Propanol, (2-ethoxymethylethoxy)-

Skin irritation / corrosion

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

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

Test material information

Constituent 1

Reference substance name:

-

EC Number:

405-820-6

EC Name:

-

Cas Number:

30025-38-8

Molecular formula:

C8H18O3

IUPAC Name:

reaction mass of 5-methyl-4,7-dioxa-2-nonanol and 6-methyl-4,7-dioxa-2-nonanol

Constituent 2

Reference substance name:

Dipropylene Glycol Monoethyl Ether

IUPAC Name:

Dipropylene Glycol Monoethyl Ether

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 or test system 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

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: no effects seen to reverse

Remarks on result:

no indication of irritation

Remarks:

very slight exfoliation seen at 48hr

Results 2

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: no effects seen to reverse

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: no effects seen to reverse

Remarks on result:

no indication of irritation

Remarks:

very slight exfoliation seen at 48 hrs

Results 4

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: no effects seen to reverse

Remarks on result:

no indication of irritation

Results 5

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: no effects seen to reverse

Remarks on result:

no indication of irritation

Remarks:

very slight exfoliation seen at 72 hrs

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: no effects seen to reverse

Remarks on result:

no indication of irritation

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).