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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

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

Constituent 1
Chemical structure
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

Resultsopen allclose all
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
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
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
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
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
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).