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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
17 July 1997 - 20 July 1997
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to OECD, EC, EPA, and Japanese test guidelines, and in compliance with GLP.

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
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Benzoflex 2-45 (Diethylene glycol dibenzoate DEGDB)
- Physical state: Clear colourless liquid
- Analytical purity: Diethylene glycol dibenzoate - 89.9% (w/w)
- Impurities (identity and concentrations):
Diethylene glycol monobenzoate - 5.85% (w/w)
Dipropylene glycol dibenzoate - 1.50% (w/w)
Ethylene glycol dibenzoate - 0.19% (w/w)
Triethylene glycol dibenzoate - 0.15% (w/w)
Unidentified component 1 - 0.10% (w/w)
Unidentified component 2 - 0.10% (w/w)
Unidentified component 3 - 0.54% (w/w)
- Lot/batch No.: 56625030
- Expiration date of the lot/batch: 19 May 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, Cambrigeshire, England
- Age at study initiation: 11 to 13 weeks
- Weight at study initiation: 2.5 to 3.1 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 - 74%
- 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): Approximately 0.5 mL
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
Six males
(Note that the "animal management " section of the report states that 3 animals were used, however the results section lists data from 6 animals).
Details on study design:
TEST SITE
- Area of exposure: 25 mm 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 DEGDB to intact rabbit skin for four hours elicited no dermal irritation.
Executive summary:

A study was performed to assess the skin irritation potential of DEGDB to the rabbit. The study was conducted in accordance with EPA, OECD, EC, and Japanese test guidelines, and in compliance with GLP.

No dermal reactions were observed following a single semi-occlusive application of DEGDB to intact rabbit skin for four hours. DEGDB is not irritant to the skin.

DEGDB is not considered to be a primary skin irritant