according to the established test criteria.
A single instillation of DPGDB into the eye of the rabbit elicited transient very slight conjunctival irritation. - Executive summary:
Key data is available for propylene glycol dibenzoate (PGDB). This data is supported by relevant information available from a structural analogue Dipropylene glycol dibenzoate (DPGDB). The justification for read across is presented as an attachment included in Section 13 of the IUCLID dossier.
A study was performed to assess the eye irritation potential of DPGDB to the rabbit. The study was conducted in accordance with OECD, EC, US EPA and Japanese test guidelines, and in compliance with GLP.
Approximately 0.1 mL of the test substance was instilled into one eye of 6 rabbits, and the effects observed for 72 hours. The eyes were not rinsed after instillation of the test material.
Transient hyperaemia of blood vessels only was observed in all animals. These reactions had resolved in all instances by one or two days after instillation. No corneal damage or iridial inflammation was observed.
There were no signs of toxicity or ill health in any of the rabbits during the observation period.
Instillation of DPGDB into the rabbit eye did not elicit a positive response according to the established test criteria. DPGDB is not an irritant to the eye.
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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