Registration Dossier
Registration Dossier
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EC number: 242-894-7 | CAS number: 19224-26-1
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 16 July 1997 - 30 July 1997
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to EPA, EEC, OECD, and Japanese test guidelines, and in compliance with GLP.
- 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:
- acute toxicity: dermal
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 16 July 1997 - 30 July 1997
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to EPA, EEC, OECD, and Japanese test guidelines, and in compliance with GLP.
- 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 798.1100 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Japan Ministry of International Trade and Industry (MITI), Directive, concerning the conduct of acute toxicity studies.
- Deviations:
- no
- GLP compliance:
- yes
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan UK Ltd, Bicester, Oxon, England
- Age at study initiation: seven to eight weeks
- Weight at study initiation: 232 to 257 g
- Housing: Housed individually in metal cages with wire mesh floors
- Diet (e.g. ad libitum): Standard laboratory rodent diet, Special Diet Services RM1(E) SQC expanded pellet, available ad libitum
- Water (e.g. ad libitum): Drinking water was made available ad libitum
- Acclimation period: A minimum of six days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 to 24.5°C
- Humidity (%): 45 - 63%
- Air changes (per hr): 10 to 15
- Photoperiod: 12 hourrs per 24 hour period
IN-LIFE DATES: From: 16 July 1997 To: 30 July 1997 - Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: approimately 50 x 50 mm.
- % coverage: Approximately 10% of the total body surface area
- Type of wrap if used: Porous gauze held in place with a non-irritating dressing further covered by a waterproof dressing
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The skin was washed with warm water (30 to 40°C), then blotted dry with absorbent paper
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw
- Constant volume or concentration used: no (variable amount depending on bodyweight of test animal)
- Duration of exposure:
- 24 hours
- Doses:
- Single limit dose of 2000 mg/kg bodyweight
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations for mortality and clinical signs were performed at least twice daily. Body weights were recorded on days 1 (Prior to dosing), 8, and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, macroscopic pathology - Preliminary study:
- None
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- There were no deaths following a single dermal application of dose of DPGDB to a group of ten rats (five males and five females) at a dosage of 2000 mg/kg bodyweight.
- Clinical signs:
- other: There were no signs of systemic reaction to treatment observed in any animal throughout the study.
- Gross pathology:
- No abnormalities were recorded at the macroscopic examination on Day 15.
- Interpretation of results:
- other: Not classified
- Remarks:
- According to Directive 67/548/EEC Criteria used for interpretation of results: EU
- Conclusions:
- The acute lethal dermal dose to rats of DPGDB was demonstrated to be greater than 2000 mg/Kg bodyweight.
- 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 acute dermal toxicity of the test material DPGDB when administered to rats. The study was conducted according to OECD, EC, US EPA, and Japanese (MITI) test guidelines, and in compliance with GLP.
Ten rats (five males and five females) were exposed to a single 2000 mg/Kg dose of DPGDB by the dermal route for 24 hours, then observed for 14 days following test material removal.
No rats died during the observation period and no clinical or pathological signs were observed. No dermal response to treatment was observed in any animal. No abnormalities were observed during macroscopic examination at study termination.
The acute lethal dermal dose to rats of DPGDB was demonstrated to be greater than 2000 mg/Kg bodyweight.
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 798.1100 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Japan Ministry of International Trade and Industry (MITI), Directive, concerning the conduct of acute toxicity studies.
- Deviations:
- no
- GLP compliance:
- yes
- Limit test:
- 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
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan UK Ltd, Bicester, Oxon, England
- Age at study initiation: seven to eight weeks
- Weight at study initiation: 232 to 257 g
- Housing: Housed individually in metal cages with wire mesh floors
- Diet (e.g. ad libitum): Standard laboratory rodent diet, Special Diet Services RM1(E) SQC expanded pellet, available ad libitum
- Water (e.g. ad libitum): Drinking water was made available ad libitum
- Acclimation period: A minimum of six days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 to 24.5°C
- Humidity (%): 45 - 63%
- Air changes (per hr): 10 to 15
- Photoperiod: 12 hourrs per 24 hour period
IN-LIFE DATES: From: 16 July 1997 To: 30 July 1997
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: approimately 50 x 50 mm.
- % coverage: Approximately 10% of the total body surface area
- Type of wrap if used: Porous gauze held in place with a non-irritating dressing further covered by a waterproof dressing
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The skin was washed with warm water (30 to 40°C), then blotted dry with absorbent paper
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw
- Constant volume or concentration used: no (variable amount depending on bodyweight of test animal)
- Duration of exposure:
- 24 hours
- Doses:
- Single limit dose of 2000 mg/kg bodyweight
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations for mortality and clinical signs were performed at least twice daily. Body weights were recorded on days 1 (Prior to dosing), 8, and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, macroscopic pathology
Results and discussion
- Preliminary study:
- None
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- There were no deaths following a single dermal application of dose of DPGDB to a group of ten rats (five males and five females) at a dosage of 2000 mg/kg bodyweight.
- Clinical signs:
- other: There were no signs of systemic reaction to treatment observed in any animal throughout the study.
- Gross pathology:
- No abnormalities were recorded at the macroscopic examination on Day 15.
Applicant's summary and conclusion
- Interpretation of results:
- other: Not classified
- Remarks:
- According to Directive 67/548/EEC Criteria used for interpretation of results: EU
- Conclusions:
- The acute lethal dermal dose to rats of DPGDB was demonstrated to be greater than 2000 mg/Kg bodyweight.
- 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 acute dermal toxicity of the test material DPGDB when administered to rats. The study was conducted according to OECD, EC, US EPA, and Japanese (MITI) test guidelines, and in compliance with GLP.
Ten rats (five males and five females) were exposed to a single 2000 mg/Kg dose of DPGDB by the dermal route for 24 hours, then observed for 14 days following test material removal.
No rats died during the observation period and no clinical or pathological signs were observed. No dermal response to treatment was observed in any animal. No abnormalities were observed during macroscopic examination at study termination.
The acute lethal dermal dose to rats of DPGDB was demonstrated to be greater than 2000 mg/Kg bodyweight.
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