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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:
4 hours contact, 10 days total
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study - original study report available

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report Date:
1986

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Principles of method if other than guideline:
Conformed to recommendations of the OECD Short-Term and Long-Term Toxicology Groups Final Report, Paris 1981; ISBN 92-64-12221-4
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): Ethoxypropoxy Propanol (synonym of Dipropylene glycol monoethyl ester).
- Physical state: A clear colourless liquid
- Analytical purity: Not specified
- Impurities (identity and concentrations): Not specified
Purity test date: Not specified
- Lot/batch No. GOHC laboratory Sample No. 1030, Oil Stock Ref. No. 09977, 134/109
- Expiration date of the lot/batch: Not specified
- Stability under test conditions: Not specified.
- Storage condition of test material: At ambient temperature in brown screw-capped bottle.
- Other: None

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: C&J Morton (Stansted Ltd)
- Age at study initiation: ~3 months
- Weight at study initiation: 2.84-2.97 kg
- Housing: Individually in suspended, mesh-floored cages
- Diet (e.g. ad libitum): Commercially available pelleted standard rabbit diet ad libitum
- Water (e.g. ad libitum): mains supply, ad libitum
- Acclimation period: 6 days.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 (10-25)
- Humidity (%): 50 (40-75)
- Air changes (per hr): 12 (no recirculation)
- Photoperiod (hrs dark / hrs light): 10/14

IN-LIFE DATES: From: 1985-10-22 TO 1985-10-31

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
- Concentration (if solution): neat

VEHICLE
- Amount(s) applied (volume or weight with unit): None
Duration of treatment / exposure:
4 hours
Observation period:
24, 48 and 72 hours; 10 days
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 3 x 2 cm
- % coverage: 100
- Type of wrap if used: Blenderm (3-M Company)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): warm water and dried with paper towel
- Time after start of exposure: 4 hours

SCORING SYSTEM: After Draize:
ERYTHEMA
No erythema 0
very slight 1
well-defined 2
moderate to severe 3
severe erythema to slight eschar 4
OEDEMA
No oedema 0
very slight 1
slight 2
moderate 3
severe (raised more than 1 mm) 4

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 1 hr after removal of dressing
Score:
> 0 - < 2
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 1 hr after removal of dressing
Score:
> 0 - ca. 1
Max. score:
0
Remarks on result:
other: Individual scores 0
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 hours after dressing removed
Score:
> 0 - ca. 1
Max. score:
1
Remarks on result:
other: One rabbit had score of 1
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 hours after dressing removed
Score:
ca. 0 - <= 1
Max. score:
0
Remarks on result:
other: All rabbits scored 0
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 48 & 72 hours; Day 10
Score:
ca. 0 - <= 1
Max. score:
0
Remarks on result:
other: All three rabbits scored 0 for both erythema and oedema at all time points.
Irritant / corrosive response data:
Not irritant
Other effects:
Occasional exfoliation following slight erythema.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: Official Journal EC L257/8 Vol 26, 16/9/83 and L257/19. Vol 26, 16/9/83
Conclusions:
Not irritating
Executive summary:

This well conducted key study using OECD method prior to its adoption as method OECD 404 demonstrates a lack of dermal irritancy in this model. Mean maximum scores (1) were below the GHS criteria of >=1.5 for optional classification as Category 3 (mild irritant).