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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions (pre-GLP; application time 20 h; occlusive coverage; only 2 animals used; short observation period (8 days)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1970
Report date:
1970

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Principles of method if other than guideline:
The test substance was applied to a 2.5 x 2.5 cm application site of white Vienna rabbits for 20 h under occlusive conditions. The skin was intact. After the application time, the skin was washed with water which may have contained a mild detergent. Animals were observed for 8 days and skin changes were observed on working days. Findings were recorded after 24 and 48 hours and at the end of the observation period. Findings were graded as described in OECD guideline 404 (according to Draize).
GLP compliance:
no
Remarks:
GLP was not compulsory at the time the study was conducted

Test material

Constituent 1
Reference substance name:
Ethylhexylchloride
IUPAC Name:
Ethylhexylchloride
Details on test material:
- Name of test material (as cited in study report): Ethylhexylchloride
- Physical state: liquid
- Purity: ca. 98%

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Gaukler
- Age at study initiation: young adult
- Weight at study initiation: animal 1: 2.13 kg; animal 2: 2.21 kg
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated skin of same animal
Amount / concentration applied:
TEST MATERIAL
- Amount applied (volume): approx. 0.5 ml
- Concentration (if solution): undiluted
Duration of treatment / exposure:
The test substance was applied for 1 min, 5 min, 15 min and 20 h. The irritation scores from the 20-hour exposure period were taken to assess skin irritation by the test substance.
Observation period:
8 days
Number of animals:
2 (males)
Details on study design:
TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm
- Type of wrap if used: occlusive

REMOVAL OF TEST SUBSTANCE
- Washing: yes, with water which may have contained a mild detergent
- Time after start of exposure: 1 min, 5 min, 15 min, 20 h

SCORING SYSTEM: as described in OECD guideline 404 (according to Draize)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24-48 hours
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: 20 h occlusive exposure, 72-hour assessment timepoint missing, short observation period (8 days)
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24-48 hours
Score:
2.5
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: 20 h occlusive exposure, 72-hour assessment timepoint missing, short observation period (8 days)
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 24-48 hours
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: squamation
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 24-48 hours
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: squamation
Irritant / corrosive response data:
See table below.
Other effects:
- Weight at study termination: animal 1: 2.38 kg; animal 2: 2.3 kg

Any other information on results incl. tables

Irritation scores (20 h occlusive exposure):

Timepoint

Animal No.

Intact skin

Symptoms

Erythema

Edema

24 h

1

3

0

 

2

2

0

 

48 h

1

3

0

 

2

3

0

 

8 d

1

2

0

Squamation

2

2

0

Squamation

Mean

24, 48 h

1

3

0

 

Mean

24, 48 h

2

2.5

0

 

 

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information
Conclusions:
According to the results of this study the test substance is considered to be irritating to the rabbit skin.