Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Acute Toxicity: dermal

Currently viewing:

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:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
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
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
Benzoflex 9-88
IUPAC Name:
Benzoflex 9-88
Constituent 2
Chemical structure
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

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
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:
not classified
Remarks:
Migrated information 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:

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.