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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation / corrosion, other
Remarks:
in vivo study performed
Type of information:
experimental study
Adequacy of study:
key study
Study period:
17 July 1997 - 20 July 1997
Reliability:
1 (reliable without restriction)

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:
EPA OTS 798.4470 (Acute Dermal Irritation)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
other: Japanese Ministry of Agriculture Forestry and Fisheries Requirements for Safety Evaluation of Agricultural Chemicals and Testing Guidelines for Toxicology Studies, Acute Dermal Irritation Study 59 NohSan No. 4200 Agricultural Production Bureau Jan 28 1985
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
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
- Analytical purity: Dipropylene glycol dibenzoate - 89.4% (w/w)
- Impurities (identity and concentrations):
Dipropylene glycol monobenzoate - 4.98% (w/w)
Propylene glycol dibenzoate - 2.29% (w/w)
Propylene glycol monobenzoate - 0.28% (w/w)
Propenyloxy propyl benzoate - 2.35% (w/w)
- Lot/batch No.: 56635211
- Expiration date of the lot/batch : September 1998
- Storage condition of test material: Room temperature

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Interfauna (UK) Ltd., Huntingdon, Cambridgeshire, England
- Age at study initiation: 10 to 12 weeks.
- Weight at study initiation: 2.4 to 2.8 kg
- Housing: Individually housed in metal cages with perforated floors
- Diet: access to SDS Stanrab (P) SQC Rabbit diet (ad libitum)
- Water (e.g. ad libitum): access to mains drinking water (ad libitum)
- Acclimation period: 14 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 15.5 to 21.5°C
- Humidity (%): 57 to 74%
- Air changes (per hr): 19
- Photoperiod: 12 hrs dark / 12 hrs light

- Air changes (per hr): approximately 19 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours artificial light per 24 hour period


IN-LIFE DATES: From: 17 July 1997 To: 20 July 1997

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: Hair removed with electric clippers
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5mL
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
6 males
Details on study design:
TEST SITE
- Area of exposure: 25 x 25 mm
- Type of wrap if used: Semi-occlusive gauze pad.


REMOVAL OF TEST SUBSTANCE
- Washing (if done): Treatment site washed with physiological saline.
- Time after start of exposure: 4 hours


SCORING SYSTEM: Consistent with the scoring system described in OECD test guideline 404.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: All time points (1, 24, 48 and 72 hours after exposure)
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
mean
Time point:
other: All time points (1, 24, 48 and 72 hours after exposure)
Score:
0
Max. score:
0
Reversibility:
other: Not applicable
Irritant / corrosive response data:
No dermal reaction to treatment was observed in any animal throughout the study
Other effects:
There were no signs of toxicity or ill health in any rabbit during the observation period.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
A single semi-occlusive application of DPGDB to intact rabbit skin for four hours elicited no dermal reaction..
Executive summary:

A study was performed to assess the skin 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 0.5 mL of the test substance was applied under a semi-occlusive gauze pad to 6 rabbits;  after a period of 4 hours the application site was washed with physiological saline. The animals were then observed for a period of 72 hours.

No dermal reactions were observed following this single semi-occlusive application of DPGDB to intact rabbit skin for four hours.

There were no signs of toxicity or ill health in any of the rabbits during the observation period.

Therefore DPGDB is not irritating to the skin and is not considered to be a primary skin irritant.