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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:
10.02.1987-16.02.1987
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic daten given. Report which meets basic scientific criteria.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report Date:
1987

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
May 12th, 1981
Deviations:
no
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Butyldiglykol, Diethylenglykolmonobutylether
- Physical state: liquid
- Analytical purity: >99%

Test animals

Species:
rabbit
Strain:
other: Small white Russian, Chbb-SPF
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Dr. Karl Thomae GmbH, Biberach, Germany
- Weight at study initiation: 2,1-2,3 kg
- Housing: stainless steel cages (one rabbit each)
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 14 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 1
- Humidity (%): 60 ± 5
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: To:

Test system

Type of coverage:
occlusive
Preparation of test site:
other: clipping of the fur
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0,5 cm3 of the undiluted test substance
Duration of treatment / exposure:
1 hour
Observation period:
8 days
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: approx. 6 cm2
- % coverage: 2,5 cm x 2,5 cm
- Type of wrap if used: Polyethylene foil


REMOVAL OF TEST SUBSTANCE
- Washing (if done): warm water
- Time after start of exposure: 4 hrs


SCORING SYSTEM
According to OECD guideline 404

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24, 48 and 72 hrs
Score:
1.67
Max. score:
4
Reversibility:
fully reversible within: 8 days
Remarks on result:
other: Dryness of application area noted at 72hrs. Flaking at day 6.
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 24, 48 and 72 hrs
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24, 48 and 72 h
Score:
1.67
Max. score:
4
Reversibility:
fully reversible within: 8 days
Remarks on result:
other: Flaking at day 6 only.
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 24, 48 and 72 hrs
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 hrs
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 24, 48 and 72 hrs
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 8 days
Remarks on result:
other: Dryness of application area noted at 72hrs. Flaking at day 6.
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 24, 48 and 72 hrs
Score:
1.33
Max. score:
4
Reversibility:
fully reversible within: 6 days

Any other information on results incl. tables

After the exposure period of 4 hours, slight to marked erythema were observed in the animals during the course of the study. The cutaneous reactions were reversible in all animals within 8 days after removal of the patch. Erythema in animals 1 and 3 were associated with skin dryness in the application area after 72 hrs and followed by scale formation after 6 days. The average irritation score (24 to 72 hours) was calculated to be 1,78 for erythema and 0,56 for edema.

Considering the described cutaneous reactions as well as the average score for irritation, the substance showed a slight skin irritation potential under the test conditions chosen but not sufficient to reach the criteria for classification as a skin irritant.

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Executive summary:

In a fully documented skin irritation study that followed the appropriate OECD guideline, three rabbits were used to assess the skin irritancy of 2 -(2 -butoxyethoxy)ethanol. Whilst all animals showed irritant effects with both erythema and odema observed, the level of severity seen along with the speed of recovery of the animals (all reversed) did not indicate that the substance should be classified as irritant in the EU.