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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:
1984
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Similar to guideline study design. Animals were simultaneously exposed at different application sites to ethoxypropanol and two marine fuel mixtures. One animal was also used in an eye irritation study during the acclimation period.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Qualifier:
equivalent or similar to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
yes
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Ethoxypropanol
- Physical state: Liquid
- Analytical purity: 91.1%
- Impurities (identity and concentrations):
8.0% 2-ethoxy-1-propanol
0.7% 1-methoxy-2-propanol
0.1% 2-methoxy-1-propanol
0.04% 1-(2-propenyloxy)-2-propanol
- Purity test date: 6 June 1983
- Lot/batch No.: Batch No. 96 from BP Chemie, Lavera
- Storage condition of test material: In the dark at room temperature

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
Each animal was uniquely identified by an ear tattoo
- Source: Ranch Rabbits, Crawley Down, Sussex, England
- Housing: Individually in aluminium cages with grid floors
- Diet: Ad libitum access to Guinea Pig Maintenance Diet from Special Diet Services, Witham, Essex.
- Water: Ad libitum access to water supplied by the North Surrey Water Company
- Acclimation period: 22 days

ENVIRONMENTAL CONDITIONS
- Temperature: 18 - 24 degrees C
- Humidity: 36 - 62 % relative humidity
- Photoperiod: 12-hour light: 12-hour dark cycle

IN-LIFE DATES: From: To:
Between 24 April and 1 May, 1984

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
Duration of treatment / exposure:
4 hours
Observation period:
Examination of the treated skin was made approximately 1, 24, 48 and 72 hours and 7 days after removal of the patches.
Number of animals:
Three
Details on study design:
TEST SITE
- Area of exposure: 2.5 cm square
- Type of wrap if used: Semi-occlusive guaze dressing held in place by a tightly fitting tubular muslin bandage stretched over the whole torso and Sleek tape.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): No obvious test material remained after removal of the patches. No decontamination was performed.

SCORING SYSTEM: Draize et al, 1944.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 hour
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: effect seen in one rabbit out of 3. Slight flaking of skin on patch site
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 hour
Score:
0
Max. score:
4
Reversibility:
other: no effects seen
Irritant / corrosive response data:
Slight redness was recorded in two animals at 1 hour and 24 hours after exposure. No other signs of irritation were recorded.
Other effects:
Slight flaking of the skin was also noted at the patch sites of these two animals, which was resolved within 7 days.

Any other information on results incl. tables

Individual animal results

Animal #

Reaction

24 hours

48 hours

72 hours

1

E

1*

0*

0*

O

0

0

0

2

E

1

0*

0*

O

0

0

0

3

E

0

0

0

O

0

0

0

Reaction: E=Erythema, O=Odema

*=slight flaking skin on patch site

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 ethoxypropanol to intact rabbit skin for 4 hours elicited minimal transient dermal irritation
Executive summary:

In a GLP in vivo rabbit skin irritation study, a single semi-occlusive application of ethoxypropanol for 4 hours elicited minimal transient dermal irritation, which cleared within 48 hours.  Flaking of the skin was also noted, which cleared within 7 days.