Registration Dossier

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
29 Jan 1974 - 06 Feb 1974
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable study report which meets basic scientific principles.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
only two rabbits used. 20 hours exposure.
Principles of method if other than guideline:
Method: BASF-Test: Two animals were treated for 1, 5, 15 minutes and for 20 hours using occlusive conditions. An application site was covered with the liquid test substance. The animals were observed 8 days and skin changes were recorded daily. The report describes findings after 24 hours and at the end of the observation period (8 days). For a final evaluation, the findings after 48 and 72 hours from the raw data were taken into account.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Name of test material: 2-(2-(2-methoxyethoxy)ethoxy)ethanol. Test substance No. 88/289
- Physical state: liquid
- Analytical purity: ca. 95%
-Molecular formula C7H16O4
-IUPAC Name 2-[2-(2-methoxyethoxy)ethoxy]ethanol
-Synonyms Ethanol, 2- 2-(2-methoxyethoxy)ethoxy -
-Ethanol, 2-[2-(2-methoxyethoxy)ethoxy]-
-Molecular formula C7H16O4
-Molecular weight range 164.1995
-SMILES notation COCCOCCOCCO
-InChI InChI=1/C7H16O4/c1-9-4-5-11-7-6-10-3-2-8/h8H,2-7H2,1H3

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Gaukler
- Weight at study initiation: 2.63 kg (mean)

Test system

Type of coverage:
occlusive
Preparation of test site:
not specified
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
no data
Duration of treatment / exposure:
1 min, 5 min, 15 min, 20 h
Observation period:
8 days
Number of animals:
2
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: no data

REMOVAL OF TEST SUBSTANCE
- Washing (if done including time after start of exposure: After the application times (1, 5 and 15 min) the skin was washed with Lutrol (100%) and Lutrol solution (50%).

SCORING SYSTEM: The original BASF grading was converted into the numerical grading according to the OECD Draize system.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
0.17
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: 20 hours exposure time
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
4
Remarks on result:
other: 20 hours exposure time

Any other information on results incl. tables

Mean erythema score after 24, 48 and 72 h (animal1/animal2)

Exposure time

24h

48h

72h

mean

 

1min

0/0

0/0

0/0

0/0

 

5min

0/0

0/0

0/0

0/0

 

15min

0/0

0/0

0/0

0/0

 

20h

1/1

0/0

0/0

0.3/0.3

 

 

 

 

 

 

 

At the end of the observation period after 8 days no erythema were found.

Mean edema score after 24, 48 and 72 h (animal1/animal2)

Exposure time

24h

48h

72h

mean

 

1min

0/0

0/0

0/0

0/0

 

5min

0/0

0/0

0/0

0/0

 

15min

0/0

0/0

0/0

0/0

 

20h

0/0

0/0

0/0

0/0

 

 

 

 

 

 

 

At the end of the observation period after 8 days no edema were found. The test subsstance was not irritating.

 

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In a well reported skin irritancy study, the test substance 2-(2-(2 methoxyethoxy)ethoxy)ethanol or 2 -(2 -(2 -butoxyethoxy)ethoxy)ethanol, the subject of this dossier) is expected to exhibit very similar toxicity due to its close structural similarity to 2-(2-(2-methoxyethoxy)ethoxy)ethanol was applied under occluded conditions to rabbit skin for exposure periods of up to 20 hours.
The test substance was then washed before observing the animals for a period of up to 8 days. Mild erythema was seen in one of the two test animals but odema was not reported. Effects disappeared within 48 hours. On the basis of these results the substance is not regarded as a skin irritant.

Executive summary:

In a well reported skin irritancy study, the test substance 2-(2-(2methoxyethoxy)ethoxy)ethanol or 2 -(2 -(2 -butoxyethoxy)ethoxy)ethanol, the subject of this dossier) is expected to exhibit very similar toxicity due to its close structural similarity to2-(2-(2-methoxyethoxy)ethoxy)ethanolwas applied under occluded conditions to rabbit skin for exposure periods of up to 20 hours.

 The test substance was then washed before observing the animals for a period of up to 8 days. Mild erythema was seen in one of the two test animals but odema was not reported. Effects disappeared within 48 hours. On the basis of these results the substance is not regarded as a skin irritant.